A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Shionogi
Study ID
NCT07743580
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
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 primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 6, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause Deaths [ Time Frame: Baseline through Day 28 ]

Central Contacts

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

Locations (8)

FacilityCityStateZIPSite coordinators
Hope Clinical Trials - 3970 W Flagler St.Coral GablesFlorida33134-1642-
Continental Clinical Research, LLCMiamiFlorida33144-4273-
Kendall South Medical Center Inc.MiamiFlorida33185-5948-
Reed Medical ResearchMiamiFlorida33176-8709-
Global Clinical ProfessionalsSt. PetersburgFlorida33705-
New Tampa HealthTampaFlorida33603-3402-
Research Bay, Inc.TampaFlorida33607-
Hometown Urgent Care and ResearchCincinnatiOhio45215-1170-

Find similar trials in Coral Gables, FL

Nationwide
COVID-19 / long COVID trialsInfectious disease trials
By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Hope Clinical Trials - 3970 W Flagler St.· Coral Gables, FLContinental Clinical Research, LLC· Miami, FLKendall South Medical Center Inc.· Miami, FLReed Medical Research· Miami, FLGlobal Clinical Professionals· St. Petersburg, FLNew Tampa Health· Tampa, FL

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