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

NCT07743580 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2513T1632
• Study Type: interventional
• Target: 2,000
• Locations: 3 countries
• Sites: 27

Brief 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.

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2; COVID-19; Secutrelvir; S-892216

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Day 28

Secondary Outcomes (15)

• Time to Sustained Resolution of 14 COVID-19 Symptoms

  Baseline through Day 28

• Proportion of Participants with tMAVs Due to Worsening COVID-19

  Baseline through Day 28

• Proportion of Participants with All-cause Hospitalization or All-cause Death

  Baseline through Day 28

• Proportion of Participants with Hospitalization Due to Worsening COVID-19

  Baseline through Day 28

• Time to First Resolution of 14 COVID-19 Symptoms

  Baseline through Day 28

Study Arms (2)

Secutrelvir

EXPERIMENTAL

Participants will receive secutrelvir.

Drug: Secutrelvir

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

Secutrelvir DRUG

Secutrelvir will be administered orally as a tablet.

Also known as: S-892216

Secutrelvir

Placebo DRUG

Placebo will be administered orally as a tablet.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (27)

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida, 33134-1642, United States

Location

Continental Clinical Research, LLC

Miami, Florida, 33144-4273, United States

Location

Reed Medical Research

Miami, Florida, 33176-8709, United States

Location

Kendall South Medical Center Inc.

Miami, Florida, 33185-5948, United States

Location

Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

Location

New Tampa Health

Tampa, Florida, 33603-3402, United States

Location

Research Bay, Inc.

Tampa, Florida, 33607, United States

Location

Hometown Urgent Care and Research

Cincinnati, Ohio, 45215-1170, United States

Location

Medical Center Unimed EOOD

Sevlievo, Gabrovo, 5402, Bulgaria

Location

Medichi Sofia - Medical Center OOD

Sofia, Sofia, 1113, Bulgaria

Location

MCpulmo-2018 Ltd

Haskovo, 6300, Bulgaria

Location

Medical Center Medconsult Pleven - Lovech Branch

Lovech, 5500, Bulgaria

Location

Medical Center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

Location

Abe Shun Naika Clinic

Kasugai-Shi, Aiti, 815-0074, Japan

Location

Chiba Aoba Municipal Hospital

Chiba, Chiba, 206-0852, Japan

Location

Japan Community Health Care Organization Nihonmatsu Hospital

Nihommatsu, Fukushima, 964-8501, Japan

Location

Tsuchiura Beryl Clinic

Takasaki-shi, Gunma, 300-0062, Japan

Location

Toda Internal Medicine & Neurology

Akashi-Shi, Hyôgo, 674-0081, Japan

Location

Terada Clinic Respiratory Medicine and General Practice

Himeji-shi, Hyôgo, 670-0849, Japan

Location

Kamezawa Clinic

Tsuchiura-Shi, Ibaraki, 486-0817, Japan

Location

Sato Clinic

Kawasaki-shi, Kanagawa, 150-0013, Japan

Location

Shibasaki Internal Medicine and Pediatrics Clinic

Sendai, Miyagi, 980-0871, Japan

Location

Tokyo Center Clinic

Chuo-Ku, Tokyo, 103-0027, Japan

Location

Shizuka Medicine Clinic

Musashino, Tokyo, 370-0071, Japan

Location

Yotsuya Naika

Shibuya-Ku, Tokyo, 160-0017, Japan

Location

Medical Corporation Shirayurikai Swing Nozaki Clinic

Shinjuku-Ku, Tokyo, 180-0022, Japan

Location

Tomita Internal Medicine Clinic

Fukuoka, 810-0033, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Shionogi Inc.

  STUDY DIRECTOR

Central Study Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

1-800-849-9707; Shionogiclintrials-admin@shionogi.co.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 6, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (14); BU (5); US (8)