Clinical Trial Results:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection
Summary
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EudraCT number |
2014-002137-58 |
Trial protocol |
GB BE IT NL |
Global end of trial date |
12 Apr 2017
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Results information
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Results version number |
v2(current) |
This version publication date |
18 May 2019
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First version publication date |
12 Apr 2018
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS-US-218-1227
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02135614 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Gilead Sciences
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Sponsor organisation address |
333 Lakeside Drive, Foster City, CA, United States, 94404
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Public contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Scientific contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Apr 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Mar 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Apr 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the effects of presatovir (GS-5806) on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms.
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Protection of trial subjects |
The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements.
This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Jun 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 3
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Country: Number of subjects enrolled |
Poland: 6
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Country: Number of subjects enrolled |
United Kingdom: 6
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Country: Number of subjects enrolled |
Belgium: 1
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Country: Number of subjects enrolled |
France: 35
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Israel: 58
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Country: Number of subjects enrolled |
United States: 29
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Country: Number of subjects enrolled |
New Zealand: 18
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Country: Number of subjects enrolled |
Australia: 16
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Country: Number of subjects enrolled |
Korea, Republic of: 16
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Worldwide total number of subjects |
189
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EEA total number of subjects |
52
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
73
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From 65 to 84 years |
98
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85 years and over |
18
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Recruitment
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Recruitment details |
Participants were enrolled at study sites in Australia, Europe, Asia, New Zealand, and the United States. The first participant was screened on 09 June 2014. The last study visit occurred on 12 April 2017. | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
833 participants were screened. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Presatovir | |||||||||||||||||||||||||||
Arm description |
Single dose of presatovir | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Presatovir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Single dose of presatovir 200 mg (4 x 50 mg tablets)
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Arm title
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Placebo | |||||||||||||||||||||||||||
Arm description |
Single dose of placebo | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Single dose of placebo
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 3 participants (Presatovir = 2; Placebo = 1) who were enrolled but not treated are not included in the subject disposition table. |
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Baseline characteristics reporting groups
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Reporting group title |
Presatovir
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Reporting group description |
Single dose of presatovir | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Single dose of placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Presatovir
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Reporting group description |
Single dose of presatovir | ||
Reporting group title |
Placebo
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Reporting group description |
Single dose of placebo |
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End point title |
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 | ||||||||||||
End point description |
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
The Evaluable Analysis Set included all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.
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End point type |
Primary
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End point timeframe |
Baseline to Day 5
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Statistical analysis title |
Statistical Analysis - Presatovir vs Placebo | ||||||||||||
Comparison groups |
Placebo v Presatovir
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Number of subjects included in analysis |
154
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.46 [1] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Treatment difference | ||||||||||||
Point estimate |
0.12
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.2 | ||||||||||||
upper limit |
0.43 | ||||||||||||
Notes [1] - P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates. |
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End point title |
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5 | ||||||||||||
End point description |
The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Participants in the Evaluable Analysis Set with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline to Day 5
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Statistical analysis title |
Statistical Analysis - Presatovir vs Placebo | ||||||||||||
Comparison groups |
Presatovir v Placebo
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Number of subjects included in analysis |
153
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.046 [2] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Treatment difference | ||||||||||||
Point estimate |
0.08
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||
upper limit |
0.16 | ||||||||||||
Notes [2] - P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates. |
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End point title |
Number of Hospitalization-Free Days Following Presatovir Administration | ||||||||||||
End point description |
The Evaluable Analysis Set included all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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Statistical analysis title |
Statistical Analysis - Presatovir vs Placebo | ||||||||||||
Comparison groups |
Presatovir v Placebo
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Number of subjects included in analysis |
154
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.39 [3] | ||||||||||||
Method |
Negative Binomial Model | ||||||||||||
Confidence interval |
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Notes [3] - P-value was calculated from the negative binomial model with the stratification factor as covariate. |
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End point title |
Rate of Unplanned Medical Encounters | ||||||||||||
End point description |
The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.
The Evaluable Analysis Set included all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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Statistical analysis title |
Statistical Analysis - Presatovir vs Placebo | ||||||||||||
Comparison groups |
Presatovir v Placebo
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Number of subjects included in analysis |
154
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.004 [4] | ||||||||||||
Method |
Negative Binomial Model | ||||||||||||
Confidence interval |
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Notes [4] - P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor. |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Day 28
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Adverse event reporting additional description |
Safety Analysis Set: all participants who received 1 dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Presatovir
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Reporting group description |
Single dose of presatovir | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Single dose of placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Mar 2014 |
● Added South Korea to the planned study centers and clarified which European countries had been selected to participate
● Clarified PK sampling time points on Days 1, 3, and 5
● Corrected the title of the Frailty Index to the Clinical Frailty Scale (CFS)
● Added an exclusion criterion for subjects requiring > 50% O2 when awake at screening
● Added an exclusion criteria for subjects scoring > 7 on the CFS at baseline
● Added RSV antibody titer blood draws at baseline and Day 14
● Added viral-coinfection testing at baseline, and clarified that RSV and influenza sampling and testing at screening was to follow local laboratory procedures
● Clarified the exclusion criteria for chronic systemic immunosuppressive agents and the exclusion criteria related to pneumonia
● Deleted the exclusion criteria related to life-expectancy and to heart failure
● Removed the Clinical Symptom Score assessment and the European Quality of Life 5-Dimension utility measure (EQ5D-5L) questionnaire
● Modified the Flu-PRO secondary endpoint from AUC of change in score from baseline to Day 7 to daily average change in the Flu-PRO score from baseline to Day 5, and updated the
Secondary Analysis sections accordingly
● Updated the Interim Analysis section to allow for an earlier assessment of futility and allow for study termination at a higher conditional power threshold
● Modified the primary endpoint from the AUC of log10 viral load from Day 1 to Day 7 to the daily average change in log10 viral load from Day 1 to Day 5, and updated the assumptions
used in the sample size calculation
● Deleted the total number of intensive care unit (ICU) transfers exploratory endpoint
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05 Aug 2014 |
● Modification of contraceptive requirements
● Addition of phototoxicity text to the dosage and administration information
● Addition of text to address potential for drug-drug interactions (DDI) to the prior and concomitant medication information
● Addition of the EudraCT Number and the ClinicalTrials.gov Identifier
● Updated the terminology of relevant endpoints from daily averages to time-weighted averages as this term, along with difference between time-weighted average post-baseline and baseline (DAVG), is often used in literature. The definitions and calculations of the endpoints remained the same.
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29 Aug 2014 |
● Updated the list of countries in which study centers were planned
● Modified inclusion criteria to allow hospitalizations due to respiratory or non-respiratory reasons and to clarify that either upper or lower respiratory tract symptoms were acceptable, instead of requiring both
● Expanded exclusion criterion related to prednisone use to include similar corticosteroids
● Removed exclusion criteria related to history of bleeding disorder and to arrhythmia
● Replaced exclusion criterion for HIV/AIDS and hepatitis B or C status with a criterion excluding cluster determinant 4 (CD4) counts indicative of immunocompromised subjects
● Modified exclusion criterion related to bacteremia and fungemia
● Replaced exclusion criteria related to cerebrovascular accident or stroke, and admission for trauma or planned and emergent surgeries with a broader exclusion criterion to exclude subjects with unstable medical conditions
● Modified exclusionary laboratory values for relevance in the elderly patient population
● Clarified the 2-part consent process
● Clarified the use of admissions records to support enrollment and baseline data
● Added telephone visit as an option for Day 28
● Administrative change to relocate collection of demographic information from baseline visit (Day 1) to screening (Day −1) in order to align with electronic data capture (EDC) requirements
● Administrative changes to Section 7.0 Adverse Events including rewording and reformatting for clarity
● Administrative change to update the sponsor address to the address of Gilead’s main headquarters
● Administrative change updating the primary medical monitor to Seth Toback, MD
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17 Nov 2015 |
● Added summary of the definitive embryo-fetal development study
● Added a section for ongoing clinical studies
● Completely revised the study design section for clarity
● Removed food-effect and phototoxicity wording from study drug dosing requirements
● Added End of Study and Post Study Care sections to the protocol
● Increased the number of study centers where the study was planned and added Hong Kong as a study location
● Clarified inclusion criterion for number of symptom days
● Added exclusion criterion for Middle East Respiratory Syndrome coronavirus (MERS-CoV) and other coronavirus coinfection
● Added moderate cytochrome P450 enzyme (CYP) inducers to the concomitant and prohibited medications
● Added recent historical evidence of pleural effusion and arterial blood pH to medical history requirements
● Added the option for home visits at Days 2, 3, 5, 7, and 14
● Added Day 21 visit
● Updated Flu-PRO instructions
● Added the EQ5D-5L
● Standardized O2 saturation procedure across protocols
● Added Supplemental Oxygen Use Diary
● Added an ECG to Day 14 and updated ECG before dosing at baseline to a mandatory requirement
● Added requirement for collection of clinical data related to cardiac testing
● Added troponin blood draws before and after dosing at baseline and added an additional troponin blood draw at Day 14
● Updated exploratory analyses based on the addition of the EQ5D-5L questionnaire. Analysis methods for other endpoints were also updated to include stratification factors in the model.
● Administrative change of all instances of GS-5806 to presatovir, excluding the study title
● Corrected typographical error in the EudraCT Number
● Administrative clarification that subjects could be discharged 30 minutes after dosing but were still required to complete all after dosing procedures
● Administrative addition of text regarding the Eligibility Criteria electronic case report form (eCRF) based off the new protocol template |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study. |