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

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/Exclusion criteria may apply