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    Clinical Trial Results:
    A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19

    Summary
    EudraCT number
    		 2020-005395-35
    Trial protocol
    		 GB  
    Global end of trial date
    29 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Nov 2021
    First version publication date
    15 Oct 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Add clarity and correct units of measure.

    Trial information

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    Trial identification
    Sponsor protocol code
    Gates MRI - COD-01-T01-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04504032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bill & Melinda Gates Medical Research Institute
    Sponsor organisation address
    One Kendall Square, Building 600, Suite 6-301 Cambridge, United States, MA 02139
    Public contact
    Study Director, Bill & Melinda Gates Medical Research Institute, +1 857 702 2108, clinical.trials@gatesmri.org
    Scientific contact
    Study Director, Bill & Melinda Gates Medical Research Institute, +1 857 702 2108, clinical.trials@gatesmri.org
    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
    29 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.
    Protection of trial subjects
    The study was conducted in full compliance with the principles of the "Declaration of Helsinki" (as amended in Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonisation (ICH) guidelines, and all of the applicable requirements of the United States Code of Federal Regulations (US CFR), 21 CFR Part 50 & 312.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 497
    Worldwide total number of subjects
    497
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    427
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 538 participants were screened of which only 497 were randomized to treatment.

    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
    		 Investigator, Assessor, Data analyst, Subject
    Blinding implementation details
    The sponsor had installed a proper firewall to ensure that blinded individuals were insulated from knowledge of unblinded interim results.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rivaroxaban
    Arm description
    		 Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.

    Arm title
    		 Placebo
    Arm description
    		 Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.

    Number of subjects in period 1
    		Rivaroxaban Placebo
    Started
    246
    251
    Completed
    210
    223
    Not completed
    36
    28
         Consent withdrawn by subject
    9
    11
         Progressed To Moderate/Severe COVID-19
    1
    -
         Study Terminated By Sponsor
    1
    2
         Adverse event, non-fatal
    1
    2
         Disease Progression Prior To Dosing
    15
    3
         Lost to follow-up
    6
    9
         Drug Supply Issues
    1
    1
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.

    Reporting group values
    		 Rivaroxaban Placebo Total
    Number of subjects
    		 246 251 497
    Age categorical
    Units:
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.8 ( 12.28 ) 48.6 ( 12.14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 140 159 299
        Male
    		 106 92 198
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 49 46 95
        Not Hispanic or Latino
    		 197 201 398
        Unknown or Not Reported
    		 0 4 4
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 0 1 1
        Black or African American
    		 17 19 36
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 219 222 441
        Mixed race
    		 0 0 0
        Other
    		 7 7 14
        Unknown
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.

    Primary: Number of Participants with Grade 3 and Grade 4 Adverse Events (AEs) through Day 35

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    End point title
    		 Number of Participants with Grade 3 and Grade 4 Adverse Events (AEs) through Day 35 [1]
    End point description
    An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of a new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. AE severity was graded as Grade 3 (Severe) and Grade 4 (Potentially Life-threatening) per the specific toxicity grading by the Division of Acquired Immunodeficiency Syndrome (DAIDS) AE Grading Table.
    End point type
    Primary
    End point timeframe
    Up to Day 35
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary end point.
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    219
    230
    Units: Participants
        number (not applicable)
    6
    13
    No statistical analyses for this end point

    Primary: Number of Participants with AEs resulting in study intervention discontinuation through Day 35

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    End point title
    		 Number of Participants with AEs resulting in study intervention discontinuation through Day 35 [2]
    End point description
    An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions.
    End point type
    Primary
    End point timeframe
    Up to Day 35
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary end point.
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    219
    230
    Units: Participants
        number (not applicable)
    4
    5
    No statistical analyses for this end point

    Primary: Number of Participants with Serious Adverse Events through Day 35

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    End point title
    		 Number of Participants with Serious Adverse Events through Day 35 [3]
    End point description
    A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is an important medical event that 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.
    End point type
    Primary
    End point timeframe
    Up to Day 35
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary end point.
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    219
    230
    Units: Participants
        number (not applicable)
    2
    7
    No statistical analyses for this end point

    Primary: Number of participants who progressed to moderate or severe disease or higher based on the Gates MRI ordinal scale through Day 28

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    End point title
    		 Number of participants who progressed to moderate or severe disease or higher based on the Gates MRI ordinal scale through Day 28 [4]
    End point description
    Participants who progressed to a moderate or severe disease category or higher (Bill & Melinda Gates Medical Research Institute [Gates MRI] ordinal scale ≥3) are reported. Gates MRI scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with Extra-Corporeal Membrane Oxygenation (ECMO); 7=Death.
    End point type
    Primary
    End point timeframe
    Up to Day 28
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary end point.
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
        number (not applicable)
    46
    44
    No statistical analyses for this end point

    Secondary: Median time to disease resolution based on symptoms resolution through Day 28

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    End point title
    		 Median time to disease resolution based on symptoms resolution through Day 28
    End point description
    Time to disease resolution is defined as the time from the first dose to the date of symptoms resolution (new-onset Coronavirus Disease 2019 [COVID-19] symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% confidence interval (CI) for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    132
    122
    Units: Days
        median (confidence interval 95%)
    21.0 (19.0 to 23.0)
    23.0 (20.0 to 27.0)
    No statistical analyses for this end point

    Secondary: Median time to disease resolution based on viral clearance and symptoms resolution through Day 28

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    End point title
    		 Median time to disease resolution based on viral clearance and symptoms resolution through Day 28
    End point description
    Time to disease resolution is defined as the time from the first dose to the date of both viral clearance (two consecutive negative diagnostic tests) and symptoms resolution (new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% CI for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    125
    115
    Units: Days
        median (confidence interval 95%)
    23.0 (21.0 to 26.0)
    26.0 (22.0 to 28.0)
    No statistical analyses for this end point

    Secondary: Number of participants who progressed to moderate or severe disease or higher based on the Gates MRI ordinal scale at Day 8, 14, and 21

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    End point title
    		 Number of participants who progressed to moderate or severe disease or higher based on the Gates MRI ordinal scale at Day 8, 14, and 21
    End point description
    Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, and 21
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8
    38
    36
        Day 14
    44
    40
        Day 21
    45
    42
    No statistical analyses for this end point

    Secondary: Number of participants who achieved disease resolution based on symptoms resolution at Days 8, 14, 21, and 28

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    End point title
    		 Number of participants who achieved disease resolution based on symptoms resolution at Days 8, 14, 21, and 28
    End point description
    Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8
    26
    30
        Day 14
    64
    59
        Day 21
    100
    93
        Day 28
    132
    122
    No statistical analyses for this end point

    Secondary: Number of participants who achieved disease resolution based on viral clearance and symptoms resolution at Days 8, 14, 21, and 28

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    End point title
    		 Number of participants who achieved disease resolution based on viral clearance and symptoms resolution at Days 8, 14, 21, and 28
    End point description
    Viral clearance is defined as two consecutive negative diagnostic tests. Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8
    12
    20
        Day 14
    49
    44
        Day 21
    86
    83
        Day 28
    125
    115
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Gates Medical Research Institute (MRI) scale clinical status at Days 8, 14, 21, and 28

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    End point title
    		 Number of participants with the indicated Gates Medical Research Institute (MRI) scale clinical status at Days 8, 14, 21, and 28
    End point description
    Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8: Score 1
    33
    31
        Day 8: Score 2
    152
    159
        Day 8: Score 3
    3
    8
        Day 8: Score 4
    0
    0
        Day 8: Score 5
    0
    0
        Day 8: Score 6
    0
    0
        Day 8: Score 7
    0
    0
        Day 14: Score 1
    69
    55
        Day 14: Score 2
    114
    132
        Day 14: Score 3
    3
    7
        Day 14: Score 4
    0
    0
        Day 14: Score 5
    0
    0
        Day 14: Score 6
    0
    0
        Day 14: Score 7
    0
    0
        Day 21: Score 1
    98
    79
        Day 21: Score 2
    87
    109
        Day 21: Score 3
    1
    5
        Day 21: Score 4
    0
    0
        Day 21: Score 5
    0
    0
        Day 21: Score 6
    0
    0
        Day 21: Score 7
    0
    0
        Day 28: Score 1
    125
    108
        Day 28: Score 2
    57
    81
        Day 28: Score 3
    1
    4
        Day 28: Score 4
    0
    0
        Day 28: Score 5
    0
    0
        Day 28: Score 6
    0
    0
        Day 28: Score 7
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated World Health Organization (WHO) ordinal scale clinical status at Days 8, 14, 21, and 28

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    End point title
    		 Number of participants with the indicated World Health Organization (WHO) ordinal scale clinical status at Days 8, 14, 21, and 28
    End point description
    The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO; 10=Dead.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8: Score 0
    19
    19
        Day 8: Score 1
    14
    12
        Day 8: Score 2
    154
    166
        Day 8: Score 3
    0
    1
        Day 8: Score 4
    1
    0
        Day 8: Score 5
    0
    0
        Day 8: Score 6
    0
    0
        Day 8: Score 7
    0
    0
        Day 8: Score 8
    0
    0
        Day 8: Score 9
    0
    0
        Day 8: Score 10
    0
    0
        Day 14: Score 0
    56
    40
        Day 14: Score 1
    15
    16
        Day 14: Score 2
    115
    137
        Day 14: Score 3
    0
    1
        Day 14: Score 4
    0
    0
        Day 14: Score 5
    0
    0
        Day 14: Score 6
    0
    0
        Day 14: Score 7
    0
    0
        Day 14: Score 8
    0
    0
        Day 14: Score 9
    0
    0
        Day 14: Score 10
    0
    0
        Day 21: Score 0
    87
    72
        Day 21: Score 1
    12
    8
        Day 21: Score 2
    87
    112
        Day 21: Score 3
    0
    1
        Day 21: Score 4
    0
    0
        Day 21: Score 5
    0
    0
        Day 21: Score 6
    0
    0
        Day 21: Score 7
    0
    0
        Day 21: Score 8
    0
    0
        Day 21: Score 9
    0
    0
        Day 21: Score 10
    0
    0
        Day 28: Score 0
    117
    106
        Day 28: Score 1
    9
    4
        Day 28: Score 2
    57
    82
        Day 28: Score 3
    0
    1
        Day 28: Score 4
    0
    0
        Day 28: Score 5
    0
    0
        Day 28: Score 6
    0
    0
        Day 28: Score 7
    0
    0
        Day 28: Score 8
    0
    0
        Day 28: Score 9
    0
    0
        Day 28: Score 10
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with hospitalization through Days 8, 14, 21, and 28

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    End point title
    		 Number of participants with hospitalization through Days 8, 14, 21, and 28
    End point description
    Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Up to Day 8
    3
    6
        Up to Day 14
    3
    7
        Up to Day 21
    3
    7
        Up to Day 28
    3
    7
    No statistical analyses for this end point

    Secondary: Median number of days of hospitalization through Day 35

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    End point title
    		 Median number of days of hospitalization through Day 35
    End point description
    Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. Hospitalized participants without an end date of hospitalization were not included.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Days
        median (full range (min-max))
    5.0 (4.0 to 5.0)
    4.0 (2.0 to 30.0)
    No statistical analyses for this end point

    Secondary: Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28

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    End point title
    		 Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28
    End point description
    Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. BS= Baseline; PBS= Post-Baseline; NA= Data not available.
    End point type
    Secondary
    End point timeframe
    Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8: shift from BS score 1 to PBS score 1
    2
    1
        Day 8: shift from BS score 1 to PBS score 2
    0
    0
        Day 8: shift from BS score 1 to PBS score 3
    0
    0
        Day 8: shift from BS score 1 to PBS score >=4
    0
    0
        Day 8: shift from BS score 1 to PBS score NA
    0
    0
        Day 8: shift from BS score 2 to PBS score 1
    31
    30
        Day 8: shift from BS score 2 to PBS score 2
    152
    158
        Day 8: shift from BS score 2 to PBS score 3
    3
    8
        Day 8: shift from BS score 2 to PBS score >=4
    0
    0
        Day 8: shift from BS score 2 to PBS score NA
    7
    4
        Day 8: shift from BS score 3 to PBS score 1
    0
    0
        Day 8: shift from BS score 3 to PBS score 2
    0
    0
        Day 8: shift from BS score 3 to PBS score 3
    0
    0
        Day 8: shift from BS score 3 to PBS score >=4
    0
    0
        Day 8: shift from BS score 3 to PBS score NA
    12
    3
        Day 8: shift from BS score NA to PBS score 1
    0
    0
        Day 8: shift from BS score NA to PBS score 2
    0
    0
        Day 8: shift from BS score NA to PBS score 3
    0
    0
        Day 8: shift from BS score NA to PBS score >=4
    0
    0
        Day 8: shift from BS score NA to PBS score NA
    15
    17
        Day 14: shift from BS score 1 to PBS score 1
    2
    1
        Day 14: shift from BS score 1 to PBS score 2
    0
    0
        Day 14: shift from BS score 1 to PBS score 3
    0
    0
        Day 14: shift from BS score 1 to PBS score >=4
    0
    0
        Day 14: shift from BS score 1 to PBS score NA
    0
    0
        Day 14: shift from BS score 2 to PBS score 1
    67
    54
        Day 14: shift from BS score 2 to PBS score 2
    114
    131
        Day 14: shift from BS score 2 to PBS score 3
    3
    7
        Day 14: shift from BS score 2 to PBS score >=4
    0
    0
        Day 14: shift from BS score 2 to PBS score NA
    9
    8
        Day 14: shift from BS score 3 to PBS score 1
    0
    0
        Day 14: shift from BS score 3 to PBS score 2
    0
    1
        Day 14: shift from BS score 3 to PBS score 3
    0
    0
        Day 14: shift from BS score 3 to PBS score >=4
    0
    0
        Day 14: shift from BS score 3 to PBS score NA
    12
    3
        Day 14: shift from BS score NA to PBS score 1
    0
    0
        Day 14: shift from BS score NA to PBS score 2
    0
    0
        Day 14: shift from BS score NA to PBS score 3
    0
    0
        Day 14: shift from BS score NA to PBS score >=4
    0
    0
        Day 14: shift from BS score NA to PBS score NA
    15
    17
        Day 21: shift from BS score 1 to PBS score 1
    2
    0
        Day 21: shift from BS score 1 to PBS score 2
    0
    0
        Day 21: shift from BS score 1 to PBS score 3
    0
    0
        Day 21: shift from BS score 1 to PBS score >=4
    0
    0
        Day 21: shift from BS score 1 to PBS score NA
    0
    1
        Day 21: shift from BS score 2 to PBS score 1
    96
    78
        Day 21: shift from BS score 2 to PBS score 2
    87
    109
        Day 21: shift from BS score 2 to PBS score 3
    1
    5
        Day 21: shift from BS score 2 to PBS score >=4
    0
    0
        Day 21: shift from BS score 2 to PBS score NA
    9
    8
        Day 21: shift from BS score 3 to PBS score 1
    0
    1
        Day 21: shift from BS score 3 to PBS score 2
    0
    0
        Day 21: shift from BS score 3 to PBS score 3
    0
    0
        Day 21: shift from BS score 3 to PBS score >=4
    0
    0
        Day 21: shift from BS score 3 to PBS score NA
    12
    3
        Day 21: shift from BS score NA to PBS score 1
    0
    0
        Day 21: shift from BS score NA to PBS score 2
    0
    0
        Day 21: shift from BS score NA to PBS score 3
    0
    0
        Day 21: shift from BS score NA to PBS score >=4
    0
    0
        Day 21: shift from BS score NA to PBS score NA
    15
    17
        Day 28: shift from BS score 1 to PBS score 1
    2
    1
        Day 28: shift from BS score 1 to PBS score 2
    0
    0
        Day 28: shift from BS score 1 to PBS score 3
    0
    0
        Day 28: shift from BS score 1 to PBS score >=4
    0
    0
        Day 28: shift from BS score 1 to PBS score NA
    0
    0
        Day 28: shift from BS score 2 to PBS score 1
    123
    106
        Day 28: shift from BS score 2 to PBS score 2
    57
    81
        Day 28: shift from BS score 2 to PBS score 3
    1
    4
        Day 28: shift from BS score 2 to PBS score >=4
    0
    0
        Day 28: shift from BS score 2 to PBS score NA
    12
    9
        Day 28: shift from BS score 3 to PBS score 1
    0
    1
        Day 28: shift from BS score 3 to PBS score 2
    0
    0
        Day 28: shift from BS score 3 to PBS score 3
    0
    0
        Day 28: shift from BS score 3 to PBS score >=4
    0
    0
        Day 28: shift from BS score 3 to PBS score NA
    12
    3
        Day 28: shift from BS score NA to PBS score 1
    0
    0
        Day 28: shift from BS score NA to PBS score 2
    0
    0
        Day 28: shift from BS score NA to PBS score 3
    0
    0
        Day 28: shift from BS score NA to PBS score >=4
    0
    0
        Day 28: shift from BS score NA to PBS score NA
    15
    17
    No statistical analyses for this end point

    Secondary: Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28

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    End point title
    		 Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28
    End point description
    The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO; 10=Dead. BS= Baseline; PBS= Post-Baseline; NA= Data not available.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    222
    222
    Units: Participants
    number (not applicable)
        Day 8: shift from BS score 0 to PBS score 0
    2
    0
        Day 8: shift from BS score 0 to PBS score 1
    0
    0
        Day 8: shift from BS score 0 to PBS score 2
    0
    0
        Day 8: shift from BS score 0 to PBS score 3
    0
    0
        Day 8: shift from BS score 0 to PBS score 4
    0
    0
        Day 8: shift from BS score 0 to PBS score 5
    0
    0
        Day 8: shift from BS score 0 to PBS score >=6
    0
    0
        Day 8: shift from BS score 0 to PBS score NA
    0
    0
        Day 8: shift from BS score 1 to PBS score 0
    0
    1
        Day 8: shift from BS score 1 to PBS score 1
    0
    0
        Day 8: shift from BS score 1 to PBS score 2
    0
    0
        Day 8: shift from BS score 1 to PBS score 3
    0
    0
        Day 8: shift from BS score 1 to PBS score 4
    0
    0
        Day 8: shift from BS score 1 to PBS score 5
    0
    0
        Day 8: shift from BS score 1 to PBS score >=6
    0
    0
        Day 8: shift from BS score 1 to PBS score NA
    0
    0
        Day 8: shift from BS score 2 to PBS score 0
    17
    18
        Day 8: shift from BS score 2 to PBS score 1
    14
    12
        Day 8: shift from BS score 2 to PBS score 2
    154
    166
        Day 8: shift from BS score 2 to PBS score 3
    0
    1
        Day 8: shift from BS score 2 to PBS score 4
    1
    0
        Day 8: shift from BS score 2 to PBS score 5
    0
    0
        Day 8: shift from BS score 2 to PBS score >=6
    0
    0
        Day 8: shift from BS score 2 to PBS score NA
    18
    7
        Day 8: shift from BS score 3 to PBS score 0
    0
    0
        Day 8: shift from BS score 3 to PBS score 1
    0
    0
        Day 8: shift from BS score 3 to PBS score 2
    0
    0
        Day 8: shift from BS score 3 to PBS score 3
    0
    0
        Day 8: shift from BS score 3 to PBS score 4
    0
    0
        Day 8: shift from BS score 3 to PBS score 5
    0
    0
        Day 8: shift from BS score 3 to PBS score >=6
    0
    0
        Day 8: shift from BS score 3 to PBS score NA
    1
    0
        Day 8: shift from BS score NA to PBS score 0
    0
    0
        Day 8: shift from BS score NA to PBS score 1
    0
    0
        Day 8: shift from BS score NA to PBS score 2
    0
    0
        Day 8: shift from BS score NA to PBS score 3
    0
    0
        Day 8: shift from BS score NA to PBS score 4
    0
    0
        Day 8: shift from BS score NA to PBS score 5
    0
    0
        Day 8: shift from BS score NA to PBS score >=6
    0
    0
        Day 8: shift from BS score NA to PBS score NA
    15
    17
        Day 14: shift from BS score 0 to PBS score 0
    2
    0
        Day 14: shift from BS score 0 to PBS score 1
    0
    0
        Day 14: shift from BS score 0 to PBS score 2
    0
    0
        Day 14: shift from BS score 0 to PBS score 3
    0
    0
        Day 14: shift from BS score 0 to PBS score 4
    0
    0
        Day 14: shift from BS score 0 to PBS score 5
    0
    0
        Day 14: shift from BS score 0 to PBS score >=6
    0
    0
        Day 14: shift from BS score 0 to PBS score NA
    0
    0
        Day 14: shift from BS score 1 to PBS score 0
    0
    1
        Day 14: shift from BS score 1 to PBS score 1
    0
    0
        Day 14: shift from BS score 1 to PBS score 2
    0
    0
        Day 14: shift from BS score 1 to PBS score 3
    0
    0
        Day 14: shift from BS score 1 to PBS score 4
    0
    0
        Day 14: shift from BS score 1 to PBS score 5
    0
    0
        Day 14: shift from BS score 1 to PBS score >=6
    0
    0
        Day 14: shift from BS score 1 to PBS score NA
    0
    0
        Day 14: shift from BS score 2 to PBS score 0
    54
    39
        Day 14: shift from BS score 2 to PBS score 1
    15
    16
        Day 14: shift from BS score 2 to PBS score 2
    115
    137
        Day 14: shift from BS score 2 to PBS score 3
    0
    1
        Day 14: shift from BS score 2 to PBS score 4
    0
    0
        Day 14: shift from BS score 2 to PBS score 5
    0
    0
        Day 14: shift from BS score 2 to PBS score >=6
    0
    0
        Day 14: shift from BS score 2 to PBS score NA
    20
    11
        Day 14: shift from BS score 3 to PBS score 0
    0
    0
        Day 14: shift from BS score 3 to PBS score 1
    0
    0
        Day 14: shift from BS score 3 to PBS score 2
    0
    0
        Day 14: shift from BS score 3 to PBS score 3
    0
    0
        Day 14: shift from BS score 3 to PBS score 4
    0
    0
        Day 14: shift from BS score 3 to PBS score 5
    0
    0
        Day 14: shift from BS score 3 to PBS score >=6
    0
    0
        Day 14: shift from BS score 3 to PBS score NA
    1
    0
        Day 14: shift from BS score NA to PBS score 0
    0
    0
        Day 14: shift from BS score NA to PBS score 1
    0
    0
        Day 14: shift from BS score NA to PBS score 2
    0
    0
        Day 14: shift from BS score NA to PBS score 3
    0
    0
        Day 14: shift from BS score NA to PBS score 4
    0
    0
        Day 14: shift from BS score NA to PBS score 5
    0
    0
        Day 14: shift from BS score NA to PBS score >=6
    0
    0
        Day 14: shift from BS score NA to PBS score NA
    15
    17
        Day 21: shift from BS score 0 to PBS score 0
    2
    0
        Day 21: shift from BS score 0 to PBS score 1
    0
    0
        Day 21: shift from BS score 0 to PBS score 2
    0
    0
        Day 21: shift from BS score 0 to PBS score 3
    0
    0
        Day 21: shift from BS score 0 to PBS score 4
    0
    0
        Day 21: shift from BS score 0 to PBS score 5
    0
    0
        Day 21: shift from BS score 0 to PBS score >=6
    0
    0
        Day 21: shift from BS score 0 to PBS score NA
    0
    0
        Day 21: shift from BS score 1 to PBS score 0
    0
    0
        Day 21: shift from BS score 1 to PBS score 1
    0
    0
        Day 21: shift from BS score 1 to PBS score 2
    0
    0
        Day 21: shift from BS score 1 to PBS score 3
    0
    0
        Day 21: shift from BS score 1 to PBS score 4
    0
    0
        Day 21: shift from BS score 1 to PBS score 5
    0
    0
        Day 21: shift from BS score 1 to PBS score >=6
    0
    0
        Day 21: shift from BS score 1 to PBS score NA
    0
    1
        Day 21: shift from BS score 2 to PBS score 0
    85
    72
        Day 21: shift from BS score 2 to PBS score 1
    12
    8
        Day 21: shift from BS score 2 to PBS score 2
    87
    112
        Day 21: shift from BS score 2 to PBS score 3
    0
    1
        Day 21: shift from BS score 2 to PBS score 4
    0
    0
        Day 21: shift from BS score 2 to PBS score 5
    0
    0
        Day 21: shift from BS score 2 to PBS score >=6
    0
    0
        Day 21: shift from BS score 2 to PBS score NA
    20
    11
        Day 21: shift from BS score 3 to PBS score 0
    0
    0
        Day 21: shift from BS score 3 to PBS score 1
    0
    0
        Day 21: shift from BS score 3 to PBS score 2
    0
    0
        Day 21: shift from BS score 3 to PBS score 3
    0
    0
        Day 21: shift from BS score 3 to PBS score 4
    0
    0
        Day 21: shift from BS score 3 to PBS score 5
    0
    0
        Day 21: shift from BS score 3 to PBS score >=6
    0
    0
        Day 21: shift from BS score 3 to PBS score NA
    1
    0
        Day 21: shift from BS score NA to PBS score 0
    0
    0
        Day 21: shift from BS score NA to PBS score 1
    0
    0
        Day 21: shift from BS score NA to PBS score 2
    0
    0
        Day 21: shift from BS score NA to PBS score 3
    0
    0
        Day 21: shift from BS score NA to PBS score 4
    0
    0
        Day 21: shift from BS score NA to PBS score 5
    0
    0
        Day 21: shift from BS score NA to PBS score >=6
    0
    0
        Day 21: shift from BS score NA to PBS score NA
    15
    17
        Day 28: shift from BS score 0 to PBS score 0
    2
    0
        Day 28: shift from BS score 0 to PBS score 1
    0
    0
        Day 28: shift from BS score 0 to PBS score 2
    0
    0
        Day 28: shift from BS score 0 to PBS score 3
    0
    0
        Day 28: shift from BS score 0 to PBS score 4
    0
    0
        Day 28: shift from BS score 0 to PBS score 5
    0
    0
        Day 28: shift from BS score 0 to PBS score >=6
    0
    0
        Day 28: shift from BS score 0 to PBS score NA
    0
    0
        Day 28: shift from BS score 1 to PBS score 0
    0
    1
        Day 28: shift from BS score 1 to PBS score 1
    0
    0
        Day 28: shift from BS score 1 to PBS score 2
    0
    0
        Day 28: shift from BS score 1 to PBS score 3
    0
    0
        Day 28: shift from BS score 1 to PBS score 4
    0
    0
        Day 28: shift from BS score 1 to PBS score 5
    0
    0
        Day 28: shift from BS score 1 to PBS score >=6
    0
    0
        Day 28: shift from BS score 1 to PBS score NA
    0
    0
        Day 28: shift from BS score 2 to PBS score 0
    115
    105
        Day 28: shift from BS score 2 to PBS score 1
    9
    4
        Day 28: shift from BS score 2 to PBS score 2
    57
    82
        Day 28: shift from BS score 2 to PBS score 3
    0
    1
        Day 28: shift from BS score 2 to PBS score 4
    0
    0
        Day 28: shift from BS score 2 to PBS score 5
    0
    0
        Day 28: shift from BS score 2 to PBS score >=6
    0
    0
        Day 28: shift from BS score 2 to PBS score NA
    23
    12
        Day 28: shift from BS score 3 to PBS score 0
    0
    0
        Day 28: shift from BS score 3 to PBS score 1
    0
    0
        Day 28: shift from BS score 3 to PBS score 2
    0
    0
        Day 28: shift from BS score 3 to PBS score 3
    0
    0
        Day 28: shift from BS score 3 to PBS score 4
    0
    0
        Day 28: shift from BS score 3 to PBS score 5
    0
    0
        Day 28: shift from BS score 3 to PBS score >=6
    0
    0
        Day 28: shift from BS score 3 to PBS score NA
    1
    0
        Day 28: shift from BS score NA to PBS score 0
    0
    0
        Day 28: shift from BS score NA to PBS score 1
    0
    0
        Day 28: shift from BS score NA to PBS score 2
    0
    0
        Day 28: shift from BS score NA to PBS score 3
    0
    0
        Day 28: shift from BS score NA to PBS score 4
    0
    0
        Day 28: shift from BS score NA to PBS score 5
    0
    0
        Day 28: shift from BS score NA to PBS score >=6
    0
    0
        Day 28: shift from BS score NA to PBS score NA
    15
    17
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28

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    End point title
    		 Change From Baseline in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28
    End point description
    Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre- COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 14. Change from Baseline could not be calculated because data for later timepoints was not collected.
    End point type
    Other pre-specified
    End point timeframe
    Baseline; Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [5] - No subjects were analyzed
    [6] - No subjects were analyzed
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28

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    End point title
    		 Change From Baseline in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28
    End point description
    WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO; 10=Dead. Instead of change from baseline, shift in scores from baseline was measured and have been presented in outcome measure 16. Change from Baseline couldn't be calculated because data for later timepoints was not collected.
    End point type
    Other pre-specified
    End point timeframe
    Baseline; Days 8, 14, 21, and 28
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [7] - No subjects were analyzed
    [8] - No subjects were analyzed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of consent up to 14 days after the last dose of study treatment (Day 35).
    Adverse event reporting additional description
    Analysis was performed in the Safety Population, comprised of all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.

    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Participants self-administered rivaroxaban 10 milligrams (mg) (1 tablet) orally once daily for 21 days.

    Serious adverse events
    		 Placebo Rivaroxaban
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 230 (3.04%)
    2 / 219 (0.91%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute kidney injury
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 219 (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
    COVID-19 pneumonia
         subjects affected / exposed
    4 / 230 (1.74%)
    2 / 219 (0.91%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo Rivaroxaban
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 230 (4.78%)
    12 / 219 (5.48%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 230 (1.74%)
    3 / 219 (1.37%)
         occurrences all number
    4
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    3 / 230 (1.30%)
    1 / 219 (0.46%)
         occurrences all number
    3
    1
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    0 / 230 (0.00%)
    3 / 219 (1.37%)
         occurrences all number
    0
    3
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    0 / 230 (0.00%)
    4 / 219 (1.83%)
         occurrences all number
    0
    4
    COVID -19/COVID-19 pneumonia/pneumonia
         subjects affected / exposed
    5 / 230 (2.17%)
    1 / 219 (0.46%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2020
    By means of Amendment 1, emergent and important issues at clinical sites pertaining to screening and enrollment were addressed. These included: (1) the requirement for screening to occur within 72 hours of symptom onset resulted in many potential subjects who had symptoms onset before 72 hours being excluded from consideration for enrollment; and (2) the requirement for Day 1 to occur no later than 72 hours after screening did not take into account the time required to obtain SARS-CoV-2 test results (for subjects not having documentation of a prior positive test) nor the time needed to provide study materials to subjects once randomization had occurred. The time constraints described above restricted enrollment and the study team decided that both constraints needed to be relaxed to enable efficient enrollment. Amendment 1 implemented the changes that subjects had to have documented positive SARS-CoV-2 diagnostic testing with a sample collected ≤ 10 days before screening and had to be symptomatic for COVID-19 for ≤ 7 days at time of randomization. It also implemented that screening procedures had to occur ≤ 5 days prior to the Day 1 visit. Because the putative effect of rivaroxaban to prevent thrombotic complications of COVID-19 would be present during the whole of the treatment period, the expansion of the intervals as detailed above were not anticipated to significantly impact the results of the study.
    27 Jan 2021
    By means of Amendment 2, the protocol was amended to reduce the number of interim analyses from 3 to 1 and to remove the sample size re-estimation procedure. Additional changes included modifying the first interim analysis from an evaluation of futility and efficacy to be limited to futility, and to remove any additional pre-specified interim analyses. These changes were made since the pace and trajectory of study enrollment suggested that the targeted number of total study subjects (600) would be met by the time of the proposed data cut for the second planned interim analysis, and that the majority of study subjects would have completed the study by the time of the planned IDMC meeting. Therefore, any decision stemming from the proposed second interim analysis would have been unlikely to affect the study conduct.

    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.
    Based on Data Monitoring Committee's recommendation on February 3, 2021, the study was stopped due to futility.
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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
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