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    Clinical Trial Results:
    A multicenter, randomized, active controlled, open label, platform trial on the efficacy and safety of experimental therapeutics for patients with COVID-19 (caused by infection with severe acute respiratory syndrome coronavirus-2) ACOVACT (Austrian CoronaVirus Adaptive Clinical Trial)

    Summary
    EudraCT number
    		 2020-001302-30
    Trial protocol
    		 AT  
    Global end of trial date
    03 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2023
    First version publication date
    19 Nov 2023
    Other versions
    Summary report(s)
    		 Adverse Events

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ACOVACT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    Sponsor, Medical University of Vienna, Department of Clinical Pharmacology, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Sponsor, Medical University of Vienna, Department of Clinical Pharmacology, klin-pharmakologie@meduniwien.ac.at
    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 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of various experimental therapeutics for patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); for efficacy assessment an ordinal scale for clinical severity assessment as proposed by the World Health Organization was used: Time to sustained improvement of one category from admission.
    Protection of trial subjects
    For “antiviral” treatment arms and sub-studies only hospitalized patients were included and intake of medication was intensly controlled.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 345
    Worldwide total number of subjects
    345
    EEA total number of subjects
    345
    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)
    225
    From 65 to 84 years
    112
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were selected per study site from the pool of admitted patients. No extra recruitment strategies were necessary.

    Pre-assignment
    Screening details
    		 During the screening procedure the patients’ eligibility for each trial arm was checked. The main prerequisite was a laboratory or radiologically proven infection with SARS-CoV-2.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Main Study
    Arm description
    		 Main “antiviral therapy” study: Reporting group 1: Resochin/Quensyl Reporting group 2: Kaletra Reporting group 3: Veklury Reporting group 4: Standard of care (SOC) (“control arm” of the study)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Quensyl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg 2-0-2 Maintenance dose: 200 mg 1-0-1

    Investigational medicinal product name
    Kaletra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kaletra low-dose: Initial and maintenance dose: 200 mg/50 mg 2-0-2 Kaletra high-dose: Initial dose: 200 mg/50 mg 4-0-4, maintenance dose: 200mg/50mg 3-0-3

    Investigational medicinal product name
    Veklury
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Initial dose: 200mg/day Maintenance dose: 100mg/day

    Arm title
    		 Substudy A
    Arm description
    		 Subjects received Xarelto versus standard of care
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xarelto
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initial dose: 10 mg 1/2-0-1/2 Maintenance dose: down-titration allowed in case of high anti-FXa activity before the next dose

    Arm title
    		 Substudy B- Cohort 1
    Arm description
    		 • Stay on any RAS blockade: patients with previously known and treated hypertension (treatment according to standard of care). • Switch to non-RAS blocking agent: switch of patients with previously known and treated hypertension to non-RAS blocking agents (treatment according to standard of care, e.g. nitrendipine, amlodipine or doxazosin)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Substudy B- Cohort 2
    Arm description
    		 • Treatment with RAS blocking agent: treatment of patients with blood pressure >130/85mmHg in two consecutive measurements with RAS blocking agent candesartan (Blopress) • Non-RAS blocking agents: treatment according to standard of care, e.g. with nitrendipine, amlodipine or doxazosin, or no treatment, if blood pressure <140/90mmHg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Blopress
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Initial dose: candesartan 8 mg 1-0-0; Maintenance dose: Up-titration to normotension

    Arm title
    		 Substudy C - Asunercept
    Arm description
    		 • Asunercept randomized against standard of care (25 mg, 100 mg or 400 mg according to the respective randomized sub-arm)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Asunercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Initial dose: 25 mg, 100 mg or 400 mg once a week according to the respective randomized sub-arm. Maintenance dose: same as first dosage.

    Arm title
    		 Substudy C - Pentaglobin
    Arm description
    		 • Pentaglobin randomized against standard of care
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pentaglobin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Continuous i.v. application of a total dose of 7ml/kg/day Infusion over 12h

    Number of subjects in period 1
    		Main Study Substudy A Substudy B- Cohort 1 Substudy B- Cohort 2 Substudy C - Asunercept Substudy C - Pentaglobin
    Started
    224
    145
    60
    8
    102
    34
    Completed
    214
    140
    59
    7
    99
    32
    Not completed
    10
    5
    1
    1
    3
    2
         Own Request
    3
    2
    -
    -
    3
    -
         screening failure
    3
    1
    -
    1
    -
    1
         dropout
    4
    2
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Main Study
    Reporting group description
    		 Main “antiviral therapy” study: Reporting group 1: Resochin/Quensyl Reporting group 2: Kaletra Reporting group 3: Veklury Reporting group 4: Standard of care (SOC) (“control arm” of the study)

    Reporting group title
    Substudy A
    Reporting group description
    		 Subjects received Xarelto versus standard of care

    Reporting group title
    Substudy B- Cohort 1
    Reporting group description
    		 • Stay on any RAS blockade: patients with previously known and treated hypertension (treatment according to standard of care). • Switch to non-RAS blocking agent: switch of patients with previously known and treated hypertension to non-RAS blocking agents (treatment according to standard of care, e.g. nitrendipine, amlodipine or doxazosin)

    Reporting group title
    Substudy B- Cohort 2
    Reporting group description
    		 • Treatment with RAS blocking agent: treatment of patients with blood pressure >130/85mmHg in two consecutive measurements with RAS blocking agent candesartan (Blopress) • Non-RAS blocking agents: treatment according to standard of care, e.g. with nitrendipine, amlodipine or doxazosin, or no treatment, if blood pressure <140/90mmHg.

    Reporting group title
    Substudy C - Asunercept
    Reporting group description
    		 • Asunercept randomized against standard of care (25 mg, 100 mg or 400 mg according to the respective randomized sub-arm)

    Reporting group title
    Substudy C - Pentaglobin
    Reporting group description
    		 • Pentaglobin randomized against standard of care

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Arms were not mutually exclusive. Total number of enrolled subjects was 345.
    Reporting group values
    		 Main Study Substudy A Substudy B- Cohort 1 Substudy B- Cohort 2 Substudy C - Asunercept Substudy C - Pentaglobin Total
    Number of subjects
    		 224 145 60 8 102 34 345
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 144 102 28 7 63 30 225
        From 65-84 years
    		 75 38 32 1 36 4 112
        85 years and over
    		 5 5 0 0 3 0 8
    Gender categorical
    Units: Subjects
        Female
    		 72 45 23 0 29 8 104
        Male
    		 152 100 37 8 73 26 241
    Subject analysis sets

    Subject analysis set title
    Main study: Quensyl
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Quensyl.

    Subject analysis set title
    Main study: Kaletra
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Kaletra

    Subject analysis set title
    Main study: Veklury
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Veklury.

    Subject analysis set title
    Main study: Standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving standard of care.

    Subject analysis set title
    Substudy A: Xarelto
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Xarelto in substudy A.

    Subject analysis set title
    Substudy A: standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving standard of care in substudy A.

    Subject analysis set title
    Substudy B-Cohort 1 Stay on any RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with previously known and treated hypertension (treatment according to standard of care).

    Subject analysis set title
    Substudy B-Cohort 1 Switch to non RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with previously known and treated hypertension who switch to non-RAS blocking agents (treatment according to standard of care, e.g. nitrendipine, amlodipine or doxazosin)

    Subject analysis set title
    Substudy B-Cohort 2 Blopress
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with blood pressure >130/85mmHg in two consecutive measurements with treatment of RAS blocking agent candesartan (Blopress)

    Subject analysis set title
    Substudy B-Cohort 2 non RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects with treatment according to standard of care, e.g. with nitrendipine, amlodipine or doxazosin, or no treatment, if blood pressure <140/90mmHg.

    Subject analysis set title
    Substudy C- Asunercept high dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Asunercept high dose (400mg).

    Subject analysis set title
    Substudy C- Asunercept intermediate dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving for Asunercept intermedian dose (100mg).

    Subject analysis set title
    Substudy C- Asunercept low dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Asunercept low dose (25mg).

    Subject analysis set title
    Substudy C Asunercept standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving standard of care in substudy C Asunercept

    Subject analysis set title
    Substudy C Pentaglobin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Pentaglobin

    Subject analysis set title
    Substudy C Pentaglobin standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving standard of care in substudy C Pentaglobin

    Subject analysis sets values
    		 Main study: Quensyl Main study: Kaletra Main study: Veklury Main study: Standard of care Substudy A: Xarelto Substudy A: standard of care Substudy B-Cohort 1 Stay on any RAS Substudy B-Cohort 1 Switch to non RAS Substudy B-Cohort 2 Blopress Substudy B-Cohort 2 non RAS Substudy C- Asunercept high dose Substudy C- Asunercept intermediate dose Substudy C- Asunercept low dose Substudy C Asunercept standard of care Substudy C Pentaglobin Substudy C Pentaglobin standard of care
    Number of subjects
    11
    101
    2
    105
    70
    73
    32
    28
    3
    4
    25
    23
    26
    25
    17
    16
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    8
    60
    1
    72
    49
    52
    13
    15
    3
    3
    14
    14
    17
    16
    15
    14
        From 65-84 years
    3
    40
    1
    30
    17
    21
    19
    13
    0
    1
    8
    9
    9
    9
    2
    2
        85 years and over
    0
    1
    0
    3
    4
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    2
    33
    1
    34
    25
    19
    9
    14
    0
    0
    5
    6
    5
    13
    4
    4
        Male
    9
    68
    1
    71
    45
    54
    23
    14
    3
    4
    20
    17
    21
    12
    13
    12

    End points

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    End points reporting groups
    Reporting group title
    Main Study
    Reporting group description
    		 Main “antiviral therapy” study: Reporting group 1: Resochin/Quensyl Reporting group 2: Kaletra Reporting group 3: Veklury Reporting group 4: Standard of care (SOC) (“control arm” of the study)

    Reporting group title
    Substudy A
    Reporting group description
    		 Subjects received Xarelto versus standard of care

    Reporting group title
    Substudy B- Cohort 1
    Reporting group description
    		 • Stay on any RAS blockade: patients with previously known and treated hypertension (treatment according to standard of care). • Switch to non-RAS blocking agent: switch of patients with previously known and treated hypertension to non-RAS blocking agents (treatment according to standard of care, e.g. nitrendipine, amlodipine or doxazosin)

    Reporting group title
    Substudy B- Cohort 2
    Reporting group description
    		 • Treatment with RAS blocking agent: treatment of patients with blood pressure >130/85mmHg in two consecutive measurements with RAS blocking agent candesartan (Blopress) • Non-RAS blocking agents: treatment according to standard of care, e.g. with nitrendipine, amlodipine or doxazosin, or no treatment, if blood pressure <140/90mmHg.

    Reporting group title
    Substudy C - Asunercept
    Reporting group description
    		 • Asunercept randomized against standard of care (25 mg, 100 mg or 400 mg according to the respective randomized sub-arm)

    Reporting group title
    Substudy C - Pentaglobin
    Reporting group description
    		 • Pentaglobin randomized against standard of care

    Subject analysis set title
    Main study: Quensyl
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Quensyl.

    Subject analysis set title
    Main study: Kaletra
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Kaletra

    Subject analysis set title
    Main study: Veklury
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Veklury.

    Subject analysis set title
    Main study: Standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving standard of care.

    Subject analysis set title
    Substudy A: Xarelto
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving Xarelto in substudy A.

    Subject analysis set title
    Substudy A: standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects receiving standard of care in substudy A.

    Subject analysis set title
    Substudy B-Cohort 1 Stay on any RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with previously known and treated hypertension (treatment according to standard of care).

    Subject analysis set title
    Substudy B-Cohort 1 Switch to non RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with previously known and treated hypertension who switch to non-RAS blocking agents (treatment according to standard of care, e.g. nitrendipine, amlodipine or doxazosin)

    Subject analysis set title
    Substudy B-Cohort 2 Blopress
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for patients with blood pressure >130/85mmHg in two consecutive measurements with treatment of RAS blocking agent candesartan (Blopress)

    Subject analysis set title
    Substudy B-Cohort 2 non RAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subjects with treatment according to standard of care, e.g. with nitrendipine, amlodipine or doxazosin, or no treatment, if blood pressure <140/90mmHg.

    Subject analysis set title
    Substudy C- Asunercept high dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Asunercept high dose (400mg).

    Subject analysis set title
    Substudy C- Asunercept intermediate dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving for Asunercept intermedian dose (100mg).

    Subject analysis set title
    Substudy C- Asunercept low dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Asunercept low dose (25mg).

    Subject analysis set title
    Substudy C Asunercept standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving standard of care in substudy C Asunercept

    Subject analysis set title
    Substudy C Pentaglobin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving Pentaglobin

    Subject analysis set title
    Substudy C Pentaglobin standard of care
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Time to sustained improvement (i.e. >48h) of one category from baseline in the 7-point clinical performance scale, which were measured daily till day 29 for subject receiving standard of care in substudy C Pentaglobin

    Primary: Primary Endpoint Kaletra versus standard of care

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    End point title
    		 Primary Endpoint Kaletra versus standard of care
    End point description
    End point type
    Primary
    End point timeframe
    from day 1 to day 29
    End point values
    		 Main study: Kaletra Main study: Standard of care
    Number of subjects analysed
    101
    105
    Units: days
        median (inter-quartile range (Q1-Q3))
    11 (7 to 21)
    9 (6 to 12)
    Statistical analysis title
    		 Analysis primary endpoint Kaletra versus SOC
    Comparison groups
    Main study: Kaletra v Main study: Standard of care
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval

    Primary: Primary endpoint substudy A

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    End point title
    		 Primary endpoint substudy A
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to day 29
    End point values
    		 Substudy A: Xarelto Substudy A: standard of care
    Number of subjects analysed
    70
    73
    Units: days
        median (inter-quartile range (Q1-Q3))
    9 (6 to 12)
    8 (5 to 13)
    Statistical analysis title
    		 Analysis primary endpoint substudy A
    Comparison groups
    Substudy A: Xarelto v Substudy A: standard of care
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 > 0.05
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - Analysis is only exploratory due to premature termination of the study.

    Primary: Primary endpoint substudy C Asunercept

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    End point title
    		 Primary endpoint substudy C Asunercept
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to day 29
    End point values
    		 Substudy C- Asunercept high dose Substudy C- Asunercept intermediate dose Substudy C- Asunercept low dose Substudy C Asunercept standard of care
    Number of subjects analysed
    25
    23
    26
    25
    Units: days
        median (inter-quartile range (Q1-Q3))
    10 (7 to 21)
    12 (7 to 13)
    8 (6 to 11)
    7 (5 to 12)
    Statistical analysis title
    		 Analysis primary endpoint substudy C Asunercept
    Comparison groups
    Substudy C Asunercept standard of care v Substudy C- Asunercept high dose v Substudy C- Asunercept intermediate dose v Substudy C- Asunercept low dose
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 > 0.05
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Analysis is only exploratory due to premature termination of the study.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 to day 29
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: All adverse events have been uploaded in PDF

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2020
    • Deletion of IMP Chloroquin in main study due to urgent safety measure • Dose increase of IMP Lopinavir/Ritonavir in main study due to new information of required dose in Sars-CoV-2 infection • Additional IMPs for Sub-C: Tocilizumab, Asunercept • Sub-B: Adaptation of blood pressure level • Additional centers: Graz, Neunkirchen, Linz
    03 Nov 2020
    • Inactivation of IMP in main study: Hydroxychloroquine • Additional IMP in main study: Remdesivir (if not part of SOC) • Exchange of IMP in main study: Pooled plasma/IVIg against convalescent plasma • Additional IMP for Sub-C: Pentaglobin • Removal of IMPs for Sub-C: Tocilizumab, Clazakizumab
    23 Nov 2020
    • Remote SDV
    15 Dec 2020
    • Removal of IMP in main study: convalescent plasma
    12 Feb 2021
    • Day 90 Follow-up • Addition of interview study

    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
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