Clinical Trial Results:
A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
Summary
|
|
EudraCT number |
2021-004535-84 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Jun 2022
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
22 Dec 2022
|
First version publication date |
22 Dec 2022
|
Other versions |
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 |
R10933-10987-COV-2114
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05092581 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Regeneron Pharmaceuticals, Inc
|
||
Sponsor organisation address |
777 Old Saw Mill River Rd., Tarrytown, United States, 10591
|
||
Public contact |
Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
|
||
Scientific contact |
Clinical Trial Management, Regeneron Pharmaceuticals, Inc, 001 8447346643, clinicaltrials@regeneron.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-002965-PIP01-21 EMEA-002964-PIP01-21 | ||
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? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
09 Jun 2022
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 Jun 2022
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
This was a phase 1b, open-label, single dose study in pediatric participants hospitalized due to COVID-19. The purpose of this study was to describe the pharmacokinetic profile of casirivimab+imdevimab when administered as treatment in the pediatric population and to demonstrate that a single intravenous dose of casirivimab+imdevimab was safe and tolerated in these participants.
|
||
Protection of trial subjects |
It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Dec 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 2
|
||
Worldwide total number of subjects |
2
|
||
EEA total number of subjects |
0
|
||
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) |
1
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
1
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||
Recruitment
|
||||||||||
Recruitment details |
- | |||||||||
Pre-assignment
|
||||||||||
Screening details |
As a result of the early termination, only 2 participants were enrolled in this study. | |||||||||
Period 1
|
||||||||||
Period 1 title |
Overall (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
Arm title
|
REGN10933+REGN10987 2400mg IV weight-based equivalent | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
REGN10933+REGN10987
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
casirivimab+imdevimab
|
|||||||||
Pharmaceutical forms |
Solution for injection
|
|||||||||
Routes of administration |
Intravenous use
|
|||||||||
Dosage and administration details |
Casirivimab+imdevimab drug products were supplied as liquid solutions for IV administration. A weight-based dose was intravenously administered to participants.
|
|||||||||
Arm title
|
REGN10933+REGN10987 8000mg IV weight-based equivalent | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
REGN10933+REGN10987
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
casirivimab+imdevimab
|
|||||||||
Pharmaceutical forms |
Solution for injection
|
|||||||||
Routes of administration |
Intravenous use
|
|||||||||
Dosage and administration details |
Casirivimab+imdevimab drug products were supplied as liquid solutions for IV administration. A weight-based dose was intravenously administered to participants.
|
|||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
REGN10933+REGN10987 2400mg IV weight-based equivalent
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
REGN10933+REGN10987 8000mg IV weight-based equivalent
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
REGN10933+REGN10987 2400mg IV weight-based equivalent
|
||
Reporting group description |
- | ||
Reporting group title |
REGN10933+REGN10987 8000mg IV weight-based equivalent
|
||
Reporting group description |
- |
|
||||||||||
End point title |
Proportion of participants with treatment-emergent serious adverse events (SAEs) [1] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Through 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: Statistical Analysis was not performed for this endpoint |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Proportion of participants with infusion-related reactions [2] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Through Day 4
|
|||||||||
Notes [2] - 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: Statistical Analysis was not performed for this endpoint |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Proportion of participants with hypersensitivity reactions [3] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Through 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: Statistical Analysis was not performed for this endpoint |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||
Timeframe for reporting adverse events |
From first dose to end of study, approximately 6 months.
|
|||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
25.0
|
|||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||
Reporting group title |
REGN10933+REGN10987 8000mg IV weight-based equivalent
|
|||||||||||||||||||||
Reporting group description |
REGN10933+REGN10987 8000mg intravenous (IV) weight-based equivalent | |||||||||||||||||||||
Reporting group title |
REGN10933+REGN10987 2400mg IV weight-based equivalent
|
|||||||||||||||||||||
Reporting group description |
REGN10933+REGN10987 2400mg intravenous (IV) weight-based equivalent | |||||||||||||||||||||
|
||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
This study was halted prematurely due to emerging SARS-CoV-2 variants impacting susceptibility to study drug. |