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

Conditions

• SARS-CoV-2

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

Sep 14, 2026

Status verified

Sep 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)

Find similar trials in Coral Gables, FL

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