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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19

    Summary
    EudraCT number
    		 2020-005416-22
    Trial protocol
    		 PT   ES  
    Global end of trial date
    24 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2023
    First version publication date
    28 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-540-5912
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04745351
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 South African Clinical Trials Register: DOH-27-012022-4779
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
    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. For studies with data uploaded using XML, this information will be populated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 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
    Portugal: 20
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United States: 184
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Brazil: 1
    Worldwide total number of subjects
    249
    EEA total number of subjects
    60
    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)
    96
    From 65 to 84 years
    121
    85 years and over
    32

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 258 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
    Arm description
    		 Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
    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 2-5.

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Infusion
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Arm title
    		 Placebo
    Arm description
    		 Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    RDV matching placebo IV saline administered on Days 1-5.

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Infusion
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Number of subjects in period 1 [1]
    		Remdesivir Placebo
    Started
    163
    80
    Completed
    95
    50
    Not completed
    68
    30
         Protocol violation
    1
    -
         Death
    51
    25
         Adverse event
    4
    -
         Lost to follow-up
    9
    3
         Withdrew consent
    1
    2
         Investigator's discretion
    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: 6 participants who were randomised but not treated were not included in the Safety Analysis Set for the overall study period reported in subject disposition section.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Remdesivir
    Reporting group description
    		 Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.

    Reporting group values
    		 Remdesivir Placebo Total
    Number of subjects
    		 163 80 243
    Age categorical
    Units: Subjects
        < 18 Years
    		 0 0 0
        >= 18 to < 65 Years
    		 70 22 92
        >= 65 Years
    		 93 58 151
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68 ( 14.1 ) 71 ( 13.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 71 33 104
        Male
    		 92 47 139
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 8 31
        Not Hispanic or Latino
    		 135 72 207
        Unknown or Not Reported
    		 5 0 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 4 2 6
        Black
    		 43 18 61
        Native Hawaiian or Pacific Islander
    		 1 0 1
        White
    		 104 55 159
        Other
    		 8 3 11
        Unknown or Not Reported
    		 2 2 4
    Clinical Status (8-point Ordinal Scale)
    The 8-point Ordinal scale assesses the clinical status of participants:1.Not hospitalized, no limitations on activities;2.Not hospitalized, limitation on activities/requiring home oxygen;3.Hospitalized,not requiring supplemental oxygen,no longer require ongoing medical care; 4.Hospitalized,not requiring supplemental oxygen-require ongoing medical care for COVID-19−specific medical care;5.Hospitalized,supplemental oxygen;6.Hospitalized,on noninvasive ventilation or highflow oxygen devices;7.Hospitalized,on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO);8.Death.
    Units: Subjects
        Score: 1
    		 0 0 0
        Score: 2
    		 0 0 0
        Score: 3
    		 0 0 0
        Score: 4
    		 36 18 54
        Score: 5
    		 97 47 144
        Score: 6
    		 30 15 45
        Score: 7
    		 0 0 0
        Score: 8
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Remdesivir
    Reporting group description
    		 Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.

    Primary: Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29

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    End point title
    		 Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
    End point description
    This is the combined endpoint reporting the percentage of participants with all-cause death or IMV through Day 29. Full Analysis Set included all participants who were randomised into the study and had received at least 1 dose of study drug. The reported percentage was from the Kaplan-Meier estimate.
    End point type
    Primary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    30.2
    33.5
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6132 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.816
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.504
         upper limit
    		 1.321
    Notes
    [1] - P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.

    Secondary: All-cause Mortality Through Day 29

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    End point title
    		 All-cause Mortality Through Day 29
    End point description
    The reported percentage was from the Kaplan-Meier estimate. Participants in the Full Analysis Set were analysed.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    25.9
    29.7
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3881 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.497
         upper limit
    		 1.388
    Notes
    [2] - P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.

    Secondary: Percentage of Participants With Initiation of IMV Through Day 29

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    End point title
    		 Percentage of Participants With Initiation of IMV Through Day 29
    End point description
    The reported percentage was the cumulative-incidence estimate. Participants in the Full Analysis Set were analysed.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    13.8
    12.8
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9116 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.043
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.493
         upper limit
    		 2.207
    Notes
    [3] - The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.

    Secondary: Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29

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    End point title
    		 Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
    End point description
    Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported. Participants in Full Analysis Set were analysed. 9999=Q3 was not estimable due to <75% of participants with recovery by Day 29.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: days
        median (inter-quartile range (Q1-Q3))
    20 (7 to 9999)
    19 (7 to 9999)
    No statistical analyses for this end point

    Secondary: Time to Recovery Independent of Further Worsening by Day 29

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    End point title
    		 Time to Recovery Independent of Further Worsening by Day 29
    End point description
    Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported. Participants in Full Analysis Set were analysed. 9999=Q3 was not estimable due to the <75% of participants with recovery by Day 29.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: days
        median (inter-quartile range (Q1-Q3))
    10 (6 to 9999)
    13 (6 to 9999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15

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    End point title
    		 Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
    End point description
    Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19−specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status. Participants in the Full Analysis Set were analysed.
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
    number (not applicable)
        Score: 1
    0
    0
        Score: 2
    48.5
    48.8
        Score: 3
    5.5
    2.5
        Score: 4
    9.2
    7.5
        Score: 5
    6.1
    11.3
        Score: 6
    8.0
    5.0
        Score: 7
    4.9
    6.3
        Score: 8
    17.8
    18.8
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8541 [4]
    Method
    		 Proportional odds model
    Confidence interval
    Notes
    [4] - P-value was analysed from proportional odds model including treatment as the independent variable.

    Secondary: Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29

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    End point title
    		 Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
    End point description
    Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status. Participants in the Full Analysis Set were analysed.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
    number (not applicable)
        Score: 1
    11.7
    16.3
        Score: 2
    42.9
    45.0
        Score: 3
    3.1
    2.5
        Score: 4
    4.3
    1.3
        Score: 5
    9.2
    2.5
        Score: 6
    1.8
    1.3
        Score: 7
    1.8
    2.5
        Score: 8
    25.2
    28.8
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4974 [5]
    Method
    		 Proportional odds model
    Confidence interval
    Notes
    [5] - P-value was analysed from proportional odds model including treatment as the independent variable.

    Secondary: Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29

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    End point title
    		 Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
    End point description
    The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT. Participants without ESKD at baseline in the Full Analysis Set with available data were analysed.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    104
    50
    Units: days
        median (full range (min-max))
    29 (1 to 29)
    29 (4 to 29)
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4283 [6]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - P-value was calculated based on Wilcoxon rank sum test.

    Secondary: Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29

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    End point title
    		 Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
    End point description
    Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    57.7
    63.8
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2773 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.731
         upper limit
    		 1.091
    Notes
    [7] - The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.

    Secondary: Percentage of Participants With Recovery Independent of Further Worsening Through Day 29

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    End point title
    		 Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
    End point description
    Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
    End point type
    Secondary
    End point timeframe
    First dose date up to Day 29
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    66.3
    67.5
    Statistical analysis title
    		 Statistical Analysis: Remdesivir vs Placebo
    Comparison groups
    Remdesivir v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7538 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Relative risk
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.819
         upper limit
    		 1.155
    Notes
    [8] - The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.

    Secondary: Percentage of Participants Experiencing Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants Experiencing Serious Adverse Events (SAEs)
    End point description
    An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs. Safety Analysis Set included all participants who were randomised into the study and had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    First dose date up to last dose date (Maximum: 5 days) plus 30 days
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    50.3
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug. Participants in the Safety Analysis Set were analysed.
    End point type
    Secondary
    End point timeframe
    First dose date up to last dose date (Maximum: 5 days)
    End point values
    		 Remdesivir Placebo
    Number of subjects analysed
    163
    80
    Units: percentage of participants
        number (not applicable)
    4.9
    1.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality: Randomisation up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
    Adverse event reporting additional description
    All-Cause Mortality: All Randomised Analysis Set included all participants who were randomised in the study. Adverse Events: Safety Analysis Set included all participants who were randomised into the study and had received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Remdesivir
    Reporting group description
    		 Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.

    Serious adverse events
    		 Remdesivir Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    82 / 163 (50.31%)
    40 / 80 (50.00%)
         number of deaths (all causes)
    55
    26
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    7 / 163 (4.29%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Shock
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Shock haemorrhagic
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    4 / 163 (2.45%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Death
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General physical health ~ deterioration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    7 / 163 (4.29%)
    10 / 80 (12.50%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    Acute respiratory failure
         subjects affected / exposed
    10 / 163 (6.13%)
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 6
    0 / 1
    Hypoxia
         subjects affected / exposed
    6 / 163 (3.68%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pneumothorax
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    3 / 163 (1.84%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dyspnoea
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         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
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Glomerular filtration rate abnormal
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dialysis related complication
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound haemorrhage
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    8 / 163 (4.91%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 7
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Atrial fibrillation
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (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
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic ischaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 163 (3.07%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal impairment
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    6 / 163 (3.68%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Sepsis
         subjects affected / exposed
    5 / 163 (3.07%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Covid-19
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Covid-19 pneumonia
         subjects affected / exposed
    3 / 163 (1.84%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Bacteraemia
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cytomegalovirus infection ~ reactivation
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacteroides bacteraemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperlipasaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 80 (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 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 163 (36.81%)
    34 / 80 (42.50%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    12 / 163 (7.36%)
    4 / 80 (5.00%)
         occurrences all number
    12
    5
    Hypertension
         subjects affected / exposed
    4 / 163 (2.45%)
    6 / 80 (7.50%)
         occurrences all number
    4
    7
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    7 / 163 (4.29%)
    4 / 80 (5.00%)
         occurrences all number
    7
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 163 (1.84%)
    4 / 80 (5.00%)
         occurrences all number
    3
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 163 (6.13%)
    1 / 80 (1.25%)
         occurrences all number
    13
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    12 / 163 (7.36%)
    7 / 80 (8.75%)
         occurrences all number
    12
    7
    Nausea
         subjects affected / exposed
    12 / 163 (7.36%)
    3 / 80 (3.75%)
         occurrences all number
    13
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 163 (3.07%)
    7 / 80 (8.75%)
         occurrences all number
    6
    7
    Agitation
         subjects affected / exposed
    5 / 163 (3.07%)
    4 / 80 (5.00%)
         occurrences all number
    5
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 163 (1.23%)
    4 / 80 (5.00%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    13 / 163 (7.98%)
    1 / 80 (1.25%)
         occurrences all number
    14
    1
    Hyperglycaemia
         subjects affected / exposed
    7 / 163 (4.29%)
    5 / 80 (6.25%)
         occurrences all number
    8
    5
    Hypoglycaemia
         subjects affected / exposed
    8 / 163 (4.91%)
    4 / 80 (5.00%)
         occurrences all number
    8
    4
    Hypokalaemia
         subjects affected / exposed
    5 / 163 (3.07%)
    7 / 80 (8.75%)
         occurrences all number
    5
    10
    Hypomagnesaemia
         subjects affected / exposed
    3 / 163 (1.84%)
    4 / 80 (5.00%)
         occurrences all number
    3
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jan 2021
    • Clarified study rationale to revise amount of sulfobutylether β-cyclodextrin sodium (SBECD) in 5-day course of RDV • Text was added to provide rationale for why dose adjustment was not appropriate due to metabolic pathways of RDV, and that RDV should be administered before hemodialysis if both fall on same day • Updated risk/benefit assessment to describe risk-benefit specific to study participants with severely reduced renal function who were hospitalized with COVID-19 • Primary objective was revised from all-cause death through Day 29, to a composite risk of IMV/death through Day 29 and endpoints were revised to reflect these changes • Amendments were made to descriptions of packaging, labeling for RDV and saline • Text was added to provide clear directions for concomitant medications use, to clarify personnel responsibilities for study drug accountability and handling of unused study drug, to further clarify management of clinically significant laboratory abnormalities, AEs • Updated study procedures sections and table • Numbers of participants from whom PK samples would be collected for intensive PK substudy and hemodialysis substudy were increased • Text was added to clarify details of first DMC meeting to review safety data and sample size re-estimation at second DMC meeting was removed so as not to enroll additional participants • An interim efficacy analysis was added per health authority recommendation so that study could be halted early due to either efficacy or futility • Updated statistical methods to reflect updated primary endpoint, to state that primary endpoint and key α-controlled secondary endpoint would be analysed at interim analysis, to clarify that their assessment would be based on interim analysis results and adjustments for multiplicity were added • Ratio for randomisation to RDV arm to placebo arm was changed from 1:1 to 2:1 to provide RDV to more participants, placebo to fewer participants per health authority feedback.
    02 Aug 2021
    • Increased the number of planned study centers to 150 • Expanded inclusion criteria to include participants with acute kidney injury (AKI) • Provided clarity on concomitant medications that are prohibited and allowed during the study, and account for current and future drug authorisations and approvals • Updated study procedures to capture vaccination status of participants • Provided clarity on conduction of sparse plasma PK assessments • Added IMV to follow-up visit in the study procedure table.
    27 Aug 2021
    • Clarified the inclusion criteria for AKI to specify that the increase in serum creatinine (SCr) should be sustained on repeat measurement • Clarified that urinalysis is not required in oliguric participants • Updated study procedures table to align with protocol changes.

    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.
    The study was terminated due to study enrollment feasibility. This decision was not based on efficacy or safety concerns.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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