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

JRCT ID: jRCT2031220645

Registered date:17/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Infectious disease caused by the SARS-CoV-2
• Date of first enrollment: 01/03/2023
• Target sample size: 2300
• Countries of recruitment: Brazil,Japan,Bulgaria,Japan,Canada,Japan,Czech Republic,Japan,France,Japan,Hungary,Japan,India,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Singapore,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Turkey,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Proportion of COVID-19 related hospitalization or all-cause death by Day 29

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ueda Hiroki
• Secondary ID(s): NCT05603143