COVID-19-Infection
Conditions
Sponsors
Gilead Sciences, K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2)4.8.15 emergency use provisions as deemed necessary by the investigator (participants >= 18 years of age), or willing and able to provide assent (participants >= 12 and = 12 and = 18 years (at all sites), or aged >= 12 and = 40kg (where permitted according to local law and approved nationally and by the relevant institutional review board(IRB) or independent ethics committee (IEC)) -SARS-CoV-2 infection confirmed by PCR test =< 4 days before randomization -Currently hospitalized -SpO2 =< 94% on room air or requiring supplemental oxygen at screening -Radiographic evidence of pulmonary infiltrates
Exclusion criteria
Exclusion criteria: -Participation in any other clinical trial of an experimental treatment for COVID-19 -Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 = 5 days,or any duration of V-A ECMO -ALT or AST > 5 X ULN -Creatinine clearance = 18 years of age (Cockcroft 1976) and Schwartz Formula for participants < 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Clinical status assessed by a 7-point ordinal scale on Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed