Study of GS-5245 in Nonhospitalized Participants With COVID-19

JRCT ID: jRCT2031230285

Registered date:10/08/2023

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: 31/08/2033
• Target sample size: 1900
• Countries of recruitment: US,Japan,Canada,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: Time to COVID 19 symptom alleviation by Day 29

Secondary Outcome

Time to COVID-19 symptom resolution by Day 29
Proportion of participants with COVID19 related MAVs or all cause death by Day 29
Proportion of participants with moderate relapse of COVID19 symptoms by Day 29
Proportion of participants with COVID19 related hospitalization or all cause death by Day 29
Change from baseline in SARS CoV 2 nasal swab viral load at Day 5
Time to antigen negativity
Proportion of participants with viral antigen rebound
Plasma concentrations and PK parameters AUCtau, Ctau, and Cmax of GS 441524, as available
Proportion of participants with relapse of COVID19 symptoms by Day 29

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old

Include criteria

Aged 18 to 65 years
Willing and able to provide written informed consent.
SARS CoV 2 infection confirmed, 3 days before randomization
Initial onset of COVID19 signs/symptoms 3 days before randomization
Not currently hospitalized or requiring hospitalization.

Exclude criteria

Any risk factors for progression to severe disease.
Received an approved, authorized, or investigational COVID-19 vaccine (including booster dose) < 120 days before randomization.
Self-reported COVID-19 diagnosis < 120 days before randomization.
Anticipated need for hospitalization < 48 hours after randomization.
Positive urine pregnancy test at screening.

Related Information

• Primary Sponsor: Ueda Hiroki
• Secondary ID(s): NCT05715528