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COVID pill trial halted early: what happened?

NCT ID NCT05605093

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral antiviral drug called ensitrelvir in hospitalized COVID-19 patients. The goal was to see if it could help them recover faster. However, the trial was stopped early, so we have limited information on whether it works.

What this could mean

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

Active substance
ensitrelvir (S-217622)
What this could lead to
If successful, this could provide an additional oral treatment option for hospitalized COVID-19 patients to speed recovery.
What could go wrong
The trial was terminated early, so we don't have clear evidence it works. It was also tested alongside other treatments, making it hard to know its specific effect.

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

602 people

The number who actually took part.

Started

Dec 2022

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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.

Inclusion Criteria: * Age ≥18 years. * Informed consent for trial participation. * Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection. * Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test \[list of approved tests is in the PIM\] collected within the prior 14 days. * Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization. * Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection. Exclusion Criteria: * The patient is expected to be discharged from the hospital within the next 24 hours. * Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. * Use of a strong CYP3A inducer within 14 days prior to enrollment * Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. * Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life. * Expected inability or unwillingness to participate in study procedures. * In the opinion of the investigator, participation in a trial is not in the best interest of the patient. * Allergy to investigational agent or vehicle * Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 * Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure. * Known estimated glomerular filtration rate (eGRF) \<30 mL/min/1.73m 2 * Continuous renal replacement therapy or chronic dialysis * Current pregnancy * Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent. * Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent. * Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent. * Inability to take investigational agent in tablet form by mouth.

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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.

COVID -19

Contacts and locations

Locations

  • 1st Respiratory Medicine Dept, Athens University Medical School (635-015)

    Athens, Attica, 11527, Greece

  • 3rd Dept of Medicine, Medical School (635-022)

    Athens, Attica, 11527, Greece

  • AIDS and Clinical Immunology Research Center (Site 627-201)

    Tbilisi, 0159, Georgia

  • Aalborg Hospital (Site 625-005)

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital, Skejby (625-002)

    Aarhus, N, 200, Denmark

  • Asan Medical Center (612-901)

    Seoul, 05505, South Korea

  • Associação Beneficente Hospital Universitário - Universidade de Marília (Site 649-212)

    Marília, São Paulo, 17525-160, Brazil

  • Associação Beneficente Síria - HCor (Site 649-203)

    São Paulo, São Paulo, 04004-030, Brazil

  • Attikon University General Hospital (Site 635-009)

    Athens, Attica, 12462, Greece

  • Austin Health (612-020)

    Heidelberg, Victoria, 3084, Australia

  • Banner University Medical Center Tucson (Site 206-004)

    Tucson, Arizona, 85719, United States

  • Baylor, Scott and White Health (301-003)

    Dallas, Texas, 75246, United States

  • Baystate Medical Center (Site 201-001)

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center (Site 202-001)

    Boston, Massachusetts, 02215, United States

  • Bispebjerg Hospital (Site 625-013)

    Copenhagen, 2400, Denmark

  • CEMIC (Site 611-021)

    Buenos Aires, 1431, Argentina

  • CHRISTUS - St. Vincent (Site 080-051)

    Santa Fe, New Mexico, 87505, United States

  • CHRISTUS Good Shepherd Medical Center (Site 080-031)

    Longview, Texas, 75601, United States

  • CHRISTUS Spohn Shoreline Hospital (Site 080-001)

    Corpus Christi, Texas, 78405, United States

  • Carle Foundation Hospital (Site 080-049)

    Urbana, Illinois, 61801, United States

  • Cedars-Sinai Medical Center (Site 208-002)

    Los Angeles, California, 90048, United States

  • Center Hospital of the National Center for Global Health and Medicine (Site 612-101)

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302)

    Ivano-Frankivsk, 76018, Ukraine

  • Chulalongkorn University and The HIV-NAT (Site 613-001)

    Bangkok, 10330, Thailand

  • Chung-Ang University Hospital (Site 612-902)

    Seoul, 06973, South Korea

  • Cleveland Clinic Foundation (Site 207-001)

    Cleveland, Ohio, 44195, United States

  • Clínica Central S.A. (611-028)

    Villa Regina, Río Negro Province, R8336, Argentina

  • Cooper University Hospital (Site 019-001)

    Camden, New Jersey, 08103, United States

  • Dartmouth-Hitchcock Medical Center (301-024)

    Lebanon, New Hampshire, 03756, United States

  • Democritus University of Thrace (635-021)

    Alexandroupoli, Evros, 68131, Greece

  • Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital (635-020)

    Athens, Attica, 10676, Greece

  • Duke University Hospital (Site 301-006)

    Durham, North Carolina, 27710, United States

  • Durban International Clinical Research Site (WWH) (652-005)

    Durban, KwaZulu-Natal, 4013, South Africa

  • Froedtert Memorial Lutheran Hospital (052-001)

    Milwaukee, Wisconsin, 53226, United States

  • Fujita Health University Hospital (Site 612-105)

    Toyoake, Aichi-ken, 470-1192, Japan

  • Fundação Universidade Caxias do Sul Hospital Geral (649-218)

    Caxias do Sul, Rio Grande do Sul, 95070-561, Brazil

  • Greys Hospital (080-202)

    Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

  • Gulu Regional Referral Hospital (634-603)

    Gulu, Uganda

  • Guy's & St. Thomas' NHS Foundation Trust (Site 634-011)

    London, SE1 7EH, United Kingdom

  • Hackensack Meridian Health (Site 301-030)

    Hackensack, New Jersey, 07601, United States

  • Harborview Medical Center (208-001)

    Seattle, Washington, 98104, United States

  • Hendrick Medical Center (Site 080-014)

    Abilene, Texas, 79601, United States

  • Hennepin Healthcare Research Institute (Site 027-001)

    Minneapolis, Minnesota, 55415, United States

  • Henry Ford Health System (Site 014-001)

    Detroit, Michigan, 48202, United States

  • Herlev/Gentofte Hospital (Site 625-012)

    Hellerup, 2900, Denmark

  • Hoag Memorial Hospital Presbyterian (Site 080-026)

    Newport Beach, California, 92663, United States

  • Hospital #1 of Zhytomyr City Council (627-303)

    Zhytomyr, 1002, Ukraine

  • Hospital Alemão Oswaldo Cruz (649-215)

    São Paulo, São Paulo, 01327-001, Brazil

  • Hospital Clinic de Barcelona (626-004)

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos (Site 626-017)

    Madrid, 28040, Spain

  • Hospital General Dr. Aurelio Valdivieso (Site 653-004)

    Oaxaca City, OA, 68050, Mexico

  • Hospital General Universitario Gregorio Marañón (Site 626-001)

    Madrid, 28017, Spain

  • Hospital Nacional Hipolito Unanue (651-008)

    Lima, 15007, Peru

  • Hospital Nacional Sergio E. Bernales (651-007)

    Lima, 15324, Peru

  • Hospital Nereu Ramos (Site 649-210)

    Florianópolis, Santa Catarina, 88025-301, Brazil

  • Hospital Rawson (Site 611-012)

    Córdoba, 5000, Argentina

  • Hospital SEPACO (649-207)

    São Paulo, São Paulo, 04102-900, Brazil

  • Hospital Universitari Germans Trias i Pujol (626-003)

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron (Site 626-033)

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz (Site 626-012)

    Madrid, 28046, Spain

  • Hospital de Clínicas de Porto Alegre (649-101)

    Porto Alegre, Rio Grande do Sul, 90410, Brazil

  • Hospital del Mar (626-025)

    Barcelona, 08003, Spain

  • Houston Methodist Hospital (Site 301-028)

    Houston, Texas, 77030, United States

  • Hvidovre University Hospital, Department of Infections Diseases (Site 625-001)

    Hvidovre, 2650, Denmark

  • Institute of Human Virology-Nigeria (IHVN) (Site 612-601)

    Abuja, Federal Capital Territory, Nigeria

  • Instituto Medico Platense (Site 611-025)

    La Plata, Buenos Aires, B1900AVG, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Site 653-001)

    Mexico City, Mexico City, 14080, Mexico

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas (Site 653-002)

    Mexico City, Mexico City, 14080, Mexico

  • Instituto de Infectologia Emílio Ribas - IIER (Site 649-001)

    São Paulo, São Paulo, 01246-000, Brazil

  • Intermountain Medical Center (Site 211-001)

    Murray, Utah, 84107, United States

  • James J. Peters VAMC (Site 023-003)

    The Bronx, New York, 10468, United States

  • Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS (622-001)

    Frankfurt, 60590, Germany

  • John H. Stroger, Jr. Hospital of Cook County (Site 080-046)

    Chicago, Illinois, 60612, United States

  • Kent County Memorial Hospital (080-048)

    Warwick, Rhode Island, 02886, United States

  • Khon Kaen University, Srinagarind Hospital (Site 613-003)

    Khon Kaen, 40002, Thailand

  • Klinik I für Innere Medizin der Universität zu Köln (Site 622-008)

    Cologne, 50937, Germany

  • Kolding Sygehus, Medicinsk Afdeling (Site 625-011)

    Kolding, 6000, Denmark

  • Lincoln Medical Center (Site 003-016)

    The Bronx, New York, 10451, United States

  • Lira Regional Referral Hospital (634-605)

    Lira, Uganda

  • Lundquist Institute for Biomedical Innovation (Site 066-002)

    Torrance, California, 90502, United States

  • Lutheran Medical Group (Site 301-010)

    Fort Wayne, Indiana, 46804, United States

  • M Health Fairview University of Minnesota Medical Center (Site 112-001)

    Minneapolis, Minnesota, 55455, United States

  • MEDVAMC (Site 074-006)

    Houston, Texas, 77030, United States

  • MRC/UVRI & LSHTM Uganda Research Unit (634-601)

    Entebbe, Uganda

  • Masaka Regional Referral Hospital (634-606)

    Masaka, Uganda

  • Massachusetts General Hospital (202-002)

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic (Site 054-001)

    Rochester, Minnesota, 55905, United States

  • MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina (Site 210-002)

    Charleston, South Carolina, 29425, United States

  • MemorialCare Health System (Site 066-003

    Long Beach, California, 90806, United States

  • Miami VA Healthcare System (Site 074-003)

    Miami, Florida, 33125, United States

  • Montefiore Medical Center - Moses Hospital (Site 206-001)

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center - Weiler campus (Site 206-003)

    The Bronx, New York, 10467, United States

  • Monument Health Rapid City Hospital (Site 213-005)

    Rapid City, South Dakota, 57701, United States

  • Mount Sinai Medical Center (Site 301-012)

    New York, New York, 10029, United States

  • Mount Sinai Queens (Site 081-105)

    Long Island City, New York, 11102, United States

  • NIH Clinical Center (Site 080-043)

    Bethesda, Maryland, 20892, United States

  • NYC Health + Hospital Harlem (Site 003-003)

    New York, New York, 10037, United States

  • NYU Brooklyn (301-033)

    Brooklyn, New York, 11220, United States

  • NYU Long Island (301-034)

    Mineola, New York, 11501, United States

  • New Jersey Medical School Clinical Research Center (028-001)

    Newark, New Jersey, 07103, United States

  • New York Presbyterian Queens (003-005)

    Flushing, New York, 11355, United States

  • New York University Tisch Hospital (Site 301-013)

    New York, New York, 10016, United States

  • Nordsjaellands Hospital, Hillerod (Site 625-009)

    Hillerød, 3400, Denmark

  • Odense University Hospital (Site 625-004)

    Odense, 5000, Denmark

  • Ohio State University Wexner Medical Center (Site 207-004)

    Columbus, Ohio, 43210, United States

  • Orlando VA Medical Center (Site 074-032)

    Orlando, Florida, 32827, United States

  • Parirenyatwa General Hospital (Site 634-901)

    Harare, Zimbabwe

  • Parkland Health and Hospital Systems (Site 084-002)

    Dallas, Texas, 75390, United States

  • Penn State Health Milton S. Hershey Medical Center (Site 209-002)

    Hershey, Pennsylvania, 17033, United States

  • Portland VA Health Care System (074-024)

    Portland, Oregon, 97239, United States

  • Providence (Sacred Heart) (Site 213-004)

    Spokane, Washington, 99204, United States

  • Public Health Institute at Denver Health (Site 017-004)

    Denver, Colorado, 80204, United States

  • Ralph H. Johnson VA Medical Center (Site 074-015)

    Charleston, South Carolina, 29401, United States

  • Real e Benemérita Associação Portuguesa de Beneficência de São Paulo (Site 649-201

    São Paulo, São Paulo, 01323-001, Brazil

  • Rhode Island Hospital (Site 080-036)

    Providence, Rhode Island, 02903, United States

  • Rigshospitalet, CHIP (Site 625-006)

    Copenhagen, 2100, Denmark

  • Rinku General Medical Center (Site 612-107)

    Osaka, 598-8577, Japan

  • Rocky Mountain Regional VA Medical Center (Site 074-010)

    Aurora, Colorado, 80045, United States

  • Ronald Reagan UCLA Medical Center (Site 203-002)

    Los Angeles, California, 90095, United States

  • Royal Free Hospital (634-006)

    London, NW3 2QG, United Kingdom

  • Royal Victoria Infirmary (Site 634-007)

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Salem VA Medical Center (Site 074-014)

    Salem, Virginia, 24153, United States

  • San Francisco VAMC (Site 074-002)

    San Francisco, California, 94121, United States

  • Sanatorio Allende (Site 611-030)

    Córdoba, Córdoba Province, X5000JHQ, Argentina

  • Sanatorio Británico S.A. (611-027)

    Rosario, Santa Fe Province, 2000, Argentina

  • Sanatorio Medico de Diagnostico y Tratamiento (611-029)

    Santa Fe, 3000, Argentina

  • Seoul National University Bundang Hospital (Site 612-904)

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul St. Mary's Hospital (Site 612-903)

    Seocho, Seoul, 06591, South Korea

  • Sinai-Grace Hospital (Site 205-005)

    Detroit, Michigan, 48235, United States

  • Sociedade Beneficente de Senhoras Hospital Sirio-Libanês (Site 649-217)

    São Paulo, São Paulo, 05652-900, Brazil

  • Sociedade Literária e Caritativa Santo Agostinho - Hospital São José (Site 649-204)

    Criciúma, Santa Catarina, 88801-000, Brazil

  • South Western Sydney Local Health District, Liverpool (Site 612-063)

    Liverpool, New South Wales, 2170, Australia

  • Southern Arizona VA Healthcare System (Site 074-009)

    Tucson, Arizona, 85723, United States

  • St. Francis Hospital, Nsambya (Site 634-607)

    Kampala, Uganda

  • St. Lawrence Health System (Site 301-029)

    Potsdam, New York, 13676, United States

  • St. Vincent's Hospital (Site 612-002)

    Sydney, New South Wales, 2010, Australia

  • Stanford University Hospital & Clinics (Site 203-003)

    Stanford, California, 94305, United States

  • Tampa General Hospital (032-001)

    Tampa, Florida, 33606, United States

  • Tan Tock Seng Hospital (Site 612-201)

    Singapore, 308433, Singapore

  • The Alfred Hospital (Site 612-017)

    Melbourne, Victoria, 3004, Australia

  • The Miriam Hospital (Site 080-039)

    Providence, Rhode Island, 02906, United States

  • The University of Kansas Hospital (Site 080-044)

    Kansas City, Kansas, 66160, United States

  • Treatment and Diagnostic Center ADONIS Plus (627-304)

    Kyiv, 02002, Ukraine

  • UC Davis Health (Site 203-004)

    Sacramento, California, 95817, United States

  • UCSF Fresno (Site 203-005)

    Fresno, California, 93721, United States

  • UCSF Medical Center at Mount Zion (203-007)

    San Francisco, California, 94115, United States

  • UMass Chan Medical School (Site 080-007)

    Worcester, Massachusetts, 01655, United States

  • UT Health San Antonio (Site 009-022)

    San Antonio, Texas, 78229, United States

  • UT Southwestern Medical Center (Site 084-001)

    Dallas, Texas, 75390, United States

  • Unimed Joinville Cooperativa de Trabalho Médico (Site 649-202)

    Joinville, Santa Catarina, 89204-061, Brazil

  • University Hospital Zurich (Site 621-201)

    Zurich, 8091, Switzerland

  • University of Alabama Birmingham University Hospital (Site 213-002)

    Birmingham, Alabama, 35233, United States

  • University of California San Francisco (Site 203-001)

    San Francisco, California, 94143, United States

  • University of Cape Town (UCT) Lung Institute (Site 080-201)

    Cape Town, Western Cape, 7925, South Africa

  • University of Cincinnati Medical Center (Site 207-003)

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Hospital (Site 204-001)

    Aurora, Colorado, 80045, United States

  • University of Florida - Gainesville (Site 201-004)

    Gainesville, Florida, 32610, United States

  • University of Illinois at Chicago (Site 008-012)

    Chicago, Illinois, 60612, United States

  • University of Kentucky (Site 210-004)

    Lexington, Kentucky, 40536, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center (Site 202-005)

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center (Site 080-045)

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Hospital (Site 213-008)

    Albuquerque, New Mexico, 87106, United States

  • University of Texas Health Science Center (Site 203-006)

    Houston, Texas, 77030, United States

  • University of Utah Health (Site 211-002)

    Salt Lake City, Utah, 84108, United States

  • University of Virginia Health System, University Hospital (Site 210-003)

    Charlottesville, Virginia, 22908, United States

  • Universitätsklinikum Bonn, Medizinische Klinik I, Immunologische Ambulanz (622-010)

    Bonn, 53127, Germany

  • VA Ann Arbor Healthcare System (Site 074-028)

    Ann Arbor, Michigan, 48105, United States

  • VA Caribbean Health Care (074-033)

    San Juan, PR, 00921-3201, Puerto Rico

  • VA Loma Linda Healthcare System (Site 074-017)

    Loma Linda, California, 92357, United States

  • VA Long Beach Healthcare System (Site 074-026)

    Long Beach, California, 90822, United States

  • VA Northern California Health Care System (Site 074-023)

    Mather, California, 95655, United States

  • VA San Diego Healthcare System (Site 074-016)

    San Diego, California, 92161, United States

  • Vanderbilt University Medical Center (Site 212-001)

    Nashville, Tennessee, 37212, United States

  • Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)

    Palo Alto, California, 94304, United States

  • Wake Forest Baptist Health (Site 210-001)

    Winston-Salem, North Carolina, 27157, United States

  • Washington DC VA Medical Center (Site 009-004)

    Washington D.C., District of Columbia, 20422, United States

  • Washington University School of Medicine (Site 003-001)

    St Louis, Missouri, 63110, United States

  • Weill Cornell Clinical Research Unit (065-001)

    New York, New York, 10065, United States

  • West Virginia University Medicine (301-023)

    Morgantown, West Virginia, 26506, United States

  • Westmead Hospital (Site 612-058)

    Westmead, New South Wales, 2145, Australia

  • William S. Middleton Memorial Veterans Hospital (074-030)

    Madison, Wisconsin, 53705, United States

  • Wojewodzki Szpital Zakazny (Site 625-302)

    Warsaw, 01-201, Poland

  • Yale University (Site 025-001)

    New Haven, Connecticut, 06510, United States

  • Zealand University Hospital Roskilde (Site 625-010)

    Roskilde, 4000, Denmark

  • Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)

    San Francisco, California, 94110, United States

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