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NCT07743580PHASE3Recruiting

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

Shionogi

Start Date

9/14/2026

Completion Date

12/31/2028

Summary

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.

Eligibility Criteria

Age Range: 12 years to No maximum

Key Inclusion Criteria: * Must be 12 to \<18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form. * Presence of risk factors for progression to severe COVID-19 at the time of screening. * Must have ≥1 COVID-19 signs/symptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization. * Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization. * Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention. * Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir/ritonavir, molnupiravir, remdesivir, ensitrelvir). Key Exclusion Criteria: * Planned \>24 hours hospitalization for any medical procedure through Day 28. * Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit. * Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). * Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit): * Total bilirubin ≥2\*upper limit of normal (ULN) (except for Gilbert's syndrome) * Aspartate aminotransferase or alanine aminotransferase ≥3\*ULN * Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization. * Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention. * Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis. * Current severely immunocompromised conditions. * Received any other COVID-19-specific therapies within the following timeframes: * Antiviral agents (for example, remdesivir, nirmatorelvir/ritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization * Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization Note: Other protocol-define criteria apply

Interventions

DRUG

Secutrelvir

DRUG

Placebo

Interested in This Trial?

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Conditions

SARS-CoV-2

Locations

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida 33134-1642

United States

Continental Clinical Research, LLC

Miami, Florida 33144-4273

United States

Reed Medical Research

Miami, Florida 33176-8709

United States

Kendall South Medical Center Inc.

Miami, Florida 33185-5948

United States

Global Clinical Professionals

St. Petersburg, Florida 33705

United States

New Tampa Health

Tampa, Florida 33603-3402

United States

Research Bay, Inc.

Tampa, Florida 33607

United States

Hometown Urgent Care and Research

Cincinnati, Ohio 45215-1170

United States

Medical Center Unimed EOOD

Sevlievo, Gabrovo 5402

Bulgaria

Medichi Sofia - Medical Center OOD

Sofia, Sofia 1113

Bulgaria

MCpulmo-2018 Ltd

Haskovo, 6300

Bulgaria

Medical Center Medconsult Pleven - Lovech Branch

Lovech, 5500

Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, 5800

Bulgaria

Abe Shun Naika Clinic

Kasugai-Shi, Aiti 815-0074

Japan

Chiba Aoba Municipal Hospital

Chiba, Chiba 206-0852

Japan

Japan Community Health Care Organization Nihonmatsu Hospital

Nihommatsu, Fukushima 964-8501

Japan

Shinozuka Hospital

Fujioka-Shi, Gunma 375-0017

Japan

Shizuka Medical Clinic

Koyagimachi, Gunma 370-0071

Japan

Kikuchi Clinic

Maebashi, Gunma 370-3573

Japan

Tsuchiura Beryl Clinic

Takasaki-shi, Gunma 300-0062

Japan

Toda Internal Medicine & Neurology

Akashi-Shi, Hyôgo 674-0081

Japan

Terada Clinic Respiratory Medicine and General Practice

Himeji-shi, Hyôgo 670-0849

Japan

Kamezawa Clinic

Tsuchiura-Shi, Ibaraki 486-0817

Japan

Sato Clinic

Kawasaki-shi, Kanagawa 150-0013

Japan

Shinjo Terasu Clinic

Kawasaki-shi, Kanagawa 211-0044

Japan

Shibasaki Internal Medicine and Pediatrics Clinic

Sendai, Miyagi 980-0871

Japan

Matsuo Kenko Clinic

Sendai, Miyagi 981-0907

Japan

Sugiura Clinic

Kawaguchi-shi, Saitama 332-0012

Japan

Tokyo Center Clinic

Chuo-Ku, Tokyo 103-0027

Japan

Nishikasai ekimae Clinic

Edogawa-ku, Tokyo 134-0088

Japan

Hosoda Clinic

Katsushika-ku, Tokyo 124-0021

Japan

Morishita Ekimae Clinic

Koto-ku, Tokyo 135-0004

Japan

Shizuka Medicine Clinic

Musashino, Tokyo 370-0071

Japan

Nogata Clinic

Nakano-ku, Tokyo 165-0027

Japan

Miura Ken Clinic

Ōta-ku, Tokyo 114-0046

Japan

Yotsuya Naika

Shibuya-Ku, Tokyo 160-0017

Japan

Medical Corporation Shirayurikai Swing Nozaki Clinic

Shinjuku-Ku, Tokyo 180-0022

Japan

Okura ENT Clinic

Toshima-ku, Tokyo 170-0005

Japan

Tomita Internal Medicine Clinic

Fukuoka, 810-0033

Japan