Study Evaluating GS-5245 in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression (BIRCH study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220645

Enrollment

2300

Registered

2023-02-17

Start date

2023-03-01

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

Infectious disease caused by the SARS-CoV-2 COVID19

Interventions

Experimental: GS-5245 Participants will receive GS-5245 350 mg twice daily for 5 days. Placebo Comparator: Placebo Participants will receive GS-5245 placebo twice daily for 5 days.

Eligibility

Inclusion criteria

Inclusion criteria: - Willing and able to provide written informed consent. - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed with an assay 5 days before randomization. - Initial onset of COVID-19 signs or symptoms 5 days before randomization. - Not currently hospitalized or requiring hospitalization. - Presence of 1 risk factor (if unvaccinated) or 2 risk factors (if vaccinated at any point) for progression to severe disease. Vaccinated individuals are eligible for enrollment only if it has been at least 4 months since the most recent dose, including boosters.

Exclusion criteria

Exclusion criteria: - Anticipated use of COVID-19 therapies during the current COVID-19 illness. - Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization. - Anticipated need for hospitalization < 48 hours after randomization. - New oxygen requirement < 24 hours before randomization. - Cirrhosis or acute liver injury/failure. - Undergoing dialysis, or history of moderate to severe renal impairment. - Pregnant or breastfeeding (nursing). - Unwilling to use protocol-mandated birth control.

Design outcomes

Primary

Measure	Time frame
Proportion of COVID-19 related hospitalization or all-cause death by Day 29	—

Secondary

Measure	Time frame
- Incidence of treatment emergent AEs and laboratory abnormalities - Proportion of participants with all cause hospitalization by Day 29 - Proportion of participants with COVID19 related MAVs or all cause death by Day 29 - Proportion of participants with COVID19 related MAVs by Day 29 - Proportion of participants with all cause death at Day 29 - Time to sustained alleviation of targeted COVID19 symptoms - Change from baseline in SARS-CoV-2 viral load at Day 5	—

Measure

Time frame

- Incidence of treatment emergent AEs and laboratory abnormalities - Proportion of participants with all cause hospitalization by Day 29 - Proportion of participants with COVID19 related MAVs or all cause death by Day 29 - Proportion of participants with COVID19 related MAVs by Day 29 - Proportion of participants with all cause death at Day 29 - Time to sustained alleviation of targeted COVID19 symptoms - Change from baseline in SARS-CoV-2 viral load at Day 5

—

Countries

Brazil, Bulgaria, Canada, Czech Republic, France, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Romania, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, UK

Contacts

Public ContactOperations Clinical

Gilead Sciences

JPClinicalOperations@gilead.com+81-3-5539-1946

Outcome results

None listed

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