Study of Secutrelvir in Participants With COVID-19

Sponsor
Shionogi
Study ID
NCT07746544
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Secutrelvir — DRUG
    Secutrelvir will be administered orally as a tablet.
  • Placebo — DRUG
    Placebo will be administered orally as a tablet.

Study Details

The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 5, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secutrelvir
    Participants will receive secutrelvir administered orally.
  • Placebo Comparator: Placebo
    Participants will receive placebo administered orally.

Primary Outcome Measure

Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [ Time Frame: Baseline through Day 21 ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    1-800-849-9707
    [email protected]

Find similar trials

Nationwide
COVID-19 / long COVID trialsInfectious disease trials

Related Studies