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    Clinical Trial Results:
    A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites

    Summary
    EudraCT number
    2020-001052-18
    Trial protocol
    DK   GB   DE   GR   ES  
    Global end of trial date
    10 Sep 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Apr 2021
    First version publication date
    01 Apr 2021
    Other versions
    Summary report(s)
    ACTT-1 final results
    ACTT-2 final results

    Trial information

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    Trial identification
    Sponsor protocol code
    010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04280705
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    DMID - NIH: 20-0006, Version no. 6.0
    Sponsors
    Sponsor organisation name
    US NIAID, Div. of Microbiology and Infectious Diseases (DMID) National Institute of Health (NIH)
    Sponsor organisation address
    5601 Fishers Lane, Bethesda, United States, MD 20892-9806
    Public contact
    Janice Arega, US NIAID, Div. of Microbiology and Infectious Diseases (DMID) National Institute of Health (NIH), +1 240292-0928, aregaj@niaid.nih.gov
    Scientific contact
    Janice Arega, US NIAID, Div. of Microbiology and Infectious Diseases (DMID) National Institute of Health (NIH), +1 240292-0928, aregaj@niaid.nih.gov
    Sponsor organisation name
    University of Minnesota
    Sponsor organisation address
    420 Johnston Hall, 101 Pleasant St. SE, Minneapolis, United States, 55455
    Public contact
    Eileen Denning, Coordinating Centers for Biometric Research, Div. of Biostatistics, School of Public Health, edenning@umn.edu
    Scientific contact
    James D. Neaton, Coordinating Centers for Biometric Research, Div. of Biostatistics, School of Public Health, neato001@umn.edu
    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
    09 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics for COVID-19 as compared to the control arm. In the first study of this platform trial reported here, remdesivir vs. placebo was studied.
    Protection of trial subjects
    No additional measures beyond usual care of individuals hospitalised with COVID-19.
    Background therapy
    none
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Mar 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
    Japan: 15
    Country: Number of subjects enrolled
    Korea, Republic of: 21
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Singapore: 16
    Country: Number of subjects enrolled
    United States: 837
    Country: Number of subjects enrolled
    Denmark: 43
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Greece: 33
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    United Kingdom: 46
    Worldwide total number of subjects
    1062
    EEA total number of subjects
    117
    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)
    678
    From 65 to 84 years
    340
    85 years and over
    44

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from participating hospitals between 21 Feb 2020 and 20 Apr 2020

    Pre-assignment
    Screening details
    Hospitalized adults with COVID-19

    Pre-assignment period milestones
    Number of subjects started
    1062
    Number of subjects completed
    1062

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor
    Blinding implementation details
    Randomizer was given a treatment ID, which was sent to the pharmacy. The ID was decoded in the pharmacy. A saline placebo infusion was used. The infusion bag was covered with a colored sleeve to mask the slight different in color between the active product and placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Normal saline given at equal volume on the same schedule
    Arm type
    Placebo

    Investigational medicinal product name
    normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A normal saline placebo will be given at an equal volume to the remdesivir infusion

    Arm title
    Remdesivir
    Arm description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
    Arm type
    Experimental

    Investigational medicinal product name
    remdesivir
    Investigational medicinal product code
    Other name
    Veklury
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course

    Number of subjects in period 1
    Placebo Remdesivir
    Started
    521
    541
    Received treatment
    517
    531
    Completed
    508
    517
    Not completed
    13
    24
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    4
         Enrolled but not treated
    4
    10
         Transferred to another hospital
    1
    1
         Consent withdrawn by subject
    7
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Normal saline given at equal volume on the same schedule

    Reporting group title
    Remdesivir
    Reporting group description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

    Reporting group values
    Placebo Remdesivir Total
    Number of subjects
    521 541 1062
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.2 ± 15.4 59.6 ± 14.6 -
    Gender categorical
    Units: Subjects
        Female
    189 189 378
        Male
    332 352 684

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Normal saline given at equal volume on the same schedule

    Reporting group title
    Remdesivir
    Reporting group description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

    Primary: Time to recovery

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    End point title
    Time to recovery
    End point description
    Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
    End point type
    Primary
    End point timeframe
    Day 1-29 (entire trial period)
    End point values
    Placebo Remdesivir
    Number of subjects analysed
    521
    541
    Units: days
        median (confidence interval 95%)
    15 (13 to 18)
    10 (9 to 11)
    Statistical analysis title
    Main analysis
    Comparison groups
    Placebo v Remdesivir
    Number of subjects included in analysis
    1062
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logrank
    Parameter type
    Cox proportional hazard
    Point estimate
    1.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.12
         upper limit
    1.49

    Secondary: Mean change in ordinal scale

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    End point title
    Mean change in ordinal scale
    End point description
    The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
    End point type
    Secondary
    End point timeframe
    Through Day 29. The ordinal scale was measured at Day 1, 3, 5, 8, 11, 15, 22, and 29
    End point values
    Placebo Remdesivir
    Number of subjects analysed
    518
    533
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.7 ± 2.3
    -2.3 ± 2.6
    No statistical analyses for this end point

    Secondary: Percentage of participants at each clinical status using ordinal scale at Day 15

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    End point title
    Percentage of participants at each clinical status using ordinal scale at Day 15
    End point description
    The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities
    End point type
    Secondary
    End point timeframe
    At Day 15
    End point values
    Placebo Remdesivir
    Number of subjects analysed
    521
    541
    Units: percent
    number (confidence interval 95%)
        Death at or before study visit
    11 (9 to 14)
    6 (5 to 9)
        Hospitalized, on invasive mech. vent. or ECMO
    22 (19 to 26)
    15 (13 to 19)
        hospitalized, on non-invasive vent./high flow O2
    4 (3 to 6)
    4 (3 to 6)
        Hospitalized, requiring supplemental O2
    11 (9 to 14)
    10 (8 to 13)
        Hospitalized, not on O2, requiring ongoing care
    6 (5 to 9)
    7 (5 to 9)
        Hospitalized, not requiring O2, no longer req care
    2 (1 to 3)
    3 (2 to 4)
        Not hospitalized, limit on activities/req home O2
    17 (14 to 21)
    19 (16 to 22)
        Not hospitalized, no limitations on activities
    22 (19 to 26)
    29 (25 to 33)
        No clinical status score reported - Hospitalized
    0 (0 to 1)
    0 (0 to 1)
        No clinical status score reported - Discharged
    2 (1 to 3)
    2 (1 to 4)
        No clinical status score reported - Discontinued
    3 (2 to 4)
    5 (3 to 7)
    No statistical analyses for this end point

    Secondary: Mortality

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    End point title
    Mortality
    End point description
    The mortality rate was estimated as the percentage of participants who died by study Day 29.
    End point type
    Secondary
    End point timeframe
    Entire trial (through day 29)
    End point values
    Placebo Remdesivir
    Number of subjects analysed
    521
    541
    Units: perc
        number (confidence interval 95%)
    15 (12 to 19)
    11 (9 to 15)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Days 1-29 (entire trial)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Normal saline given at equal volume on the same schedule

    Reporting group title
    Remdesivir
    Reporting group description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

    Serious adverse events
    Placebo Remdesivir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    163 / 516 (31.59%)
    131 / 532 (24.62%)
         number of deaths (all causes)
    77
    59
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    7 / 516 (1.36%)
    4 / 532 (0.75%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Shock
         subjects affected / exposed
    4 / 516 (0.78%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 516 (0.19%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Endotracheal intubation
         subjects affected / exposed
    9 / 516 (1.74%)
    6 / 532 (1.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ventilation
         subjects affected / exposed
    3 / 516 (0.58%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 516 (0.58%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Pyrexia
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    Hip fracture
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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 decreased
         subjects affected / exposed
    2 / 516 (0.39%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 516 (0.19%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         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
    7 / 516 (1.36%)
    10 / 532 (1.88%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    Atrial fibrillation
         subjects affected / exposed
    1 / 516 (0.19%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    3 / 516 (0.58%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    4 / 516 (0.78%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 516 (0.58%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 516 (0.00%)
    2 / 532 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 516 (0.19%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 516 (0.19%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    2 / 516 (0.39%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Palpitations
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    58 / 516 (11.24%)
    35 / 532 (6.58%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 36
         deaths causally related to treatment / all
    0 / 28
    0 / 20
    Acute respiratory failure
         subjects affected / exposed
    14 / 516 (2.71%)
    8 / 532 (1.50%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    Respiratory distress
         subjects affected / exposed
    11 / 516 (2.13%)
    6 / 532 (1.13%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    5 / 516 (0.97%)
    7 / 532 (1.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Pneumothorax
         subjects affected / exposed
    5 / 516 (0.97%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 516 (0.78%)
    5 / 532 (0.94%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Hypoxia
         subjects affected / exposed
    4 / 516 (0.78%)
    4 / 532 (0.75%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    2 / 516 (0.39%)
    4 / 532 (0.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Dyspnoea
         subjects affected / exposed
    1 / 516 (0.19%)
    3 / 532 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    2 / 516 (0.39%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    Cerebrovascular accident
         subjects affected / exposed
    1 / 516 (0.19%)
    3 / 532 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 516 (0.19%)
    2 / 532 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intensive care unit acquired weakness
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    0 / 516 (0.00%)
    3 / 532 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Diarrhoea
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematemesis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    12 / 516 (2.33%)
    7 / 532 (1.32%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    5 / 516 (0.97%)
    2 / 532 (0.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    3 / 516 (0.58%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         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
    Pain in extremity
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    Acidosis
         subjects affected / exposed
    1 / 516 (0.19%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    15 / 516 (2.91%)
    8 / 532 (1.50%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 8
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    COVID-19
         subjects affected / exposed
    5 / 516 (0.97%)
    2 / 532 (0.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Bacteraemia
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Sepsis
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 516 (0.39%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter bacteraemia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 532 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 532 (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
    Placebo Remdesivir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    295 / 516 (57.17%)
    276 / 532 (51.88%)
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    74 / 516 (14.34%)
    55 / 532 (10.34%)
         occurrences all number
    81
    59
    Haemoglobin decreased
         subjects affected / exposed
    62 / 516 (12.02%)
    48 / 532 (9.02%)
         occurrences all number
    69
    51
    Lymphocyte count decreased
         subjects affected / exposed
    54 / 516 (10.47%)
    44 / 532 (8.27%)
         occurrences all number
    63
    56
    Blood creatinine increased
         subjects affected / exposed
    36 / 516 (6.98%)
    31 / 532 (5.83%)
         occurrences all number
    41
    33
    Blood glucose increased
         subjects affected / exposed
    27 / 516 (5.23%)
    39 / 532 (7.33%)
         occurrences all number
    31
    45
    Aspartate aminotransferase increased
         subjects affected / exposed
    33 / 516 (6.40%)
    18 / 532 (3.38%)
         occurrences all number
    35
    19
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    52 / 516 (10.08%)
    42 / 532 (7.89%)
         occurrences all number
    58
    52
    Lymphopenia
         subjects affected / exposed
    30 / 516 (5.81%)
    13 / 532 (2.44%)
         occurrences all number
    34
    15
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    32 / 516 (6.20%)
    38 / 532 (7.14%)
         occurrences all number
    37
    52
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    34 / 516 (6.59%)
    34 / 532 (6.39%)
         occurrences all number
    43
    36

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2020
    After remdesivir was shown to be effective in ACTT-1, this platform protocol was amended to ACTT-2, which compared baricitanib vs. placebo on a background of remdesivir as standard of care. The results of ACTT-2 are reported in an attachment.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/32445440
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