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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GS-US-540-5823

ISRCTN number

US NCT number

NCT04431453

WHO universal trial number (UTN)

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

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?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

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?

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

Independent data monitoring committee (IDMC) involvement?

Yes

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

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled at study sites in Italy, Spain, the United Kingdom, and the United States.

Screening details

60 participants were screened. 59 participants were enrolled in this study and 58 were treated.

Number of subjects started

Number of subjects completed

Reason: Number of subjects

Enrolled but Never Treated: 1

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

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.

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.

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.

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.

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.

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.

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.

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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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 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

Top of page

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

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

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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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 name

MedDRA

Dictionary version

26.0

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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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

Secondary: Time (Days) to Discharge From Hospital

Secondary: Time (Days) to Discharge From Hospital

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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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