A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225160

Enrollment

1600

Registered

2020-04-10

Start date

2020-04-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

COVID-19-Infection

Interventions

investigational material(s) Generic name etc : Remdesivir INN of investigational material : remdesivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Willing and able to provide written informed consent (participants >= 18 years of age) or assent (participants >= 12 and = 12 and = 18 years (at all sites), or aged >= 12 and = 40 kg (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 = 94% on room air at screening -Radiographic evidence of pulmonary infiltrates

Exclusion criteria

Exclusion criteria: -Participation in any other clinical trial of an experimental agent treatment for COVID-19 -Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 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 11	—

Secondary

Measure	Time frame
safety The 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

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026