Clinical Trial Results:
A Multicenter, Randomized, Double-Blinded, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Materian in Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Summary
|
|
EudraCT number |
2021-000724-35 |
Trial protocol |
DE IT ES |
Global end of trial date |
06 Apr 2022
|
Results information
|
|
Results version number |
v2(current) |
This version publication date |
21 Apr 2023
|
First version publication date |
01 Nov 2022
|
Other versions |
v1 |
Version creation reason |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
VIR-7831-5006
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT04779879 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
VIR-7831-5006: 216912 | ||
Sponsors
|
|||
Sponsor organisation name |
Vir Biotechnology, Inc.
|
||
Sponsor organisation address |
499 Illinois St , San Francisco , United States, 94158
|
||
Public contact |
Study Inquiry, Vir Biotechnology, Inc., 415 6545281, clinicaltrials@vir.bio
|
||
Scientific contact |
Study Inquiry, Vir Biotechnology, Inc., clinicaltrials@vir.bio
|
||
Sponsor organisation name |
Vir Biotechnology, Inc.
|
||
Sponsor organisation address |
499 Illinois St , San Francisco , United States, 94158
|
||
Public contact |
n/a, GlaxoSmithKline (Ireland) Limited, 1415 6545281, na.na@na.com
|
||
Scientific contact |
n/a, GlaxoSmithKline (Ireland) Limited, 1415 6545281, na.na@na.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
29 Jun 2022
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
06 Apr 2022
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Safety (Part A): To evaluate the safety and tolerability profile of intravenous (IV) VIR-7831 Generation (Gen2) and IV Gen1
Pharmacodynamics (Part B): To evaluate the virological response of VIR-7831 Gen2 administered IV and via intramuscular (IM) injection in the upper respiratory tract
|
||
Protection of trial subjects |
Study participants were closely monitored for the occurrence of infusion reactions. The study intervention was administered in a clinic/study unit where participants were monitored closely for adverse events in the post-infusion period. Subsequent visits for study activities and clinical monitoring were conducted via clinic or home nursing visits (except for Week 16 which was a follow-up by telephone).
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Feb 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Canada: 28
|
||
Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 3
|
||
Country: Number of subjects enrolled |
United States: 276
|
||
Country: Number of subjects enrolled |
Spain: 46
|
||
Worldwide total number of subjects |
353
|
||
EEA total number of subjects |
46
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
337
|
||
From 65 to 84 years |
16
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||||
Recruitment details |
Randomized, parallel group study conducted in non-hospitalized participants with mild to moderate Coronavirus Disease 2019 (COVID-19) who received Sotrovimab (VIR-7831) Generation1 (Gen 1) and Gen2. | ||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||||
Screening details |
Total of 354 participants (30 participants in Part A, 167 participants in Part B, 157 participants in Part C) were enrolled in the study. | ||||||||||||||||||||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||||||||||||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part A- Sotrovimab Gen1: 500 mg IV | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IV infusion
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part A- Sotrovimab Gen2: 500 mg IV | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IV infusion
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part B- Sotrovimab Gen2: 500 mg IV | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IV infusion.
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part B- Sotrovimab Gen2: 500 mg IM | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IM administration.
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part C- Sotrovimab Gen2: 500 mg IV | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IV infusion
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Part C- Sotrovimab Gen2: 250 mg IM | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C. | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Sotrovimab was administered as IM injection
|
||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part A- Sotrovimab Gen1: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part A- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IM
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part C- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Part A- Sotrovimab Gen1: 500 mg IV
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A. | ||
Reporting group title |
Part A- Sotrovimab Gen2: 500 mg IV
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A. | ||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IV
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B. | ||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IM
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B. | ||
Reporting group title |
Part C- Sotrovimab Gen2: 500 mg IV
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C. | ||
Reporting group title |
Part C- Sotrovimab Gen2: 250 mg IM
|
||
Reporting group description |
Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C. | ||
Subject analysis set title |
Sotrovimab Gen2: 500 mg IV (Parts B and C)
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
|
|
||||||||||||||||
End point title |
Part A: Number of Participants With all Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 [1] [2] | |||||||||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
Safety Population consisted of all randomized participants who were exposed to study intervention.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 [3] [4] | ||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.
Safety Population.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
Up to Day 29
|
||||||||||||||||||
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 [5] [6] | |||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
Safety Population.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report. [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [7] [8] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Up to Day 29
|
|||||||||
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8) [9] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.
Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Day 1 to Day 8
|
||||||||||||
Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IV v Part B- Sotrovimab Gen2: 500 mg IM
|
||||||||||||
Number of subjects included in analysis |
129
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.04
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.98 | ||||||||||||
upper limit |
1.09 |
|
|||||||||||||
End point title |
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) [10] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Day 1 to Day 8
|
||||||||||||
Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
|
||||||||||||
Comparison groups |
Part C- Sotrovimab Gen2: 500 mg IV v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
117
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.02
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.94 | ||||||||||||
upper limit |
1.11 |
|
||||||||||
End point title |
Part A: Number of Participants With Non-Serious AEs Through Week 12 [11] | |||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were not Serious were considered as Non-Serious adverse events. Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 12
|
|||||||||
Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part A: Number of Participants With SAEs Through Week 24 [12] | |||||||||
End point description |
A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 24
|
|||||||||
Notes [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Part A: Number of Participants With AESI Through Week 24 [13] | ||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity. Safety Population.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Up to Week 24
|
||||||||||||||||||
Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points [14] | |||||||||||||||||||||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
Safety Population. Only those participants with data available at the specified time points were analyzed.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Days 1, 5, 11 and 85 (Week 12)
|
|||||||||||||||||||||||||||||||||
Notes [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24 [15] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 24
|
|||||||||
Notes [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Part B: Number of Participants With all AEs and SAEs Through Day 29 [16] | |||||||||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events. Safety Population
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Part B: Number of Participants With AESI Through Day 29 [17] | |||||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity. Safety Population.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||||||||
Notes [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 [18] | |||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Safety Population.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [19] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Day 29
|
|||||||||
Notes [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Part C: Number of Participants With All AEs and SAEs Through Day 29 [20] | |||||||||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events. Safety Population
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Part C: Number of Participants With AESI Through Day 29 [21] | |||||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity. Safety Population.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||||||||
Notes [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 [22] | |||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Safety Population.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Up to Day 29
|
|||||||||||||||
Notes [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 [23] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Day 29
|
|||||||||
Notes [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part B: Number of Participants With Non-Serious AEs Through Week 12 [24] | |||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 12
|
|||||||||
Notes [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part B: Number of Participants With SAEs Through Week 36 [25] | |||||||||
End point description |
A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 36
|
|||||||||
Notes [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Part B: Number of Participants With AESI Through Week 36 [26] | |||||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity. Safety Population.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Up to Week 36
|
|||||||||||||||||||||
Notes [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points [27] | |||||||||||||||||||||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Safety Population. Only those participants with data available at the specified time points were analyzed.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Days 1, 5, 11 and 85 (Week 12)
|
|||||||||||||||||||||||||||||||||
Notes [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part B: Number of Participants With Disease Progression Events Through Week 36 [28] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 36
|
|||||||||
Notes [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part C: Number of Participants With Non-Serious AEs Through Week 12 [29] | |||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 12
|
|||||||||
Notes [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part C: Number of Participants With SAEs Through Week 36 [30] | |||||||||
End point description |
A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 36
|
|||||||||
Notes [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Part C: Number of Participants With AESI Through Week 36 [31] | |||||||||||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity. Safety Population.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Up to Week 36
|
|||||||||||||||||||||
Notes [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points [32] | |||||||||||||||||||||||||||||||||
End point description |
Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Safety Population. Only those participants with data available at the specified data points were analyzed.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Days 1, 5, 11 and 85 (Week 12)
|
|||||||||||||||||||||||||||||||||
Notes [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Part C: Number of Participants With Disease Progression Events Through Week 36 [33] | |||||||||
End point description |
AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant’s current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE). Safety Population.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Up to Week 36
|
|||||||||
Notes [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Part A: Change from Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load [34] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and <2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Virology Population consisted of all participants in the Safety Population with a central lab confirmed quantifiable nasal mid-turbinate and/or saliva swab at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 2, 5, 8, 11, 15, 22 and 29
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: Change from Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples [35] | ||||||||||||||||||||||||||||||||||||
End point description |
Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
|
||||||||||||||||||||||||||||||||||||
Notes [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part C: Change from Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples [36] | ||||||||||||||||||||||||||||||||||||
End point description |
Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
|
||||||||||||||||||||||||||||||||||||
Notes [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: Percentage of Participants With Undetectable Viral Load [37] | ||||||||||||||||||||||||||||||||||||
End point description |
Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Days 2, 3, 5, 8, 11, 15, 22 and 29
|
||||||||||||||||||||||||||||||||||||
Notes [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part C: Percentage of Participants With Undetectable Viral Load [38] | ||||||||||||||||||||||||||||||||||||
End point description |
Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Days 2, 3, 5, 8, 11, 15, 22 and 29
|
||||||||||||||||||||||||||||||||||||
Notes [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) [39] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 to Day 5
|
||||||||||||
Notes [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IV v Part B- Sotrovimab Gen2: 500 mg IM
|
||||||||||||
Number of subjects included in analysis |
128
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.05
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1 | ||||||||||||
upper limit |
1.11 |
|
|||||||||||||
End point title |
Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) [40] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 to Day 11
|
||||||||||||
Notes [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IV v Part B- Sotrovimab Gen2: 500 mg IM
|
||||||||||||
Number of subjects included in analysis |
129
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.02
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.97 | ||||||||||||
upper limit |
1.07 |
|
|||||||||||||
End point title |
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) [41] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine). Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 to Day 5
|
||||||||||||
Notes [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
|
||||||||||||
Comparison groups |
Part C- Sotrovimab Gen2: 500 mg IV v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
120
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.01
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.93 | ||||||||||||
upper limit |
1.09 |
|
|||||||||||||
End point title |
Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) [42] | ||||||||||||
End point description |
AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine). Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 to Day 11
|
||||||||||||
Notes [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
|
||||||||||||
Comparison groups |
Part C- Sotrovimab Gen2: 500 mg IV v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
115
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.02
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.94 | ||||||||||||
upper limit |
1.1 |
|
|||||||||||||||||||
End point title |
Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 [43] | ||||||||||||||||||
End point description |
Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Day 8
|
||||||||||||||||||
Notes [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 [44] | ||||||||||||||||||
End point description |
Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off. Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Day 8
|
||||||||||||||||||
Notes [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Maximum Observed Concentration (Cmax) of VIR-7831 after IV administration [45] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values were considered as non-missing values). Only those participants with data available at the specified time points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Cmax of VIR-7831 after IV administration [46] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Cmax of VIR-7831 after IM administration [47] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Cmax of VIR-7831 after IV administration [48] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Cmax of VIR-7831 after IM administration [49] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 after IV administration [50] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Clast of VIR-7831 after IV administration [51] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Clast of VIR-7831 after IM administration [52] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Clast of VIR-7831 after IV administration [53] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Clast of VIR-7831 after IM administration [54] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Time to Reach Cmax (Tmax) of VIR-7831 after IV administration [55] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Tmax of VIR-7831 after IV administration [56] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Tmax of VIR-7831 after IM administration [57] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Tmax of VIR-7831 after IV administration [58] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Tmax of VIR-7831 after IM administration [59] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Time of the Last Quantifiable Concentration (tlast) of VIR-7831 after IV administration [60] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. The time frame is beyond Day 169 as there was one PK sample collected outside of the protocol defined window of +/- 7 days that was included in the analysis (PK sample collected up to Day 169 +/- 12 days).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: tlast of VIR-7831 after IV administration [61] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: tlast of VIR-7831 after IM administration [62] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: tlast of VIR-7831 after IV administration [63] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: tlast of VIR-7831 after IM administration [64] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: AUC from Day 1 to 29 (AUCD1-29) of VIR-7831 after IV administration [65] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29
|
||||||||||||
Notes [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUCD1-29 of VIR-7831 after IV administration [66] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
|
||||||||
Notes [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUCD1-29 of VIR-7831 after IM administration [67] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
|
||||||||
Notes [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUCD1-29 of VIR-7831 after IV administration [68] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
|
||||||||
Notes [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUCD1-29 of VIR-7831 after IM administration [69] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
|
||||||||
Notes [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 after IV administration [70] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUC(0-inf) of VIR-7831 after IV administration [71] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUC(0-inf) of VIR-7831 after IM administration [72] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUC(0-inf) of VIR-7831 after IV administration [73] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUC(0-inf) of VIR-7831 after IM administration [74] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 after IV administration [75] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUClast of VIR-7831 after IV administration [76] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: AUClast of VIR-7831 after IM administration [77] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [77] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUClast of VIR-7831 after IV administration [78] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: AUClast of VIR-7831 after IM administration [79] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Percentage of AUC(infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 after IV administration [80] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: %AUCexp of VIR-7831 after IV administration [81] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: %AUCexp of VIR-7831 after IM administration [82] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: %AUCexp of VIR-7831 after IV administration [83] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: %AUCexp of VIR-7831 after IM administration [84] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 after IV administration [85] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: t1/2 of VIR-7831 after IV administration [86] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: t1/2 of VIR-7831 after IM administration [87] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: t1/2 of VIR-7831 after IV administration [88] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: t1/2 of VIR-7831 after IM administration [89] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Apparent Volume of Distribution During the Elimination Phase following intravascular administrtion (Vz) of VIR-7831 [90] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Vz of VIR-7831 after IV administration [91] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [91] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Apparent Volume of Distribution During the Elimination Phase following extravascular administration (Vz/F) of VIR-7831 after IM administration [92] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Vz of VIR-7831 after IV administration [93] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Vz/F of VIR-7831 after IM administration [94] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 after IV administration [95] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Vss of VIR-7831 after IV administration [96] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: Vss of VIR-7831 after IV administration [97] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Part A: Clearance (CL) of VIR-7831 after IV administration [98] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
|
||||||||||||
Notes [98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: CL of VIR-7831 after IV administration [99] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part B: Apparent Clearance (CL/F) of VIR-7831 after IM administration [100] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
|
||||||||
Notes [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: CL of VIR-7831 after IV administration [101] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [101] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Part C: CL/F of VIR-7831 after IM administration [102] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||
Notes [102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C) [103] | ||||||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm. Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Data from Parts B and C is presented in a single outcome to determine the absolute bioavailability (F) based on the loge transformed dose normalized AUCinf for the IV (500 mg), IM (500 mg), and IM (250 mg). Data for 500 mg IV arms with similar dosing strategies across Parts B and C is combined as pre-specified in reporting and analysis plan.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||||||||||
Notes [103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||
Statistical analysis description |
Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.
|
||||||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IM v Sotrovimab Gen2: 500 mg IV (Parts B and C)
|
||||||||||||||||
Number of subjects included in analysis |
28
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other | ||||||||||||||||
Method |
|||||||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||||||
Point estimate |
0.66
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.48 | ||||||||||||||||
upper limit |
0.89 | ||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||
Statistical analysis description |
Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.
|
||||||||||||||||
Comparison groups |
Part C- Sotrovimab Gen2: 250 mg IM v Sotrovimab Gen2: 500 mg IV (Parts B and C)
|
||||||||||||||||
Number of subjects included in analysis |
28
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other | ||||||||||||||||
Method |
|||||||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||||||
Point estimate |
0.58
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
90% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.43 | ||||||||||||||||
upper limit |
0.79 |
|
|||||||||||||
End point title |
Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [104] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||||||
Notes [104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IM v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
16
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.14
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.67 | ||||||||||||
upper limit |
1.95 |
|
|||||||||||||
End point title |
Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [105] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||||||
Notes [105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IM v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
21
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.06
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.69 | ||||||||||||
upper limit |
1.62 |
|
|||||||||||||
End point title |
Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [106] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
|
||||||||||||
Notes [106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IM v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
21
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.11
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.68 | ||||||||||||
upper limit |
1.82 |
|
|||||||||||||
End point title |
Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) [107] | ||||||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
|
||||||||||||
Notes [107] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
|
||||||||||||
Comparison groups |
Part B- Sotrovimab Gen2: 500 mg IM v Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
Ratio of geometric least squares mean | ||||||||||||
Point estimate |
1.28
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.77 | ||||||||||||
upper limit |
2.12 |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Safety Population consisted of all randomized participants who were exposed to study intervention.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part C- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part A- Sotrovimab Gen1: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part A- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IM
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part C- Sotrovimab Gen2: 250 mg IM
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part B- Sotrovimab Gen2: 500 mg IV
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
19 Jan 2021 |
Amendment 1: Protocol changes have been made to include nasal mid-turbinate swabs and resistance testing at the request of regulatory agencies. |
||
03 Mar 2021 |
Amendment 2: Protocol changes have been made to add a second part (Part B) to this study to assess IM injection of VIR-7831 Gen2 material. The original treatment arms evaluating Gen2 and Gen1 material administered IV is designated Part A. Changes were made throughout the protocol to add information necessary for conducting Part B and to differentiate Part A and Part B procedures. Other changes include: removal of home nursing option for Part A study visits, an additional endpoint for the secondary safety objective for Part A, updates to endpoint wording for Part A, the addition of resistance analyses, updated background information based on new data, and clarifications throughout the protocol |
||
08 Apr 2021 |
Amendment 3: Adding measurement of anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibody at Baseline and Day 29 to the study procedures to allow for exploratory analysis of immune response. Removing the requirement that at least 15 participants are enrolled in Part A before enrollment in Part B can begin so that Part B can begin without delay |
||
18 May 2021 |
Amendment 4: Protocol changes have been made to add a third part (Part C) to this study to assess the safety, tolerability, immunogenicity, pharmacokinetics, and viral pharmacodynamics of a 250 milligram (mg) dose of VIR-7831 administered by IM injection. Changes were made throughout the protocol to add information necessary for conducting Part C procedures. Additionally, the post-dose monitoring time for Part B has been reduced to 1 hour after Joint Safety Review Team (JSRT) review on 13 May 2021. Other changes include: moving resistance analysis to an exploratory objective, providing updated data, clarification of inclusion and exclusion criteria, incorporated information from the Germany-specific protocol amendment, and other clarifications throughout the protocol. |
||
29 Oct 2021 |
Amendment 5: Expanded the safety follow-up of all active participants through Week 36 (~5 half lives of sotrovimab). |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |