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    Clinical Trial Results:
    A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19

    Summary
    EudraCT number
    2020-001803-17
    Trial protocol
    GB   IT  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    v2(current)
    This version publication date
    27 Jan 2024
    First version publication date
    14 Dec 2023
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Updated to provide further clairification.

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-540-5823
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04431453
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd., +44 1223 897284, clinical.trials@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd., +44 1223 897284, clinical.trials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002826-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the safety, tolerability and pharmacokinetics (PK) of remdesivir (RDV ) in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years. The goals of this clinical study were to learn more about the study drug, RDV, and how safe it was in participants younger than 18 years with coronavirus disease 2019 (COVID-19) and who were hospitalized.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 44
    Worldwide total number of subjects
    59
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    1
    Newborns (0-27 days)
    5
    Infants and toddlers (28 days-23 months)
    13
    Children (2-11 years)
    24
    Adolescents (12-17 years)
    16
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Italy, Spain, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    60 participants were screened. 59 participants were enrolled in this study and 58 were treated.

    Pre-assignment period milestones
    Number of subjects started
    59
    Number of subjects completed
    58

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Enrolled but Never Treated: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg
    Arm description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg
    Arm description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg
    Arm description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg
    Arm description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Arm description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 6:Age≥0-<14 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Arm description
    Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV,Cohort 7:Age≥0-<56 Days, Gest. Age≤37 Weeks;Weight≥1.5kg
    Arm description
    Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Arm title
    RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Arm description
    Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    GS-5734
    Other name
    Veklury®
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Administered via intravenous infusion.

    Number of subjects in period 1 [1]
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV,Cohort 6:Age≥0-<14 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV,Cohort 7:Age≥0-<56 Days, Gest. Age≤37 Weeks;Weight≥1.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Started
    12
    12
    12
    12
    3
    1
    1
    5
    Completed
    11
    11
    11
    9
    3
    1
    1
    4
    Not completed
    1
    1
    1
    3
    0
    0
    0
    1
         Death
    1
    -
    -
    -
    -
    -
    -
    1
         Withdrew consent
    -
    1
    -
    2
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    1
    -
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant from the worldwide number enrolled in the trial in Cohort 5 did not receive the treatment, hence, the number of subjects in the baseline period are not the same as the worldwide number enrolled.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    58 58
    Age categorical
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Newborns (0-27 days)
    5 5
        Infants and toddlers (28 days-23 months)
    12 12
        Children (2-11 years)
    24 24
        Adolescents (12-17 years)
    16 16
        Preterm newborn - gestational age < 37 wk
    1 1
    Gender categorical
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Female
    33 33
        Male
    25 25
    Race
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        White
    37 37
        Black or African American
    15 15
        Other or More Than One Race
    6 6
    Ethnicity
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Not Hispanic or Latino
    34 34
        Hispanic or Latino
    23 23
        Unknown or Not Reported
    1 1
    Number of Participants With Clinical Status (7-Point Ordinal Scale) Score
    7-point scale: 1.Death;2.Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO);3.Hospitalized, on noninvasive ventilation or high-flow oxygen devices;4.Hospitalized,requiring low-flow supplemental oxygen;5.Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care(COVID-19 related/otherwise);6.Hospitalized, not requiring supplemental oxygen-no longer requiring ongoing medical care(other than per-protocol RDV administration);7.Not hospitalized. Cohorts 6,7 are not reported due to participants' confidentiality reason for arm-wise data.
    Units: Subjects
        Score 1
    0 0
        Score 2
    15 15
        Score 3
    20 20
        Score 4
    10 10
        Score 5
    12 12
        Score 6
    1 1
        Score 7
    0 0
    Oxygen Support Status
    Oxygen support status was derived from the 7-point ordinal scale, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Participants with Baseline oxygen status for scores: 2 'invasive mechanical ventilation'; 3 'High Flow Oxygen'; 4 'Low Flow Oxygen', and 5 or 6 'Room Air' are reported. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        High-flow oxygen
    20 20
        Low-flow oxygen
    10 10
        Room air
    13 13
        Invasive mechanical ventilation
    15 15
    Pediatric Early Warning Score (PEWS) Scale Score: Behavior
    Behavior:0=playing; appropriate; 1=sleeping; 2=irritable; 3=lethargic; confused; reduced response to pain. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Behavior: Score 0
    22 22
        Behavior: Score 1
    13 13
        Behavior: Score 2
    8 8
        Behavior: Score 3
    15 15
    PEWS: Cardiovascular Score
    Cardiovascular:0=normal; pink; capillary refill (cr) 1-2 seconds(secs);1=Tachycardia< 20 above normal for age;2=Tachycardia 20-29 above normal for age; gray; cr=4 secs;3=Tachycardia >=30 above/bradycardia >=10 below normal for age; Gray; cr>=5 secs. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Cardiovascular: Score 0
    35 35
        Cardiovascular: Score 1
    12 12
        Cardiovascular: Score 2
    5 5
        Cardiovascular: Score 3
    6 6
    PEWS: Respiratory Score
    Respiratory:0=Normal;1=Respiratory rate(rr)>10 above normal using accessory muscles; 30+%fraction of inspired oxygen(FiO2)/3+L/min; 2= rr>20 above normal and retractions;40%FiO2 or 6+L/min; 3 =rr>=5 below normal with retractions and grunting; 50%FiO2/8+L/min. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Respiratory: Score 0
    17 17
        Respiratory: Score 1
    10 10
        Respiratory: Score 2
    12 12
        Respiratory: Score 3
    19 19
    SARS-CoV-2 RNA Viral Load: Nasal/Oropharyngeal (OP) Swabs
    The assessment was done for the sample of nasal/OP swab. n= 5, 5, 4, 3, 1, 1; total = 19. Here, 'n' = participants with data available for the specific category. '9999' = Not available, data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    4.80 ( 1.998 ) -
    SARS-CoV-2 RNA Viral Load: Nasopharyngeal (NP)/ OP Swabs
    The assessment was done for the sample of NP/OP swab. n= 5, 4, 5, 7, 2, 4; total = 27. Here, 'n' = participants with data available for the specific category. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    5.78 ( 1.802 ) -
    SARS-CoV-2 RNA Viral Load: Endotracheal Tube Aspirates
    The assessment was done for the sample of endotracheal tube aspirates. n= 1, 4, 2, 3, 1, 0; total = 11. Here, 'n' = participants with data available for the specific category. '9999' = Not Available; data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    5.87 ( 2.180 ) -
    SARS-CoV-2 RNA Viral Load: Rectal/Fecal Swabs
    The assessment was done for the sample of rectal/fecal swabs. n= 8, 7, 8, 11, 3, 5; total = 42. Here, 'n' = participants with data available for the specific category. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    3.26 ( 1.297 ) -
    Subject analysis sets

    Subject analysis set title
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to<40kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kgto<20kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days

    Subject analysis set title
    RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.

    Subject analysis set title
    RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.

    Subject analysis sets values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to<40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kgto<20kg RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects
    12
    12
    12
    12
    3
    5
    Age categorical
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Newborns (0-27 days)
    0
    0
    0
    0
    3
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    1
    12
    0
    0
        Children (2-11 years)
    0
    8
    11
    0
    0
    5
        Adolescents (12-17 years)
    12
    4
    0
    0
    0
    0
        Preterm newborn - gestational age < 37 wk
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Female
    8
    7
    5
    7
    1
    3
        Male
    4
    5
    7
    5
    2
    2
    Race
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        White
    7
    9
    6
    8
    3
    3
        Black or African American
    5
    2
    4
    2
    0
    1
        Other or More Than One Race
    0
    1
    2
    2
    0
    1
    Ethnicity
    Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Not Hispanic or Latino
    8
    5
    5
    9
    3
    2
        Hispanic or Latino
    3
    7
    7
    3
    0
    3
        Unknown or Not Reported
    1
    0
    0
    0
    0
    0
    Number of Participants With Clinical Status (7-Point Ordinal Scale) Score
    7-point scale: 1.Death;2.Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO);3.Hospitalized, on noninvasive ventilation or high-flow oxygen devices;4.Hospitalized,requiring low-flow supplemental oxygen;5.Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care(COVID-19 related/otherwise);6.Hospitalized, not requiring supplemental oxygen-no longer requiring ongoing medical care(other than per-protocol RDV administration);7.Not hospitalized. Cohorts 6,7 are not reported due to participants' confidentiality reason for arm-wise data.
    Units: Subjects
        Score 1
    0
    0
    0
    0
    0
    0
        Score 2
    1
    3
    3
    5
    2
    0
        Score 3
    6
    4
    3
    3
    1
    2
        Score 4
    2
    3
    0
    3
    0
    2
        Score 5
    3
    2
    6
    0
    0
    1
        Score 6
    0
    0
    0
    1
    0
    0
        Score 7
    0
    0
    0
    0
    0
    0
    Oxygen Support Status
    Oxygen support status was derived from the 7-point ordinal scale, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Participants with Baseline oxygen status for scores: 2 'invasive mechanical ventilation'; 3 'High Flow Oxygen'; 4 'Low Flow Oxygen', and 5 or 6 'Room Air' are reported. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        High-flow oxygen
    6
    4
    3
    3
    1
    2
        Low-flow oxygen
    2
    3
    0
    3
    0
    2
        Room air
    3
    2
    6
    1
    0
    1
        Invasive mechanical ventilation
    1
    3
    3
    5
    2
    0
    Pediatric Early Warning Score (PEWS) Scale Score: Behavior
    Behavior:0=playing; appropriate; 1=sleeping; 2=irritable; 3=lethargic; confused; reduced response to pain. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Behavior: Score 0
    7
    6
    5
    2
    0
    2
        Behavior: Score 1
    3
    3
    2
    3
    1
    1
        Behavior: Score 2
    1
    0
    2
    3
    0
    1
        Behavior: Score 3
    1
    3
    3
    4
    2
    1
    PEWS: Cardiovascular Score
    Cardiovascular:0=normal; pink; capillary refill (cr) 1-2 seconds(secs);1=Tachycardia< 20 above normal for age;2=Tachycardia 20-29 above normal for age; gray; cr=4 secs;3=Tachycardia >=30 above/bradycardia >=10 below normal for age; Gray; cr>=5 secs. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Cardiovascular: Score 0
    9
    7
    7
    8
    1
    2
        Cardiovascular: Score 1
    1
    2
    3
    1
    2
    3
        Cardiovascular: Score 2
    2
    1
    0
    1
    0
    0
        Cardiovascular: Score 3
    0
    2
    2
    2
    0
    0
    PEWS: Respiratory Score
    Respiratory:0=Normal;1=Respiratory rate(rr)>10 above normal using accessory muscles; 30+%fraction of inspired oxygen(FiO2)/3+L/min; 2= rr>20 above normal and retractions;40%FiO2 or 6+L/min; 3 =rr>=5 below normal with retractions and grunting; 50%FiO2/8+L/min. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: Subjects
        Respiratory: Score 0
    4
    1
    6
    4
    0
    2
        Respiratory: Score 1
    2
    5
    2
    0
    1
    0
        Respiratory: Score 2
    3
    2
    2
    3
    0
    1
        Respiratory: Score 3
    3
    4
    2
    5
    2
    2
    SARS-CoV-2 RNA Viral Load: Nasal/Oropharyngeal (OP) Swabs
    The assessment was done for the sample of nasal/OP swab. n= 5, 5, 4, 3, 1, 1; total = 19. Here, 'n' = participants with data available for the specific category. '9999' = Not available, data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    5.35 ( 1.796 )
    4.87 ( 2.807 )
    3.18 ( 0.967 )
    5.41 ( 2.165 )
    5.02 ( 9999 )
    6.20 ( 9999 )
    SARS-CoV-2 RNA Viral Load: Nasopharyngeal (NP)/ OP Swabs
    The assessment was done for the sample of NP/OP swab. n= 5, 4, 5, 7, 2, 4; total = 27. Here, 'n' = participants with data available for the specific category. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    5.93 ( 2.172 )
    5.37 ( 1.879 )
    5.67 ( 2.273 )
    5.55 ( 1.854 )
    5.99 ( 0.183 )
    6.12 ( 1.628 )
    SARS-CoV-2 RNA Viral Load: Endotracheal Tube Aspirates
    The assessment was done for the sample of endotracheal tube aspirates. n= 1, 4, 2, 3, 1, 0; total = 11. Here, 'n' = participants with data available for the specific category. '9999' = Not Available; data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    5.36 ( 9999 )
    5.58 ( 3.554 )
    6.09 ( 0.840 )
    6.68 ( 1.540 )
    4.63 ( 9999 )
    99999 ( 99999 )
    SARS-CoV-2 RNA Viral Load: Rectal/Fecal Swabs
    The assessment was done for the sample of rectal/fecal swabs. n= 8, 7, 8, 11, 3, 5; total = 42. Here, 'n' = participants with data available for the specific category. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups for arm-wise data.
    Units: log10 copies per mL
        arithmetic mean (standard deviation)
    3.30 ( 1.593 )
    2.63 ( 0.757 )
    2.72 ( 1.034 )
    3.84 ( 1.341 )
    4.27 ( 1.107 )
    2.75 ( 1.274 )

    End points

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    End points reporting groups
    Reporting group title
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg
    Reporting group description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg
    Reporting group description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg
    Reporting group description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg
    Reporting group description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Reporting group description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 6:Age≥0-<14 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Reporting group description
    Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV,Cohort 7:Age≥0-<56 Days, Gest. Age≤37 Weeks;Weight≥1.5kg
    Reporting group description
    Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days.

    Reporting group title
    RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Reporting group description
    Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to<40kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kgto<20kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days.

    Subject analysis set title
    RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days

    Subject analysis set title
    RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.

    Subject analysis set title
    RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.

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

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    End point title
    Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [1] [2]
    End point description
    TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. Analysis Population Description: Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    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: The statistical analyses were not available for this endpoint. Only descriptive data provided were analysed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12
    3
    5
    Units: percentage of participants
        number (not applicable)
    91.7
    58.3
    75.0
    58.3
    66.7
    80.0
    No statistical analyses for this end point

    Primary: Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities

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    End point title
    Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities [3] [4]
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days. The laboratory abnormalities were graded using division of allergy and infectious diseases (DAIDS) scale. DAIDS scale is used to grade the severity of adult and pediatric unwanted medical events. Grade 1: mild event, Grade 2: moderate event, Grade: serious event, Grade 4: potentially life-threatening event. Analysis Population Description:The RDV and Metabolites PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentrations of RDV and metabolites were available.
    End point type
    Primary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analyses were not available for this endpoint. Only descriptive data provided were analysed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    11
    3
    5
    Units: percentage of participants
    number (not applicable)
        Any grade
    100
    83.3
    91.7
    90.9
    100
    80.0
        Grade 3 or 4
    75.0
    16.7
    41.7
    36.4
    100
    60.0
    No statistical analyses for this end point

    Primary: Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and its Metabolites GS-704277 and GS-441524 at Steady State

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    End point title
    Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and its Metabolites GS-704277 and GS-441524 at Steady State [5] [6]
    End point description
    Cmax is defined as maximum plasma concentration of drug. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Days 2 and 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. Analysis Population Description: The RDV PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentrations of RDV were available. The Metabolites PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentrations of metabolites were available.
    End point type
    Primary
    End point timeframe
    Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
    Notes
    [5] - 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: The statistical analyses were not available for this endpoint. Only descriptive data provided were analysed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    11
    10
    3
    5
    Units: ng/mL
    arithmetic mean (standard deviation)
        Remdesivir
    4108.7 ( 1365.15 )
    6003.5 ( 1879.86 )
    5980.1 ( 2284.08 )
    5192.9 ( 2066.65 )
    4829.0 ( 956.16 )
    4235.7 ( 1790.53 )
        GS-704277
    360.6 ( 208.11 )
    469.0 ( 239.72 )
    484.8 ( 244.07 )
    407.8 ( 132.45 )
    466.0 ( 110.87 )
    297.9 ( 160.18 )
        GS-441524_
    276.4 ( 327.14 )
    210.5 ( 121.02 )
    186.5 ( 103.09 )
    209.8 ( 49.73 )
    371.8 ( 151.10 )
    230.4 ( 255.03 )
    No statistical analyses for this end point

    Primary: PK Parameter: AUCtau of Remdesivir and its Metabolites GS-704277 and GS-441524 at Steady State

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    End point title
    PK Parameter: AUCtau of Remdesivir and its Metabolites GS-704277 and GS-441524 at Steady State [7] [8]
    End point description
    AUCtau is defined as area under the concentration versus time curve over the dosing interval. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Days 2 and 3, with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. Analysis Population Description: The RDV PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentration data of RDV were available. The Metabolites PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentration data of metabolites were available.
    End point type
    Primary
    End point timeframe
    Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
    Notes
    [7] - 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: The statistical analyses were not available for this endpoint. Only descriptive data provided were analysed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    11
    10
    3
    5
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Remdesivir
    2630.1 ( 923.85 )
    3937.9 ( 1981.40 )
    6752.1 ( 10911.98 )
    3625.7 ( 3361.19 )
    2650.3 ( 587.77 )
    2519.6 ( 1235.49 )
        GS-704277
    1222.9 ( 1348.12 )
    860.3 ( 512.58 )
    876.0 ( 720.39 )
    776.0 ( 485.18 )
    1049.0 ( 253.73 )
    671.4 ( 553.30 )
        GS-441524_
    5486.2 ( 7599.27 )
    3016.1 ( 2425.78 )
    2751.8 ( 1868.93 )
    2969.1 ( 940.73 )
    6899.3 ( 3910.28 )
    4336.8 ( 5692.30 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale

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    End point title
    Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale [9]
    End point description
    The 7-point ordinal scales were: 1 = death; 2 = hospitalized, on invasive mechanical ventilation or ECMO; 3 = hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = hospitalized, requiring low flow supplemental oxygen; 5 = hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6 = hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration); 7 = not hospitalized. Participants with ≥ 1-point; ≥ 2-point improvement on scale and recovery are reported. Recovery is defined as an improvement from a baseline score of 2 through 5 to a score of 6 or 7 or an improvement from a baseline score of 6 to a score of 7. Participants from FAS population with data available for analysis. Here 'n' are participants analysed.
    End point type
    Secondary
    End point timeframe
    Day 10
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12 [10]
    3
    5
    Units: percentage of participants
    number (confidence interval 95%)
        ≥ 1-point Improvement from Baseline
    50.0 (21.1 to 78.9)
    91.7 (61.5 to 99.8)
    100 (73.5 to 100)
    58.3 (27.7 to 84.8)
    33.3 (0.8 to 90.6)
    80.0 (28.4 to 99.5)
        ≥ 2-point Improvement from Baseline
    41.7 (15.2 to 72.3)
    91.7 (61.5 to 99.8)
    100 (73.5 to 100)
    54.5 (23.4 to 83.3)
    33.3 (0.8 to 90.6)
    80.0 (28.4 to 99.5)
        Recovery
    25.0 (5.5 to 57.2)
    75.0 (42.8 to 94.5)
    91.7 (61.5 to 99.8)
    41.7 (15.2 to 72.3)
    33.3 (0.8 to 90.6)
    80.0 (28.4 to 99.5)
    Notes
    [10] - n=12,11,12
    No statistical analyses for this end point

    Secondary: Time (Days) to Discharge From Hospital

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    End point title
    Time (Days) to Discharge From Hospital [11]
    End point description
    Time to discharge is defined as duration from first dose date to getting discharged from the hospital. Analysis Population Description: The participants in the Full Analysis Set who were discharged alive on or prior to Day 30 were analysed. Description for '999' = Median and upper bound of range (Q3) could not be calculated because less than 50% and 75% of participants, respectively, experienced the event. Hence the days were reported as '999'.
    End point type
    Secondary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12
    3
    5
    Units: days
        median (inter-quartile range (Q1-Q3))
    12 (8 to 24)
    7 (5 to 9)
    5 (4 to 9)
    7 (4 to 19)
    999 (9 to 999)
    10 (4 to 18)
    No statistical analyses for this end point

    Secondary: Number of Participants With Change From Baseline in Oxygenation Use

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    End point title
    Number of Participants With Change From Baseline in Oxygenation Use [12]
    End point description
    Oxygen support status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Participants with shift from Baseline in scores are reported. Analysis Population Description: Participants in Full Analysis Set with Oxygenation use status as 'High Flow Oxygen', 'Low Flow Oxygen' and 'Room Air' at Baseline were analysed.
    End point type
    Secondary
    End point timeframe
    Day 10
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    11 [13]
    9 [14]
    9 [15]
    7 [16]
    1 [17]
    5 [18]
    Units: percentage of participants
    number (not applicable)
        High flow oxygen (HFO) (Baseline); Death (Day 10)
    0
    0
    0
    0
    0
    0
        HFO (Baseline); IMV (Day 10)
    2
    0
    0
    0
    0
    1
        HFO (Baseline); HFO (Day 10)
    1
    0
    0
    0
    0
    0
        HFO (Baseline); Low Flow oxygen (LFO) (Day 10)
    0
    0
    0
    0
    0
    0
        HFO (Baseline); Room Air (Day 10)
    2
    0
    0
    0
    0
    0
        HFO (Baseline); Discharge (Day 10)
    1
    4
    3
    2
    1
    1
        HFO (Baseline); Missing (Day 10)
    0
    0
    0
    1
    0
    0
        LFO (Baseline); Death (Day 10)
    0
    0
    0
    0
    0
    0
        LFO (Baseline); IMV (Day 10)
    0
    0
    0
    0
    0
    0
        LFO (Baseline); HFO (Day 10)
    0
    0
    0
    0
    0
    0
        LFO (Baseline); LFO (Day 10)
    0
    0
    0
    1
    0
    0
        LFO (Baseline); Room Air (Day 10)
    1
    0
    0
    0
    0
    1
        LFO (Baseline); Discharge (Day 10)
    1
    3
    0
    2
    0
    1
        LFO (Baseline); Missing (Day 10)
    0
    0
    0
    0
    0
    0
        Room Air (Baseline); Death (Day 10)
    0
    0
    0
    0
    0
    0
        Room Air (Baseline); IMV (Day 10)
    0
    0
    0
    0
    0
    0
        Room Air (Baseline); HFO (Day 10)
    0
    0
    0
    0
    0
    0
        Room Air (Baseline); LFO (Day 10)
    0
    0
    0
    0
    0
    0
        Room Air (Baseline); Room Air (Day 10)
    2
    0
    0
    0
    0
    0
        Room Air (Baseline); Discharge (Day 10)
    1
    2
    6
    1
    0
    1
        Room Air (Baseline); Missing (Day 10)
    0
    0
    0
    0
    0
    0
    Notes
    [13] - High flow oxygen (n=6),Low flow oxygen (n=2),Room air (n=3)
    [14] - High flow oxygen(n=4), Low flow oxygen(n=3), Room air(n=2)
    [15] - High flow oxygen(n=3), Low flow oxygen(n=0), Room air(n=6)
    [16] - High flow oxygen(n=3), Low flow oxygen(n=3), Room air(n=1)
    [17] - High flow oxygen(n=1), Low flow oxygen(n=0), Room air(n=0)
    [18] - High flow oxygen(n=2), Low flow oxygen(n=2), Room air(n=1)
    No statistical analyses for this end point

    Secondary: Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)

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    End point title
    Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) [19]
    End point description
    Mechanical ventilation status was derived from the 7-point ordinal scale, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Participants with shift from Baseline in scores are reported. Only categories with data are reported. Analysis Population Description: Participants in Full Analysis Set with Oxygenation use status as 'Mechanical Ventilation or ECMO' at Baseline were analysed. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in this group.
    End point type
    Secondary
    End point timeframe
    Day 10
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    1
    3
    3
    5
    2
    0 [20]
    Units: participants
        Death
    0
    0
    0
    0
    0
        Invasive Mechanical ventilation
    1
    1
    0
    2
    2
        High Flow Oxygen
    0
    0
    0
    0
    0
        Low Flow Oxygen
    0
    1
    0
    0
    0
        Room Air
    0
    0
    1
    2
    0
        Discharge
    0
    0
    2
    0
    0
        Missing
    0
    1
    0
    1
    0
    Notes
    [20] - No participant had the baseline score of 2 in this cohort.
    No statistical analyses for this end point

    Secondary: Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result

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    End point title
    Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result [21]
    End point description
    Confirmed negative PCR is defined by as 2 consecutive negative PCR results or negative result at the last available sample for participants who completed or discontinued from the study. The assessments were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs. Analysis Population Description: The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Description for '9999' = Median days to event could not be calculated because less than 50% of participants experienced the event. Hence the days were reported as '9999'.
    End point type
    Secondary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12
    3
    5
    Units: days
    median (inter-quartile range (Q1-Q3))
        Nasal/OP Samples
    9999 (5 to 9999)
    5 (3 to 9999)
    7 (5 to 9999)
    9999 (4 to 9999)
    10 (10 to 10)
    9999 (9999 to 9999)
        NP/OP Samples
    9999 (9999 to 9999)
    9999 (7 to 9999)
    9999 (5 to 9999)
    9999 (10 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
        ET Aspirates
    9999 (9999 to 9999)
    9999 (3 to 9999)
    9999 (9999 to 9999)
    9999 (3 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
        Rectal/Faecal Samples
    5 (3 to 10)
    3 (3 to 5)
    5 (3 to 9999)
    7 (5 to 9999)
    3 (3 to 5)
    4 (3 to 7)
    No statistical analyses for this end point

    Secondary: Change from Baseline in SARS-CoV-2 Viral Load up to Day 10 or up to the First Confirmed Negative PCR Result

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    End point title
    Change from Baseline in SARS-CoV-2 Viral Load up to Day 10 or up to the First Confirmed Negative PCR Result [22]
    End point description
    Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first negative PCR result with confirmation (whichever comes first) were reported. The assessments were done for the samples: nasal/OP samples; NP/OP samples; ET aspirates; rectal or fecal swabs. Here, 'n'=participants with data available for the specific category. Analysis Population Description: The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Number analyzed are participants with data available for analysis for the specific category. '9999'=SD could not be estimated for 1 participant. '99999'=No participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 10, and Day of Discharge (Day 10 or before)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12 [23]
    12 [24]
    12 [25]
    12 [26]
    3 [27]
    5 [28]
    Units: log10 copies per mL
    arithmetic mean (standard deviation)
        Nasal/OP Samples, Change at Day 10
    -3.01 ( 9999 )
    99999 ( 99999 )
    0 ( 0 )
    99999 ( 99999 )
    -2.36 ( 9999 )
    -1.76 ( 9999 )
        Nasal/OP Samples, Change at Discharge
    99999 ( 99999 )
    -4.65 ( 9999 )
    99999 ( 99999 )
    -1.56 ( 1.228 )
    99999 ( 99999 )
    99999 ( 99999 )
        NP/OP Samples, Change at Day 10
    99999 ( 99999 )
    -2.17 ( 2.197 )
    99999 ( 99999 )
    -2.60 ( 1.283 )
    -3.28 ( 0.183 )
    0.46 ( 9999 )
        NP/OP Samples, Change at Discharge
    -2.86 ( 9999 )
    -3.72 ( 9999 )
    -0.87 ( 1.391 )
    1.42 ( 9999 )
    99999 ( 99999 )
    -0.05 ( 1.184 )
        ET aspirates, Change at Day 10
    99999 ( 99999 )
    -5.94 ( 9999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -1.92 ( 9999 )
    99999 ( 99999 )
        ET aspirates, Change at Discharge
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Rectal or Fecal Swabs, Change at Day 10
    0.38 ( 9999 )
    -0.39 ( 9999 )
    99999 ( 99999 )
    -1.87 ( 9999 )
    99999 ( 99999 )
    1.38 ( 9999 )
        Rectal or Fecal Swabs, Change at Discharge
    99999 ( 99999 )
    1.12 ( 9999 )
    -0.09 ( 1.999 )
    -1.47 ( 0.479 )
    99999 ( 99999 )
    0 ( 0 )
    Notes
    [23] - n=1,0,0,1,0,0,1,0
    [24] - n=0,1,2,1,1,0,1,1
    [25] - n=1,0,0,3,0,0,0,2
    [26] - n=0,2,3,1,0,0,1,3
    [27] - n=1,0,2,0,1,0,0,0
    [28] - n=1,0,1,3,0,0,1,2
    No statistical analyses for this end point

    Secondary: Bilirubin Concentrations in < 14-day-old Participants

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    End point title
    Bilirubin Concentrations in < 14-day-old Participants [29]
    End point description
    Analysis Population Description: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. No data displayed because Outcome Measure has zero total participants analysed.
    End point type
    Secondary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV,Cohort 6:Age≥0-<14 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV,Cohort 7:Age≥0-<56 Days, Gest. Age≤37 Weeks;Weight≥1.5kg
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: mg/dL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [30] - Data were not reported due to participants' confidentiality reasons.
    [31] - Data were not reported due to participants' confidentiality reasons.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale

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    End point title
    Percentage of Participants Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale [32]
    End point description
    The PEWS was measured by 3 components, where 1= behavior, 2= perfusion assessed by capillary refill and heart rate, and 3= respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranged between 0 to 9 point, with higher score representing the highest severity level. A negative change from baseline value indicated an improvement. Data are reported for participants with a PEWS behavior score ≥ 2 at baseline, and a ≥ 2-point improvement (indicated by a decrease) in PEWS behavior score by Day 10, participants with a PEWS behavior score ≥ 1 at baseline, with ≥ 1-point improvement in PEWS behavior score by Day 10 and participants who recovered in PEWS behavior, defined as a Baseline score of 1 through 3 improved to a score of 0. The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Here 'n' are participants with data available for analyses for the specific category.
    End point type
    Secondary
    End point timeframe
    Day 10
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12
    3
    5
    Units: percentage of participants
    number (confidence interval 95%)
        ≥ 2-point Improvement from Baseline- Respiratory
    33.3 (4.3 to 77.7)
    83.3 (35.9 to 99.6)
    75 (19.4 to 99.4)
    42.9 (9.9 to 81.6)
    0 (0 to 84.2)
    66.7 (9.4 to 99.2)
        ≥ 1-point Improvement from Baseline- Respiratory
    50.0 (15.7 to 84.3)
    81.8 (48.2 to 97.7)
    83.8 (35.9 to 99.6)
    42.9 (9.9 to 81.6)
    33.3 (0.3 to 90.6)
    66.7 (9.4 to 99.2)
        Recovery- Respiratory
    37.5 (8.5 to 75.5)
    81.8 (48.2 to 97.7)
    83.3 (35.9 to 99.6)
    42.9 (9.9 to 81.6)
    33.3 (0.8 to 90.6)
    66.7 (9.4 to 99.2)
        ≥ 2-point Improvement from Baseline- Behavior
    0 (0 to 84.2)
    33.3 (0.8 to 90.6)
    100 (47.8 to 100)
    66.7 (22.3 to 95.7)
    0 (0 to 84.2)
    50 (1.3 to 98.7)
        ≥ 1-point Improvement from Baseline- Behavior
    40 (5.3 to 85.3)
    66.7 (22.3 to 95.7)
    100 (59 to 100)
    66.7 (29.9 to 92.5)
    66.7 (9.4 to 99.2)
    33.3 (0.8 to 90.6)
        Recovery- Behavior
    40 (5.3 to 85.3)
    66.7 (22.3 to 95.7)
    100 (59 to 100)
    55.6 (21.2 to 86.3)
    33.3 (0.8 to 90.6)
    33.3 (0.8 to 90.6)
        ≥ 2-point Improvement from Baseline-Cardiovascular
    0 (0 to 84.2)
    66.7 (9.4 to 99.2)
    100 (15.8 to 100)
    100 (15.8 to 100)
    0 (0 to 0)
    0 (0 to 0)
        ≥ 1-point Improvement from Baseline-Cardiovascular
    33.3 (0.8 to 90.6)
    80 (28.4 to 99.5)
    100 (47.8 to 100)
    66.7 (9.4 to 99.2)
    50 (1.3 to 98.7)
    66.7 (9.4 to 99.2)
        Recovery- Cardiovascular
    0 (0 to 70.8)
    80 (28.4 to 99.5)
    100 (47.8 to 100)
    33.3 (0.8 to 90.6)
    50 (1.3 to 98.7)
    66.7 (9.4 to 99.2)
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)

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    End point title
    Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) [33]
    End point description
    Plasma concentrations were drawn as follows: (1) for cohorts 1-4 and 8 on Day 2 and Day 3, with Day 5 as optional; (2) for cohorts 5-7 on Day 2 or Day 3. Analysis Population Description: The SBECD PK Analysis Set included all participants who were enrolled and received at least 1 dose of RDV and for whom PK concentrations of SBECD were available. Here, 'n' = participants with data available for the specific category. Description for '9999' = Data were not available as the concentrations were below the level of quantification (BLQ). '99999' = No participants.
    End point type
    Secondary
    End point timeframe
    Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12 [34]
    12 [35]
    11 [36]
    10 [37]
    3 [38]
    5 [39]
    Units: ug/mL
    arithmetic mean (standard deviation)
        Day 2, End of Infusion
    217.7 ( 262.32 )
    173.0 ( 119.06 )
    187.8 ( 75.89 )
    138.3 ( 104.06 )
    9999 ( 9999 )
    156.6 ( 57.21 )
        Day 2, 4 Hours
    110.1 ( 270.72 )
    24.3 ( 23.90 )
    14.2 ( 15.03 )
    36.2 ( 32.75 )
    9999 ( 9999 )
    16.2 ( 8.31 )
        Day 3, Pre-Infusion
    78.5 ( 209.65 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Day 3, 2 Hours
    90.1 ( 221.54 )
    47.5 ( 52.62 )
    47.4 ( 38.99 )
    58.2 ( 25.89 )
    61.0 ( 79.20 )
    48.0 ( 50.41 )
        Day 5, Middle of Infusion
    229.0 ( 221.14 )
    105.5 ( 72.05 )
    156.3 ( 23.12 )
    118.2 ( 121.22 )
    99999 ( 99999 )
    184.2 ( 131.82 )
        Day 5, 6 Hours
    141.2 ( 261.96 )
    6.6 ( 3.15 )
    9999 ( 9999 )
    12.4 ( 9.89 )
    99999 ( 99999 )
    9999 ( 9999 )
    Notes
    [34] - (n=10,10,10, 11,6,3)
    [35] - (n=12,11,10,12,5,4)
    [36] - (n=10,10,10,9,3,2)
    [37] - (n=9,9,8,7,5,4)
    [38] - (n=1,1,2,2,0,0)
    [39] - (n=5,4,5,5,3,2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of Coronavirus Disease 2019 (COVID-19)

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    End point title
    Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of Coronavirus Disease 2019 (COVID-19) [40]
    End point description
    Participants who received at least one concomitant non study COVID-19 medication from the first day of RDV treatment through the 30-day Follow-up visit or early withdrawal are reported. Analysis Population Description: The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point type
    Secondary
    End point timeframe
    From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
    End point values
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥40 kg RDV,Cohort 2:Age ≥28 Days to <18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to <20kg RDV,Cohort 4:Age ≥28 Days to <18 Years;Weight ≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Gest. Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Number of subjects analysed
    12
    12
    12
    12
    3
    5
    Units: percentage of participants
        number (not applicable)
    100
    100
    83.3
    83.3
    66.7
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality: First dose date up to approximately 8 weeks; Adverse events: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
    Adverse event reporting additional description
    All-cause mortality: All Enrolled Analysis Set will include all subjects who are enrolled into the study. Adverse events: Safety Analysis Set included all enrolled participants who received at least one dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥ 40 kg
    Reporting group description
    Patients who received RDV Cohort 1: Age 12 to <18 Years and Weight ≥40 kg

    Reporting group title
    RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to <40kg
    Reporting group description
    Patients who received RDV Cohort 2: Age 28 Days to <18 Years and Weight 20 to <40 kg

    Reporting group title
    RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to<20kg
    Reporting group description
    Patients who received RDV Cohort 3: Age 28 Days to <18 Years and Weight 12 to <20 kg

    Reporting group title
    RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg
    Reporting group description
    Patients who received RDV Cohort 4: Age 28 Days to <18 Years and Weight 3 to <12 kg

    Reporting group title
    RDV,Cohort 5:Age≥14-<28 Days, Birth Age>37 Weeks;Weight≥2.5kg
    Reporting group description
    Patients who received RDV Cohort 5: Age 14 to <28 Days, Gest. Age > 37 Wks. and Weight ≥ 2.5 kg

    Reporting group title
    RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Reporting group description
    Patients who received RDV Cohort 8: Age <12 Years and Weight ≥40 kg

    Serious adverse events
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥ 40 kg RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to<20kg RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Birth Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Haemodynamic instability
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Thrombosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction ~ syndrome
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Negative pressure pulmonary ~ oedema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    RDV, Cohort 1: Age 12 to <18 Years and Weight ≥ 40 kg RDV,Cohort 2:Age ≥ 28 Days to< 18 Years;Weight ≥20 kg to <40kg RDV,Cohort 3:Age≥28 Days to <18Years;Weight ≥12 kg to<20kg RDV,Cohort 4:Age≥28 Days to< 18 Years;Weight≥3kg to <12kg RDV,Cohort 5:Age≥14-<28 Days, Birth Age>37 Weeks;Weight≥2.5kg RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    7 / 12 (58.33%)
    9 / 12 (75.00%)
    7 / 12 (58.33%)
    2 / 3 (66.67%)
    4 / 5 (80.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    0
    0
    2
    2
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Physical deconditioning
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Inflammation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Pneumomediastinum
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Bronchospasm
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lung opacity
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Respiratory acidosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Respiratory distress
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory failure
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Agitation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    Delirium
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Product issues
    Device leakage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Device occlusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    0
    0
    1
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bacterial test positive
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood glucose decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood sodium increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Breath sounds abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vitamin C decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oxygen saturation abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Calcium ionised decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Ventricular septal defect
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Coronary artery dilatation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Cardiac arrest
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cardiomegaly
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Myocarditis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    1
    2
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    Constipation
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    3 / 5 (60.00%)
         occurrences all number
    3
    1
    2
    1
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Anal pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pancreatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ileus
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 12 (33.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    4
    0
    0
    1
    0
    1
    Polyuria
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Chest wall haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Myositis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Fungal cystitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    0
    Vitamin K deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Abnormal loss of weight
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2020
    • Added Exclusion criteria #8 for positive pregnancy at Screening. • Specified that the respiratory rate was not to be collected for subjects that were not on a ventilator. • Clarified that blood/urine screening samples were not needed to be repeated if done in the preceding 48 hours. • Updated the SARS-CoV-2 PCR testing and viral sequencing to include nasal and oropharyngeal samples (combined). • Added “and HCl and NaOH for pH adjustment.” To RDV formulation for clarity. • Updated the eGFR units to (mL/min/1.73 m2) to add /1.73 m2 throughout document. • Updated the collection of Apgar score at 10 min to last recorded score throughout document. • Clarified the Prohibited Concomitant Medications to include Investigational agents for COVID-19 with direct antiviral effect and added rifabutin, carbamazepine, phenytoin. • Added Contraceptive requirement for participating subjects at Screening and during the study as outlined in the new Appendix. • Added the collection of 1 to 2 mL optional blood collection to Day 1 OR Day 4 for future analysis and updated Appendix. • Added instructions to use smallest possible blood vials for sample collection for subjects <15kg.
    22 Sep 2020
    • Increased the number of centers planned to 35. • Clarified the number of participants planned for the study as at least 52. • Added exploratory Cohort 8 for participants < 12 years ≥ 40kg and updated language throughout the document to include Cohort 8. • Clarified the PK collection windows. • Updated the Exploratory Objectives of the Study to include analysis for participants with BMI for age ≥ 95th percentile. • Clarified language for exclusion criteria #8 per FDA comment. • Added exclusion criteria #9 for participants on renal replacement therapies. • Clarified the screening window for laboratory assessments per FDA comment. • Clarified the k value in the Schwartz formula. • Updated renal replacement therapies as a criterion for discontinuation. • Updated Study Rationale to add latest findings from healthy volunteer studies as well as results from Simple and NAID studies. • Updated the Rationale for Dose Selection to remove age requirement. • Clarified the Risk/Benefit Assessment for participants ≥ 2 years and included pandemic risk management language. • Added Toxicity Management. • Updated the Samples for Optional Future Research language. • Included a new Appendix 6 for pandemic risk management. • Replaced “viral sequencing” with “viral resistance testing” throughout the document. • Updated SARS-CoV-2 PCR to SARS-CoV-2 RT-qPCR throughout the document. • Updated PVE to GLPS throughout document. • Made additional updates for clarity throughout the document. • Made additional formatting and administrative updates and minor grammatical corrections throughout the document; these are not explicitly outlined in the changes below. New text is indicated by Bold and Strikethrough.
    16 Feb 2021
    • Updated the List of In-Text Tables for consistency. • Updated Study Rationale to add safety information as presented in the current USPI labeling. • Added Grade 3/ 4 laboratory abnormalities that occurred in Studies NIAID ACTT-1, GS-US-540-5773 and GS-US-540-5774. • Revised the Risk/Benefit Assessment for treatment-emergent elevations in ALT and AST which were observed in healthy volunteers and study participants with COVID-19. • Updated the IMP Return or Disposal to add remote monitoring visits. • Updated the routine coagulation test for Cohorts 5, 6 and 7. • Revised the blood volume tables for Cohorts 5, 6 and 7. • Made additional updates for clarity throughout the document. • Made additional formatting and administrative updates and minor grammatical corrections throughout the document; these are not explicitly outlined in the changes below. New text is indicated by Bold and Strikethrough.
    06 Jan 2022
    • Incorporate the dose for Cohorts 6 (0 days to < 14 days of age, gestational age > 37 weeks and birth weight ≥ 2.5 kg) and 7 (0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg). • The introduction was updated to incorporate a rationale for the dose selection for Cohorts 6 and 7. • The introduction was updated with current COVID-19 epidemiology data, as well as safety and efficacy data from a clinical study evaluating RDV in non-hospitalized participants with COVID-19 as well as interim results from the current study in pediatric participants with COVID-19. • Additional changes to the protocol include the following: • The following style update was made throughout the document: the term “subjects” was replaced with “participants”. • Administrative, editorial, and formatting updates, changes, corrections, and clarifications were made throughout, where appropriate, including section numbering and references. • Changes in the body of the protocol were also updated in the synopsis and study procedures table(s), as appropriate.

    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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