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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting

    Summary
    EudraCT number
    		 2020-003510-12
    Trial protocol
    		 DK   GB   PT  
    Global end of trial date
    06 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2021
    First version publication date
    20 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-540-9012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04501952
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2020
    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
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Denmark: 10
    Country: Number of subjects enrolled
    United States: 552
    Worldwide total number of subjects
    584
    EEA total number of subjects
    27
    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)
    8
    Adults (18-64 years)
    479
    From 65 to 84 years
    93
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 18 September 2020. The last study visit occurred on 06 May 2021.

    Pre-assignment
    Screening details
    		 630 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Remdesivir (RDV)
    Arm description
    		 Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    Other name
    GS-5734™, Veklury®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered on Day 1 followed by 100 mg on Days 2 and 3

    Arm title
    		 Placebo
    Arm description
    		 Participants received IV placebo to match (PTM) RDV on Days 1 to 3.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    PTM RDV on Days 1 to 3

    Number of subjects in period 1 [1]
    		Remdesivir (RDV) Placebo
    Started
    279
    283
    Completed
    266
    272
    Not completed
    13
    11
         Withdrew Consent
    5
    4
         Adverse Event
    -
    3
         Investigator's Discretion
    -
    1
         Protocol Violation
    1
    1
         Lost to follow-up
    7
    2
    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: Thirteen participants in Remdesivir group and nine participants in the Placebo group were randomized but did not receive the study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Remdesivir (RDV)
    Reporting group description
    		 Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received IV placebo to match (PTM) RDV on Days 1 to 3.

    Reporting group values
    		 Remdesivir (RDV) Placebo Total
    Number of subjects
    		 279 283 562
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50 ± 15.3 51 ± 14.8 -
    Gender categorical
    Units: Subjects
        Female
    		 131 138 269
        Male
    		 148 145 293
    Race
    Not Permitted means local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    		 15 21 36
        Asian
    		 6 7 13
        Black
    		 20 22 42
        Native Hawaiian or Pacific Islander
    		 1 0 1
        White
    		 228 224 452
        Other
    		 3 2 5
        Not Permitted
    		 6 7 13
    Ethnicity
    Not Permitted means local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 123 112 235
        Not Hispanic or Latino
    		 146 158 304
        Not Permitted
    		 10 13 23

    End points

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    End points reporting groups
    Reporting group title
    Remdesivir (RDV)
    Reporting group description
    		 Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received IV placebo to match (PTM) RDV on Days 1 to 3.

    Primary: Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-cause Death by Day 28

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    End point title
    		 Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-cause Death by Day 28
    End point description
    The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    Randomization up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    279
    283
    Units: percentage of participants
        number (not applicable)
    0.7
    5.4
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    562
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0076 [2]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.134
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.031
         upper limit
    		 0.586
    Notes
    [1] - Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.
    [2] - p-value were estimated using the Cox regression with baseline stratification factors as covariates.

    Primary: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [3]
    End point description
    TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    First dose date up to last dose date (maximum: 3 days) plus 30 days
    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: No statistical comparison was planned or performed.
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    279
    283
    Units: percentage of participants
        number (not applicable)
    42.3
    46.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28

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    End point title
    		 Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28
    End point description
    The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. Modified Full Analysis Set included all participants who were randomized into the study, and received at least 1 dose of study treatment, and enrolled under protocol amendment 2 or later.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    246
    252
    Units: percentage of participants
        number (not applicable)
    1.7
    8.5
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.0024 [5]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.191
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.065
         upper limit
    		 0.555
    Notes
    [4] - Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
    [5] - p-value were estimated using the Cox regression with baseline stratification factors as covariates.

    Secondary: Percentage of Participants Who Died by Day 28

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    End point title
    		 Percentage of Participants Who Died by Day 28
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    266
    274
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With COVID-19 Related Hospitalization at Day 28

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    End point title
    		 Percentage of Participants With COVID-19 Related Hospitalization at Day 28
    End point description
    COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    279
    283
    Units: percentage of participants
        number (confidence interval 95%)
    0.7 (0.2 to 2.9)
    5.4 (3.3 to 8.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 14

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    End point title
    		 Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 14
    End point description
    The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 14
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    279
    283
    Units: percentage of participants
        number (not applicable)
    0.7
    5.4
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Placebo v Remdesivir (RDV)
    Number of subjects included in analysis
    562
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.0076 [7]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.134
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.031
         upper limit
    		 0.586
    Notes
    [6] - Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
    [7] - p-value were estimated using the Cox regression with baseline stratification factors as covariates.

    Secondary: Percentage of Participants With COVID-19 Related MAVs or All-cause Death by Day 14

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    End point title
    		 Percentage of Participants With COVID-19 Related MAVs or All-cause Death by Day 14
    End point description
    The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate. Participants in the modified Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 14
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    246
    252
    Units: percentage of participants
        number (not applicable)
    0.8
    8.0
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.0019 [9]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.023
         upper limit
    		 0.43
    Notes
    [8] - Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.
    [9] - p-value were estimated using the Cox regression with baseline stratification factors as covariates.

    Secondary: Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7

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    End point title
    		 Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
    End point description
    The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis. Participants in the Virology Analysis Set (all the participants who were randomized into the study, received at least 1 dose of study treatment, and had positive SARS-CoV-2 viral load at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 7
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    211
    208
    Units: log10 copies/mililiter (mL)
        arithmetic mean (standard deviation)
    -1.24 ± 1.123
    -1.14 ± 1.099
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.4318
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [10] - Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.

    Secondary: Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)

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    End point title
    		 Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)
    End point description
    The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date. Participants in the Full Analysis Set with available data were analyzed. 99999 indicates that not enough event to estimate Median and Inter-Quartile Range.
    End point type
    Secondary
    End point timeframe
    First Dose Date up to Day 14
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    66
    60
    Units: days
        median (inter-quartile range (Q1-Q3))
    99999 (10.0 to 99999)
    99999 (13.0 to 99999)
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2987 [11]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.405
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.733
         upper limit
    		 2.693
    Notes
    [11] - p-value was based on stratified log-rank test with baseline stratification factor as strata.

    Secondary: Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questinnaire

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    End point title
    		 Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questinnaire
    End point description
    The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptoms scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    23
    15
    Units: percentage of participants
        number (not applicable)
    30.4
    13.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Required Oxygen Supplementation by Day 28

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    End point title
    		 Percentage of Participants Who Required Oxygen Supplementation by Day 28
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Randomization up to Day 28
    End point values
    		 Remdesivir (RDV) Placebo
    Number of subjects analysed
    279
    283
    Units: percentage of participants
        number (not applicable)
    0.4
    1.8
    Statistical analysis title
    		 Remdesivir vs Placebo
    Comparison groups
    Remdesivir (RDV) v Placebo
    Number of subjects included in analysis
    562
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2163
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: First dose date up to 3 days plus 30 days; All-Cause Mortality: Randomization to the end of study (maximum: 59 days)
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment; All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study (i.e. participants exposed, Remdesivir=292, Placebo=292).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Remdesivir (RDV)
    Reporting group description
    		 Participants received a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients who received Placebo

    Serious adverse events
    		 Remdesivir (RDV) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 279 (1.79%)
    19 / 283 (6.71%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 279 (0.36%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 279 (0.72%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 279 (0.00%)
    3 / 283 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 279 (0.36%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 283 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19 pneumonia
         subjects affected / exposed
    0 / 279 (0.00%)
    7 / 283 (2.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 279 (0.72%)
    3 / 283 (1.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    1 / 279 (0.36%)
    2 / 283 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Viral myocarditis
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 283 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Remdesivir (RDV) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 279 (17.20%)
    49 / 283 (17.31%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 279 (5.73%)
    17 / 283 (6.01%)
         occurrences all number
    16
    17
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    30 / 279 (10.75%)
    21 / 283 (7.42%)
         occurrences all number
    31
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 279 (3.58%)
    18 / 283 (6.36%)
         occurrences all number
    10
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2020
    • Added ClinicalTrials.gov identifier • Increased the number of planned study centers to 150 to help complete enrollment within planned timelines • Removed restriction on percentage of participants that may be enrolled from skilled nursing facilities • Decreased minimum age to include adolescent participants ages ≥ 12 • Modified inclusion and exclusion criteria • Added sputum samples for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (RT- qPCR) viral load testing and possible resistance testing • Added study drug administration instructions • Revised Adverse Events • Removed Appendix Pandemic Risk Assessment and Mitigation Plan as it was not applicable for this study
    06 Nov 2020
    • Updates to endpoints in the study made in response to evolving treatment paradigms and understanding of COVID-19 • Updated General Information section to refer to the latest investigator brochure (IB) )• Addition of coagulation panel • Clarification and/or update of inclusion and exclusion criteria • Addition of complete physical examination requirements section
    12 Nov 2020
    • The secondary endpoint of time to alleviation of COVID-19 symptoms was returned back to secondary from exploratory after further consideration.
    14 Jan 2021
    • Updated primary and secondary study objectives to align with updated study endpoints • Updated primary and secondary study endpoints to address US regulatory agency comments • Updated exclusion criterion to clarify exclusion of COVID-19 vaccines • Updated study drugs’ storage and handling requirement • Updated statistical methods

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Apr 2021
    In April 2021, the study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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