Ireland
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Recruiting Phase 3

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

NCT07743580 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2026-09-14
Last updated
2026-11-03

Condition(s) studied

SARS-CoV-2

Investigational drug(s) / intervention(s)

Secutrelvir →Placebo

Secutrelvir: Secutrelvir will be administered orally as a tablet.

Placebo: Placebo will be administered orally as a tablet.

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (51)

FacilityCityRegionStatus
Hope Clinical Trials - 3970 W Flagler St. Coral Gables Florida Not Yet Recruiting
Las Mercedes Medical Research Hialeah Florida Recruiting
Continental Clinical Research, LLC Miami Florida Recruiting
Reed Medical Research Miami Florida Not Yet Recruiting
Kendall South Medical Center Inc. Miami Florida Not Yet Recruiting
Oceanic Research Group North Miami Beach Florida Recruiting
Global Clinical Professionals St. Petersburg Florida Not Yet Recruiting
New Tampa Health Tampa Florida Not Yet Recruiting
Research Bay, Inc. Tampa Florida Not Yet Recruiting
Hometown Urgent Care and Research Cincinnati Ohio Not Yet Recruiting
Velocity Clinical Research Cincinnati Ohio Recruiting
Medical Center Unimed EOOD Sevlievo Gabrovo Not Yet Recruiting
Medichi Sofia - Medical Center OOD Sofia Sofia Not Yet Recruiting
MCpulmo-2018 Ltd Haskovo Bulgaria Not Yet Recruiting
Medical Center Medconsult Pleven - Lovech Branch Lovech Bulgaria Not Yet Recruiting
Medical Center Medconsult Pleven OOD Pleven Bulgaria Not Yet Recruiting
Abe Shun Naika Clinic Kasugai-Shi Aiti Recruiting
Chiba Aoba Municipal Hospital Chiba Chiba Recruiting
NHO Fukuoka Hospital Fukuoka Fukuoka Recruiting
Japan Community Health Care Organization Nihonmatsu Hospital Nihommatsu Fukushima Not Yet Recruiting
Yujin Suto Annaka-Shi Gunma Recruiting
Shinozuka Hospital Fujioka-Shi Gunma Recruiting
Shizuka Medical Clinic Koyagimachi Gunma Recruiting
Kikuchi Clinic Maebashi Gunma Recruiting
Tsuchiura Beryl Clinic Takasaki-shi Gunma Recruiting
Toda Internal Medicine & Neurology Akashi-Shi Hyôgo Recruiting
Terada Clinic Respiratory Medicine and General Practice Himeji-shi Hyôgo Recruiting
Kamezawa Clinic Tsuchiura-Shi Ibaraki Recruiting
University of Tsukuba Hospital Tsukuba Ibaraki Recruiting
Hirano Clinic Morioka Iwate Recruiting
Sato Clinic Kawasaki-shi Kanagawa Recruiting
Shinjo Terasu Clinic Kawasaki-shi Kanagawa Recruiting
Omi Medical Center Shiga Kusatsu Recruiting
Shibasaki Internal Medicine and Pediatrics Clinic Sendai Miyagi Recruiting
Matsuo Kenko Clinic Sendai Miyagi Recruiting
NHO Nagasaki Medical Cente Omura-Shi Nagasaki Recruiting
Saga Memorial Hospital, Saga Saga-ken Recruiting
Sugiura Clinic Kawaguchi-shi Saitama Recruiting
Tokyo Center Clinic Chuo-Ku Tokyo Recruiting
Nishikasai ekimae Clinic Edogawa-ku Tokyo Recruiting

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07743580 on ClinicalTrials.gov ↗ ← All trials in the USA