Study of Remdesivir in Participants Below 18 Years Old With COVID-19

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04431453

Acronym

CARAVAN

Enrollment

Registered

2020-06-16

Start date

2020-07-21

Completion date

2023-02-10

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).

Detailed description

Pediatric participants will be enrolled as follows: Pediatric participants ≥ 28 days to \< 18 years old: * Cohort 1: ≥ 12 years to \< 18 years and weight ≥ 40 kg * Cohort 2: ≥ 28 days to \< 18 years and weight ≥ 20 kg to \< 40 kg * Cohort 3: ≥ 28 days to \< 18 years and weight ≥ 12 kg to \< 20 kg * Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * Cohort 8: \< 12 years and weight ≥ 40 kg Term neonatal participants 0 days to \< 28 days old: * Cohort 5: ≥ 14 days to \< 28 days of age, gestational age \> 37 weeks and weight at screening ≥ 2.5 kg * Cohort 6: 0 days to \< 14 days of age, gestational age \> 37 weeks and birth weight ≥ 2.5 kg Preterm neonates and infants 0 days to \< 56 days old: * Cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg

Interventions

DRUGRemdesivir

Administered as an intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Aged \< 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)). * a) Cohort 1: ≥ 12 years to \< 18 years of age and weight at screening ≥ 40 kg * b) Cohorts 2-4: ≥ 28 days to \< 18 years of age and weight at screening ≥ 3 kg and \< 40 kg * c) Cohort 5: ≥ 14 days to \< 28 days of age, gestational age \> 37 weeks and weight at screening ≥ 2.5 kg * d) Cohort 6: 0 days to \< 14 days of age, gestational age \> 37 weeks and birth weight of ≥ 2.5 kg * e) Cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg * f) Cohort 8: \< 12 years of age and weight at screening ≥ 40 kg * Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR). * Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19). Key

Exclusion criteria

* Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 \< 24 hours prior to study drug dosing. * Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN). * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 using Schwartz formula for individuals ≥ 1 year of age. * Creatinine above protocol specified thresholds for \< 1 year of age. * Positive pregnancy test at Screening only for female of child bearing potential. Note: If female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator. * On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)). Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	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.
Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	Treatment-emergent graded 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.
Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	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	Cmax is defined as maximum plasma concentration of drug. 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.
PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	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	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 Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.

Secondary

Measure	Time frame	Description
Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	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 assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs.
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Baseline, Day 10, and Day of Discharge (Day 10 or before)	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 assessment were done for the samples: nasal/oropharyngeal (OP) samples, nasopharyngeal (NP)/OP samples, endotracheal (ET) aspirates, and rectal/fecal swabs.
Bilirubin Concentrations in < 14-day-old Participants	From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	—
Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Day 10	Clinical improvement was defined as ≥ 1-point and ≥ 2-point improvement from Baseline clinical status or recovery or discharged alive on 7-point ordinal scale. Recovery was defined as an improvement from a Baseline score of 2 - 5 to a score of 6 or 7 or an improvement from a Baseline score of 6 to 7 on the ordinal scale. The ordinal scale was used for the assessment of the clinical status at a given day using a 7-point ordinal scale with an increasing score indicating improvement. Scale: 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 required ongoing medical care (other than RDV administration), 7=Not hospitalized. The 95% CI was based on the Clopper-Pearson method.
Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	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	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.
Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	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.
Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Day 10	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.
Time (Days) to Discharge From Hospital	From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)	Time to discharge was the duration from the first dose date to getting discharged from the hospital.
Number of Participants With Change From Baseline in Oxygenation Use	Day 10	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. Change from Baseline for participants with oxygenation use status as '3=High Flow Oxygen', '4=Low Flow Oxygen' and '5=Room Air' at Baseline.
Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Day 10	Mechanical ventilation 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.

Countries

Italy, Spain, United Kingdom, United States

Participant flow

Recruitment details

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

Pre-assignment details

60 participants were screened.

Participants by arm

Arm	Count
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.	12
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg 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.	12
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg 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.	12
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg 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.	12
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg 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.	3
RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg 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.	1
RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg 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.	1
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.	5
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG007
Overall Study	Death	1	0	0	0	0	1
Overall Study	Enrolled but Never Treated	0	0	0	0	1	0
Overall Study	Lost to Follow-up	0	0	1	1	0	0
Overall Study	Withdrew Consent	0	1	0	2	0	0

Baseline characteristics

Characteristic	Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Total	RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg
Age, Customized Adolescents (12-17 years)	12 Participants	16 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Age, Customized Children (2-11 years)	0 Participants	24 Participants	5 Participants	0 Participants	0 Participants	11 Participants	8 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants	13 Participants	0 Participants	0 Participants	12 Participants	1 Participants	0 Participants
Age, Customized Newborns (0-27 days)	0 Participants	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	23 Participants	3 Participants	0 Participants	3 Participants	7 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants	32 Participants	2 Participants	3 Participants	9 Participants	5 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 2	1 Participants	14 Participants	0 Participants	2 Participants	5 Participants	3 Participants	3 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 3	6 Participants	19 Participants	2 Participants	1 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 4	2 Participants	10 Participants	2 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 5	3 Participants	12 Participants	1 Participants	0 Participants	0 Participants	6 Participants	2 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 6	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Status (7-Point Ordinal Scale) Score Score 7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oxygen Support Status High Flow Oxygen	6 Participants	19 Participants	2 Participants	1 Participants	3 Participants	3 Participants	4 Participants
Oxygen Support Status Invasive Mechanical Ventilation Status	1 Participants	14 Participants	0 Participants	2 Participants	5 Participants	3 Participants	3 Participants
Oxygen Support Status Low Flow Oxygen	2 Participants	10 Participants	2 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Oxygen Support Status Room Air	3 Participants	13 Participants	1 Participants	0 Participants	1 Participants	6 Participants	2 Participants
Pediatric Early Warning Score (PEWS) Scale Score Behavior Score: 0	7 Participants	22 Participants	2 Participants	0 Participants	2 Participants	5 Participants	6 Participants
Pediatric Early Warning Score (PEWS) Scale Score Behavior Score: 1	3 Participants	13 Participants	1 Participants	1 Participants	3 Participants	2 Participants	3 Participants
Pediatric Early Warning Score (PEWS) Scale Score Behavior Score: 2	1 Participants	7 Participants	1 Participants	0 Participants	3 Participants	2 Participants	0 Participants
Pediatric Early Warning Score (PEWS) Scale Score Behavior Score: 3	1 Participants	14 Participants	1 Participants	2 Participants	4 Participants	3 Participants	3 Participants
Pediatric Early Warning Score (PEWS) Scale Score Cardiovascular Score: 0	9 Participants	34 Participants	2 Participants	1 Participants	8 Participants	7 Participants	7 Participants
Pediatric Early Warning Score (PEWS) Scale Score Cardiovascular Score: 1	1 Participants	12 Participants	3 Participants	2 Participants	1 Participants	3 Participants	2 Participants
Pediatric Early Warning Score (PEWS) Scale Score Cardiovascular Score: 2	2 Participants	4 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Pediatric Early Warning Score (PEWS) Scale Score Cardiovascular Score: 3	0 Participants	6 Participants	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants
Pediatric Early Warning Score (PEWS) Scale Score Respiratory Score: 0	4 Participants	17 Participants	2 Participants	0 Participants	4 Participants	6 Participants	1 Participants
Pediatric Early Warning Score (PEWS) Scale Score Respiratory Score: 1	2 Participants	10 Participants	0 Participants	1 Participants	0 Participants	2 Participants	5 Participants
Pediatric Early Warning Score (PEWS) Scale Score Respiratory Score: 2	3 Participants	11 Participants	1 Participants	0 Participants	3 Participants	2 Participants	2 Participants
Pediatric Early Warning Score (PEWS) Scale Score Respiratory Score: 3	3 Participants	18 Participants	2 Participants	2 Participants	5 Participants	2 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	5 Participants	14 Participants	1 Participants	0 Participants	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	6 Participants	1 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	7 Participants	36 Participants	3 Participants	3 Participants	8 Participants	6 Participants	9 Participants
Region of Enrollment Italy	0 participants	3 participants	1 participants	1 participants	1 participants	0 participants	0 participants
Region of Enrollment Spain	3 participants	9 participants	1 participants	0 participants	1 participants	3 participants	1 participants
Region of Enrollment United Kingdom	0 participants	1 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Region of Enrollment United States	9 participants	43 participants	3 participants	2 participants	9 participants	9 participants	11 participants
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Ribonucleic Acid (RNA) Viral Load Endotracheal Tube Aspirates	5.36 log10 copies per mL	5.87 log10 copies per mL STANDARD_DEVIATION 2.18	—	4.63 log10 copies per mL	6.68 log10 copies per mL STANDARD_DEVIATION 1.54	6.09 log10 copies per mL STANDARD_DEVIATION 0.84	5.58 log10 copies per mL STANDARD_DEVIATION 3.554
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Ribonucleic Acid (RNA) Viral Load Nasal/oropharyngeal Swabs	5.35 log10 copies per mL STANDARD_DEVIATION 1.796	4.80 log10 copies per mL STANDARD_DEVIATION 1.998	6.20 log10 copies per mL	5.02 log10 copies per mL	5.41 log10 copies per mL STANDARD_DEVIATION 2.165	3.18 log10 copies per mL STANDARD_DEVIATION 0.967	4.87 log10 copies per mL STANDARD_DEVIATION 2.807
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Ribonucleic Acid (RNA) Viral Load Nasopharyngeal/oropharyngeal Swabs	5.93 log10 copies per mL STANDARD_DEVIATION 2.172	5.78 log10 copies per mL STANDARD_DEVIATION 1.802	6.12 log10 copies per mL STANDARD_DEVIATION 1.628	5.99 log10 copies per mL STANDARD_DEVIATION 0.183	5.55 log10 copies per mL STANDARD_DEVIATION 1.854	5.67 log10 copies per mL STANDARD_DEVIATION 2.273	5.37 log10 copies per mL STANDARD_DEVIATION 1.879
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Ribonucleic Acid (RNA) Viral Load Rectal/fecal Swabs	3.30 log10 copies per mL STANDARD_DEVIATION 1.593	3.26 log10 copies per mL STANDARD_DEVIATION 1.297	2.75 log10 copies per mL STANDARD_DEVIATION 1.274	4.27 log10 copies per mL STANDARD_DEVIATION 1.107	3.84 log10 copies per mL STANDARD_DEVIATION 1.341	2.72 log10 copies per mL STANDARD_DEVIATION 1.034	2.63 log10 copies per mL STANDARD_DEVIATION 0.757
Sex: Female, Male Female	8 Participants	31 Participants	3 Participants	1 Participants	7 Participants	5 Participants	7 Participants
Sex: Female, Male Male	4 Participants	25 Participants	2 Participants	2 Participants	5 Participants	7 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	2 / 12	1 / 12	0 / 12	0 / 12	0 / 4	0 / 0	0 / 0	1 / 5
other Total, other adverse events	11 / 12	7 / 12	9 / 12	7 / 12	2 / 3	0 / 0	0 / 0	4 / 5
serious Total, serious adverse events	5 / 12	2 / 12	0 / 12	3 / 12	1 / 3	0 / 0	0 / 0	1 / 5

Outcome results

Primary

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

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.

Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: 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.

Arm	Measure	Value (NUMBER)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	91.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	58.3 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	75.0 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	58.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	80.0 percentage of participants

Primary

Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities

Treatment-emergent graded 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.

Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation were analyzed. 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.

Arm	Measure	Group	Value (NUMBER)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	100 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	75 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	83.3 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	16.7 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	91.7 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	41.7 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	90.9 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	36.4 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	100 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	100 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Any grade	80 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities	Grade 3 or 4	60 percentage of participants

Primary

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

Cmax is defined as maximum plasma concentration of drug. 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.

Time frame: 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

Population: 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.~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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	360.6 ng/mL	Standard Deviation 208.11
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	4108.7 ng/mL	Standard Deviation 1365.15
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	276.4 ng/mL	Standard Deviation 327.14
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	469.0 ng/mL	Standard Deviation 239.72
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	6003.5 ng/mL	Standard Deviation 1879.86
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	210.5 ng/mL	Standard Deviation 121.02
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	484.8 ng/mL	Standard Deviation 244.07
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	5980.1 ng/mL	Standard Deviation 2284.08
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	186.5 ng/mL	Standard Deviation 103.09
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	407.8 ng/mL	Standard Deviation 132.45
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	5192.9 ng/mL	Standard Deviation 2066.65
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	209.8 ng/mL	Standard Deviation 49.73
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	466.0 ng/mL	Standard Deviation 110.87
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	4829.0 ng/mL	Standard Deviation 956.16
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	371.8 ng/mL	Standard Deviation 151.1
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	4235.7 ng/mL	Standard Deviation 1790.53
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	230.4 ng/mL	Standard Deviation 255.03
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	297.9 ng/mL	Standard Deviation 160.18

Primary

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

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 Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.

Arm	Measure	Group	Value (MEAN)	Dispersion
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	1222.9 h*ng/mL	Standard Deviation 1348.12
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	2630.1 h*ng/mL	Standard Deviation 923.85
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	5486.2 h*ng/mL	Standard Deviation 7599.27
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	860.3 h*ng/mL	Standard Deviation 512.58
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	3937.9 h*ng/mL	Standard Deviation 1981.4
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	3016.1 h*ng/mL	Standard Deviation 2425.78
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	876.0 h*ng/mL	Standard Deviation 720.39
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	6752.1 h*ng/mL	Standard Deviation 10911.98
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	2751.8 h*ng/mL	Standard Deviation 1868.93
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	776.0 h*ng/mL	Standard Deviation 485.18
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	3625.7 h*ng/mL	Standard Deviation 3361.19
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	2969.1 h*ng/mL	Standard Deviation 940.73
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	1049.0 h*ng/mL	Standard Deviation 253.73
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	2650.3 h*ng/mL	Standard Deviation 587.77
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	6899.3 h*ng/mL	Standard Deviation 3910.28
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	Remdesivir	2519.6 h*ng/mL	Standard Deviation 1235.49
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-441524	4336.8 h*ng/mL	Standard Deviation 5692.3
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State	GS-704277	671.4 h*ng/mL	Standard Deviation 553.3

Secondary

Bilirubin Concentrations in < 14-day-old Participants

Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: 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.

Secondary

Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result

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 assessment were done for the samples: nasal/oropharyngeal (OP) samples, nasopharyngeal (NP)/OP samples, endotracheal (ET) aspirates, and rectal/fecal swabs.

Time frame: Baseline, Day 10, and Day of Discharge (Day 10 or before)

Population: 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.~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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Day 10	-3.01 log10 copies per mL	—
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Day 10	0.38 log10 copies per mL	—
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Discharge	-2.86 log10 copies per mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Day 10	-2.17 log10 copies per mL	Standard Deviation 2.197
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	ET aspirates, Change at Day 10	-5.94 log10 copies per mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Discharge	-4.65 log10 copies per mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Discharge	-3.72 log10 copies per mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Day 10	-0.39 log10 copies per mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Discharge	1.12 log10 copies per mL	—
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Day 10	0 log10 copies per mL	Standard Deviation 0
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Discharge	-0.09 log10 copies per mL	Standard Deviation 1.999
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Discharge	-0.87 log10 copies per mL	Standard Deviation 1.391
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Discharge	1.42 log10 copies per mL	—
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Discharge	-1.56 log10 copies per mL	Standard Deviation 1.228
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Day 10	-2.60 log10 copies per mL	Standard Deviation 1.283
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Discharge	-1.47 log10 copies per mL	Standard Deviation 0.479
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Day 10	-1.87 log10 copies per mL	—
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Day 10	-3.28 log10 copies per mL	Standard Deviation 0.183
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Day 10	-2.36 log10 copies per mL	—
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	ET aspirates, Change at Day 10	-1.92 log10 copies per mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Nasal/OP Samples, Change at Day 10	-1.76 log10 copies per mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Day 10	0.46 log10 copies per mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	NP/OP Samples, Change at Discharge	-0.05 log10 copies per mL	Standard Deviation 1.184
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Day 10	1.38 log10 copies per mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result	Rectal or Fecal Swabs, Change at Discharge	0 log10 copies per mL	Standard Deviation 0

Secondary

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

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 assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs.

Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: The Full 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 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.

Arm	Measure	Group	Value (MEDIAN)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	ET aspirates	NA days
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	NA days
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	5 days
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	5 days
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	ET aspirates	NA days
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	3 days
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	5 days
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	7 days
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	ET aspirates	NA days
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	7 days
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	NA days
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	ET aspirates	NA days
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	ET aspirates	NA days
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	10 days
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	3 days
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Rectal/Faecal samples	4 days
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	Nasal/OP Samples	NA days
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result	NP/OP Samples	NA days

Secondary

Number of Participants With Change From Baseline in Oxygenation Use

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. Change from Baseline for participants with oxygenation use status as '3=High Flow Oxygen', '4=Low Flow Oxygen' and '5=Room Air' at Baseline.

Time frame: Day 10

Population: Participants in Full Analysis Set with Oxygenation use status as 'High Flow Oxygen', 'Low Flow Oxygen' and 'Room Air' at Baseline were analyzed. Number analyzed are participants applicable for the specific categories.~Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there were only 1 participant in each of these groups.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	1 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	2 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	2 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	1 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	1 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	2 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	1 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	1 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	3 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	2 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	4 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	3 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	6 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	2 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	1 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	1 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	1 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	2 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	1 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	High Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Discharge (Day 10)	1 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Discharge (Day 10)	1 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Missing (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Low Flow oxygen (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Low Flow Oxygen (Baseline)	Room Air (Day 10)	1 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Discharge (Day 10)	1 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	Death (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	Room Air (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	Room Air (Baseline)	IMV (Day 10)	0 Participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Number of Participants With Change From Baseline in Oxygenation Use	High flow oxygen (Baseline)	IMV (Day 10)	1 Participants

Secondary

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

Mechanical ventilation 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.

Time frame: Day 10

Population: Participants in Full Analysis Set with Oxygenation use status as 'Mechanical Ventilation or ECMO' at Baseline were analyzed.~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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Low Flow Oxygen	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	High Flow Oxygen	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Death	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Missing	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Discharge	0 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Invasive Mechanical ventilation	1 Participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Room Air	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Invasive Mechanical ventilation	1 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Death	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	High Flow Oxygen	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Low Flow Oxygen	1 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Room Air	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Discharge	0 Participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Missing	1 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Invasive Mechanical ventilation	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Death	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	High Flow Oxygen	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Room Air	1 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Low Flow Oxygen	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Missing	0 Participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Discharge	2 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Low Flow Oxygen	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Death	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Missing	1 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Room Air	2 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Discharge	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	High Flow Oxygen	0 Participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Invasive Mechanical ventilation	2 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	High Flow Oxygen	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Low Flow Oxygen	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Room Air	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Death	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Missing	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Discharge	0 Participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Invasive Mechanical ventilation	2 Participants

Secondary

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

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.

Time frame: Day 10

Population: 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.~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.

Arm	Measure	Group	Value (NUMBER)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	40 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	37.5 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	0 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	0 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	33.3 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	40 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Cardiovascular	0 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	33.3 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	50.0 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	66.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	81.8 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Cardiovascular	66.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	83.3 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	80 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	33.3 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	66.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	81.8 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	80 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	100 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	83.3 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	100 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	75.0 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	100 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	100 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	100 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	83.3 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Cardiovascular	100 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	66.7 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	42.9 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	42.9 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Cardiovascular	100 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	33.3 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	42.9 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	66.7 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	55.6 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	66.7 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	50 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	50 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	66.7 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	33.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	33.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	0 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	33.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	0 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Cardiovascular	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Behavior	33.3 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Behavior	33 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	Recovery- Respiratory	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Respiratory	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Cardiovascular	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 1-point Improvement from Baseline- Respiratory	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale	≥ 2-point Improvement from Baseline- Behavior	50 percentage of participants

Secondary

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

Clinical improvement was defined as ≥ 1-point and ≥ 2-point improvement from Baseline clinical status or recovery or discharged alive on 7-point ordinal scale. Recovery was defined as an improvement from a Baseline score of 2 - 5 to a score of 6 or 7 or an improvement from a Baseline score of 6 to 7 on the ordinal scale. The ordinal scale was used for the assessment of the clinical status at a given day using a 7-point ordinal scale with an increasing score indicating improvement. Scale: 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 required ongoing medical care (other than RDV administration), 7=Not hospitalized. The 95% CI was based on the Clopper-Pearson method.

Time frame: Day 10

Population: The Full 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.

Arm	Measure	Group	Value (NUMBER)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	41.7 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	50.0 percentage of participants
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	25.0 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	91.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	91.7 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	75.0 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	100.0 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	100.0 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	91.7 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	54.5 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	58.3 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	41.7 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	33.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	33.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	33.3 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 1-point Improvement from Baseline	80.0 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	Recovery	80.0 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score	≥ 2-point Improvement from Baseline	80.0 percentage of participants

Secondary

Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19

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.

Time frame: first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: 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.

Arm	Measure	Value (NUMBER)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	100.0 percentage of participants
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	100.0 percentage of participants
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	83.3 percentage of participants
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	83.3 percentage of participants
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	66.7 percentage of participants
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19	100.0 percentage of participants

Secondary

Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)

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.

Population: 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.~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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	78.5 ug/mL	Standard Deviation 209.65
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	217.7 ug/mL	Standard Deviation 262.32
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, 6 Hours post infusion	141.2 ug/mL	Standard Deviation 261.96
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	90.1 ug/mL	Standard Deviation 221.54
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	110.1 ug/mL	Standard Deviation 270.72
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, Middle of Infusion	229.0 ug/mL	Standard Deviation 221.14
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, 6 Hours post infusion	6.6 ug/mL	Standard Deviation 3.15
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	47.5 ug/mL	Standard Deviation 52.62
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	24.3 ug/mL	Standard Deviation 23.9
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	173.0 ug/mL	Standard Deviation 119.06
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	NA ug/mL	—
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, Middle of Infusion	105.5 ug/mL	Standard Deviation 72.05
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	NA ug/mL	—
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	14.2 ug/mL	Standard Deviation 15.03
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, Middle of Infusion	156.3 ug/mL	Standard Deviation 23.12
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	47.4 ug/mL	Standard Deviation 38.99
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	187.8 ug/mL	Standard Deviation 75.89
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, 6 Hours post infusion	NA ug/mL	—
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	36.2 ug/mL	Standard Deviation 32.75
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	NA ug/mL	—
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	58.2 ug/mL	Standard Deviation 25.89
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, Middle of Infusion	118.2 ug/mL	Standard Deviation 121.22
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	138.3 ug/mL	Standard Deviation 104.06
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, 6 Hours post infusion	12.4 ug/mL	Standard Deviation 9.89
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	NA ug/mL	—
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	61.0 ug/mL	Standard Deviation 79.2
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	NA ug/mL	—
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	NA ug/mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, Pre-Infusion	NA ug/mL	—
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, Middle of Infusion	184.2 ug/mL	Standard Deviation 131.82
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, 4 hours post infusion	16.2 ug/mL	Standard Deviation 8.31
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 2, End of Infusion	156.6 ug/mL	Standard Deviation 57.21
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 3, 2 hours post infusion	48.0 ug/mL	Standard Deviation 50.41
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)	Day 5, 6 Hours post infusion	NA ug/mL	—

Secondary

Time (Days) to Discharge From Hospital

Time to discharge was the duration from the first dose date to getting discharged from the hospital.

Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)

Population: The participants in the Full Analysis Set who were discharged alive on or prior to Day 30 were analyzed.~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.

Arm	Measure	Value (MEDIAN)
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg	Time (Days) to Discharge From Hospital	12 days
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg	Time (Days) to Discharge From Hospital	7 days
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg	Time (Days) to Discharge From Hospital	5 days
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg	Time (Days) to Discharge From Hospital	7 days
RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg	Time (Days) to Discharge From Hospital	NA days
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg	Time (Days) to Discharge From Hospital	10 days

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026

Study of Remdesivir in Participants Below 18 Years Old With COVID-19

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities

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

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

Bilirubin Concentrations in < 14-day-old Participants

Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result

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

Number of Participants With Change From Baseline in Oxygenation Use

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

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

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

Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19

Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)

Time (Days) to Discharge From Hospital