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Can a new pill keep High-Risk COVID-19 patients out of the hospital?

NCT ID NCT07743580

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This phase 3 trial is testing whether the oral antiviral secutrelvir can prevent severe COVID-19 in people who are at high risk for complications. Participants with mild symptoms and confirmed SARS-CoV-2 infection will receive either secutrelvir or a placebo. The study will measure how many experience medically attended visits, hospitalizations, or deaths due to worsening COVID-19, as well as how quickly symptoms resolve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
secutrelvir (an antiviral drug taken as a pill)
What this could lead to
If successful, secutrelvir could offer a new oral treatment to prevent severe COVID-19 in people at high risk, potentially reducing hospitalizations and deaths.
What could go wrong
This is a phase 3 trial, but results are not guaranteed. The drug may not prove more effective than placebo, and safety concerns could emerge. Its benefit in the current COVID-19 landscape is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abe Shun Naika Clinic

    RECRUITING

    Kasugai-Shi, Aiti, 815-0074, Japan

  • Chiba Aoba Municipal Hospital

    NOT_YET_RECRUITING

    Chiba, Chiba, 206-0852, Japan

  • Continental Clinical Research, LLC

    NOT_YET_RECRUITING

    Miami, Florida, 33144-4273, United States

  • Global Clinical Professionals

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Hometown Urgent Care and Research

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45215-1170, United States

  • Hope Clinical Trials - 3970 W Flagler St.

    NOT_YET_RECRUITING

    Coral Gables, Florida, 33134-1642, United States

  • Japan Community Health Care Organization Nihonmatsu Hospital

    NOT_YET_RECRUITING

    Nihommatsu, Fukushima, 964-8501, Japan

  • Kamezawa Clinic

    RECRUITING

    Tsuchiura-Shi, Ibaraki, 486-0817, Japan

  • Kendall South Medical Center Inc.

    NOT_YET_RECRUITING

    Miami, Florida, 33185-5948, United States

  • Kikuchi Clinic

    RECRUITING

    Maebashi, Gunma, 370-3573, Japan

  • MCpulmo-2018 Ltd

    NOT_YET_RECRUITING

    Haskovo, 6300, Bulgaria

  • Matsuo Kenko Clinic

    RECRUITING

    Sendai, Miyagi, 981-0907, Japan

  • Medical Center Medconsult Pleven - Lovech Branch

    NOT_YET_RECRUITING

    Lovech, 5500, Bulgaria

  • Medical Center Medconsult Pleven OOD

    NOT_YET_RECRUITING

    Pleven, 5800, Bulgaria

  • Medical Center Unimed EOOD

    NOT_YET_RECRUITING

    Sevlievo, Gabrovo, 5402, Bulgaria

  • Medical Corporation Shirayurikai Swing Nozaki Clinic

    RECRUITING

    Shinjuku-Ku, Tokyo, 180-0022, Japan

  • Medichi Sofia - Medical Center OOD

    NOT_YET_RECRUITING

    Sofia, Sofia, 1113, Bulgaria

  • Morishita Ekimae Clinic

    RECRUITING

    Koto-ku, Tokyo, 135-0004, Japan

  • New Tampa Health

    NOT_YET_RECRUITING

    Tampa, Florida, 33603-3402, United States

  • Nishikasai ekimae Clinic

    RECRUITING

    Edogawa-ku, Tokyo, 134-0088, Japan

  • Okura ENT Clinic

    RECRUITING

    Toshima-ku, Tokyo, 170-0005, Japan

  • Reed Medical Research

    NOT_YET_RECRUITING

    Miami, Florida, 33176-8709, United States

  • Research Bay, Inc.

    NOT_YET_RECRUITING

    Tampa, Florida, 33607, United States

  • Sato Clinic

    RECRUITING

    Kawasaki-shi, Kanagawa, 150-0013, Japan

  • Shibasaki Internal Medicine and Pediatrics Clinic

    RECRUITING

    Sendai, Miyagi, 980-0871, Japan

  • Shinjo Terasu Clinic

    RECRUITING

    Kawasaki-shi, Kanagawa, 211-0044, Japan

  • Shizuka Medicine Clinic

    NOT_YET_RECRUITING

    Musashino, Tokyo, 370-0071, Japan

  • Sugiura Clinic

    RECRUITING

    Kawaguchi-shi, Saitama, 332-0012, Japan

  • Terada Clinic Respiratory Medicine and General Practice

    RECRUITING

    Himeji-shi, Hyôgo, 670-0849, Japan

  • Toda Internal Medicine & Neurology

    RECRUITING

    Akashi-Shi, Hyôgo, 674-0081, Japan

  • Tokyo Center Clinic

    RECRUITING

    Chuo-Ku, Tokyo, 103-0027, Japan

  • Tomita Internal Medicine Clinic

    RECRUITING

    Fukuoka, 810-0033, Japan

  • Tsuchiura Beryl Clinic

    RECRUITING

    Takasaki-shi, Gunma, 300-0062, Japan

  • Yotsuya Naika

    RECRUITING

    Shibuya-Ku, Tokyo, 160-0017, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.