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COVID-19Phase 3NCT05605093

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)

A Phase 3 study testing Shionogi Protease Inhibitor (S-217622) in people with COVID-19, run by University of Minnesota at 187 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Shionogi Protease Inhibitor (S-217622)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
602 participants
Where
187 sitesin 24 countries
Study dates
23 Dec 2022to 28 Oct 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

187 sites in 24 countries.

187 sites in 24 countries

United States103 sites

  • Hendrick Medical Center (Site 080-014)

    Abilene, Texas, 79601

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

    Albuquerque, New Mexico, 87106

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

    Ann Arbor, Michigan, 48105

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

    Aurora, Colorado, 80045

  • University of Colorado Hospital (Site 204-001)

    Aurora, Colorado, 80045

  • NIH Clinical Center (Site 080-043)

    Bethesda, Maryland, 20892

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

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital (202-002)

    Boston, Massachusetts, 02114

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

    Boston, Massachusetts, 02215

  • NYU Brooklyn (301-033)

    Brooklyn, New York, 11220

  • Cooper University Hospital (Site 019-001)

    Camden, New Jersey, 08103

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

    Charleston, South Carolina, 29401

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

    Charleston, South Carolina, 29425

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

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60612

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

    Chicago, Illinois, 60612

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

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation (Site 207-001)

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43210

  • CHRISTUS Spohn Shoreline Hospital (Site 080-001)

    Corpus Christi, Texas, 78405

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

    Dallas, Texas, 75246

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

    Dallas, Texas, 75390

  • UT Southwestern Medical Center (Site 084-001)

    Dallas, Texas, 75390

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

    Denver, Colorado, 80204

  • Henry Ford Health System (Site 014-001)

    Detroit, Michigan, 48202

  • Sinai-Grace Hospital (Site 205-005)

    Detroit, Michigan, 48235

  • Duke University Hospital (Site 301-006)

    Durham, North Carolina, 27710

  • New York Presbyterian Queens (003-005)

    Flushing, New York, 11355

  • Lutheran Medical Group (Site 301-010)

    Fort Wayne, Indiana, 46804

  • UCSF Fresno (Site 203-005)

    Fresno, California, 93721

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

    Gainesville, Florida, 32610

  • Hackensack Meridian Health (Site 301-030)

    Hackensack, New Jersey, 07601

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

    Hershey, Pennsylvania, 17033

  • Houston Methodist Hospital (Site 301-028)

    Houston, Texas, 77030

  • MEDVAMC (Site 074-006)

    Houston, Texas, 77030

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

    Houston, Texas, 77030

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

    Jackson, Mississippi, 39216

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

    Kansas City, Kansas, 66160

  • Dartmouth-Hitchcock Medical Center (301-024)

    Lebanon, New Hampshire, 03756

  • University of Kentucky (Site 210-004)

    Lexington, Kentucky, 40536

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

    Loma Linda, California, 92357

  • MemorialCare Health System (Site 066-003

    Long Beach, California, 90806

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

    Long Beach, California, 90822

  • Mount Sinai Queens (Site 081-105)

    Long Island City, New York, 11102

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

    Longview, Texas, 75601

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

    Los Angeles, California, 90048

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

    Los Angeles, California, 90095

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

    Madison, Wisconsin, 53705

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

    Mather, California, 95655

  • Miami VA Healthcare System (Site 074-003)

    Miami, Florida, 33125

  • Froedtert Memorial Lutheran Hospital (052-001)

    Milwaukee, Wisconsin, 53226

  • NYU Long Island (301-034)

    Mineola, New York, 11501

  • Hennepin Healthcare Research Institute (Site 027-001)

    Minneapolis, Minnesota, 55415

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

    Minneapolis, Minnesota, 55455

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • West Virginia University Medicine (301-023)

    Morgantown, West Virginia, 26506

  • Intermountain Medical Center (Site 211-001)

    Murray, Utah, 84107

  • Vanderbilt University Medical Center (Site 212-001)

    Nashville, Tennessee, 37212

  • Yale University (Site 025-001)

    New Haven, Connecticut, 06510

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

    New York, New York, 10016

  • Mount Sinai Medical Center (Site 301-012)

    New York, New York, 10029

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

    New York, New York, 10037

  • Weill Cornell Clinical Research Unit (065-001)

    New York, New York, 10065

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

    Newark, New Jersey, 07103

  • Hoag Memorial Hospital Presbyterian (Site 080-026)

    Newport Beach, California, 92663

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

    Omaha, Nebraska, 68198

  • Orlando VA Medical Center (Site 074-032)

    Orlando, Florida, 32827

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

    Palo Alto, California, 94304

  • Portland VA Health Care System (074-024)

    Portland, Oregon, 97239

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

    Potsdam, New York, 13676

  • Rhode Island Hospital (Site 080-036)

    Providence, Rhode Island, 02903

  • The Miriam Hospital (Site 080-039)

    Providence, Rhode Island, 02906

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

    Rapid City, South Dakota, 57701

  • Mayo Clinic (Site 054-001)

    Rochester, Minnesota, 55905

  • UC Davis Health (Site 203-004)

    Sacramento, California, 95817

  • Salem VA Medical Center (Site 074-014)

    Salem, Virginia, 24153

  • University of Utah Health (Site 211-002)

    Salt Lake City, Utah, 84108

  • UT Health San Antonio (Site 009-022)

    San Antonio, Texas, 78229

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

    San Diego, California, 92161

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

    San Francisco, California, 94110

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

    San Francisco, California, 94115

  • San Francisco VAMC (Site 074-002)

    San Francisco, California, 94121

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

    San Francisco, California, 94143

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

    Santa Fe, New Mexico, 87505

  • Harborview Medical Center (208-001)

    Seattle, Washington, 98104

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

    Spokane, Washington, 99204

  • Baystate Medical Center (Site 201-001)

    Springfield, Massachusetts, 01199

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

    St Louis, Missouri, 63110

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

    Stanford, California, 94305

  • Tampa General Hospital (032-001)

    Tampa, Florida, 33606

  • Lincoln Medical Center (Site 003-016)

    The Bronx, New York, 10451

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

    The Bronx, New York, 10467

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

    The Bronx, New York, 10467

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

    The Bronx, New York, 10468

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

    Torrance, California, 90502

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

    Tucson, Arizona, 85719

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

    Tucson, Arizona, 85723

  • Carle Foundation Hospital (Site 080-049)

    Urbana, Illinois, 61801

  • Kent County Memorial Hospital (080-048)

    Warwick, Rhode Island, 02886

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

    Washington D.C., District of Columbia, 20010

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

    Washington D.C., District of Columbia, 20422

  • Wake Forest Baptist Health (Site 210-001)

    Winston-Salem, North Carolina, 27157

  • UMass Chan Medical School (Site 080-007)

    Worcester, Massachusetts, 01655

Other trials in United States

Brazil12 sites

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

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

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

    Criciúma, Santa Catarina, 88801-000

  • Hospital Nereu Ramos (Site 649-210)

    Florianópolis, Santa Catarina, 88025-301

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

    Joinville, Santa Catarina, 89204-061

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

    Marília, São Paulo, 17525-160

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

    Porto Alegre, Rio Grande do Sul, 90410

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

    São Paulo, São Paulo, 01246-000

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

    São Paulo, São Paulo, 01323-001

  • Hospital Alemão Oswaldo Cruz (649-215)

    São Paulo, São Paulo, 01327-001

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

    São Paulo, São Paulo, 04004-030

  • Hospital SEPACO (649-207)

    São Paulo, São Paulo, 04102-900

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

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

Denmark10 sites

  • Aalborg Hospital (Site 625-005)

    Aalborg, 9000

  • Aarhus Universitetshospital, Skejby (625-002)

    Aarhus, N, 200

  • Rigshospitalet, CHIP (Site 625-006)

    Copenhagen, 2100

  • Bispebjerg Hospital (Site 625-013)

    Copenhagen, 2400

  • Herlev/Gentofte Hospital (Site 625-012)

    Hellerup, 2900

  • Nordsjaellands Hospital, Hillerod (Site 625-009)

    Hillerød, 3400

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

    Hvidovre, 2650

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

    Kolding, 6000

  • Odense University Hospital (Site 625-004)

    Odense, 5000

  • Zealand University Hospital Roskilde (Site 625-010)

    Roskilde, 4000

Other trials in Denmark

Argentina7 sites

  • CEMIC (Site 611-021)

    Buenos Aires, 1431

  • Sanatorio Allende (Site 611-030)

    Córdoba, Córdoba Province, X5000JHQ

  • Hospital Rawson (Site 611-012)

    Córdoba, 5000

  • Instituto Medico Platense (Site 611-025)

    La Plata, Buenos Aires, B1900AVG

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

    Rosario, Santa Fe Province, 2000

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

    Santa Fe, 3000

  • Clínica Central S.A. (611-028)

    Villa Regina, Río Negro Province, R8336

Other trials in Argentina

Spain7 sites

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

    Badalona, Barcelona, 08916

  • Hospital del Mar (626-025)

    Barcelona, 08003

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

    Barcelona, 08035

  • Hospital Clinic de Barcelona (626-004)

    Barcelona, 08036

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

    Madrid, 28017

  • Hospital Clínico San Carlos (Site 626-017)

    Madrid, 28040

  • Hospital Universitario La Paz (Site 626-012)

    Madrid, 28046

Other trials in Spain

Australia5 sites

  • Austin Health (612-020)

    Heidelberg, Victoria, 3084

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

    Liverpool, New South Wales, 2170

  • The Alfred Hospital (Site 612-017)

    Melbourne, Victoria, 3004

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

    Sydney, New South Wales, 2010

  • Westmead Hospital (Site 612-058)

    Westmead, New South Wales, 2145

Other trials in Australia

Greece5 sites

  • Democritus University of Thrace (635-021)

    Alexandroupoli, Evros, 68131

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

    Athens, Attica, 10676

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

    Athens, Attica, 11527

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

    Athens, Attica, 11527

  • Attikon University General Hospital (Site 635-009)

    Athens, Attica, 12462

Other trials in Greece

Uganda5 sites

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

    Entebbe

  • Gulu Regional Referral Hospital (634-603)

    Gulu

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

    Kampala

  • Lira Regional Referral Hospital (634-605)

    Lira

  • Masaka Regional Referral Hospital (634-606)

    Masaka

Other trials in Uganda

South Korea4 sites

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

    Seocho, Seoul, 06591

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

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center (612-901)

    Seoul, 05505

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

    Seoul, 06973

Other trials in South Korea

Germany3 sites

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

    Bonn, 53127

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

    Cologne, 50937

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

    Frankfurt, 60590

Other trials in Germany

Japan3 sites

  • Rinku General Medical Center (Site 612-107)

    Osaka, 598-8577

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

    Shinjuku-Ku, Tokyo, 162-8655

  • Fujita Health University Hospital (Site 612-105)

    Toyoake, Aichi-ken, 470-1192

Other trials in Japan

Mexico3 sites

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

    Mexico City, Mexico City, 14080

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

    Mexico City, Mexico City, 14080

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

    Oaxaca City, OA, 68050

Other trials in Mexico

South Africa3 sites

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

    Cape Town, Western Cape, 7925

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

    Durban, KwaZulu-Natal, 4013

  • Greys Hospital (080-202)

    Pietermaritzburg, KwaZulu-Natal, 3201

Other trials in South Africa

Ukraine3 sites

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

    Ivano-Frankivsk, 76018

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

    Kyiv, 02002

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

    Zhytomyr, 1002

Other trials in Ukraine

United Kingdom3 sites

  • Royal Free Hospital (634-006)

    London, NW3 2QG

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

    London, SE1 7EH

  • Royal Victoria Infirmary (Site 634-007)

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Peru2 sites

  • Hospital Nacional Hipolito Unanue (651-008)

    Lima, 15007

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

    Lima, 15324

Other trials in Peru

Thailand2 sites

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

    Bangkok, 10330

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

    Khon Kaen, 40002

Other trials in Thailand

Georgia1 site

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

    Tbilisi, 0159

Other trials in Georgia

Nigeria1 site

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

    Abuja, Federal Capital Territory

Other trials in Nigeria

Poland1 site

  • Wojewodzki Szpital Zakazny (Site 625-302)

    Warsaw, 01-201

Other trials in Poland

Puerto Rico1 site

  • VA Caribbean Health Care (074-033)

    San Juan, PR, 00921-3201

Other trials in Puerto Rico

Singapore1 site

  • Tan Tock Seng Hospital (Site 612-201)

    Singapore, 308433

Other trials in Singapore

Switzerland1 site

  • University Hospital Zurich (Site 621-201)

    Zurich, 8091

Other trials in Switzerland

Zimbabwe1 site

  • Parirenyatwa General Hospital (Site 634-901)

    Harare

Other trials in Zimbabwe

About this study

Official title: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd.

The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

Conditions
COVID-19
Being tested
Shionogi Protease Inhibitor (S-217622), placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shionogi Protease Inhibitor (S-217622)Drug

    Also called ensitrelvir

    S-217622 (ensitrelvir) is an oral anti-SARS-CoV2 PI that does not require ritonavir co-administration The dose is 375/125 (375 mg on Day 0, followed by 125 mg daily on Days 1-4).

  • placeboDrug

    Placebo is an oral tablet administered once (3 tabs) on Day 0 and once (1 tab) daily on days 1-4, 5-day course.

Study groups in NCT05605093
Study groupRoleWhat they receive
S-217622 (ensitrelvir) plus standard of care (SOC)ExperimentalStudy investigational agent (ensitrelvir) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.
Receives: Drug: Shionogi Protease Inhibitor (S-217622)
placebo plus standard of care (SOC)Placebo comparatorStudy investigational placebo will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Recovered by Day 60

    Number of participants who recovered by Day 60. Recovery was assessed through Day 60 using the Days to Recovery Scale.

    Measured: Through Day 60

Secondary outcomes (4)

  1. Mortality

    Percentage of participants who died through Day 60

    Measured: 60 days post-treatment

  2. A 3-category Ordinal Outcome

    A 3-category outcome that represents the participant's status on Day 60. The 3 categories are 1. Recovered on Day 60, 2. Alive, not recovered on Day 60, 3. Died by Day 60"

    Measured: 60 days post-treatment

  3. Recovery

    Number of participants that recovered, defined as returning to place of residence prior to the onset of COVD-19 illness for 14 consecutive days

    Measured: 60 days post-treatment

  4. Percentage of Participants Who Died or Required New Invasive Mechanical Ventilation

    Measured: Through Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start23 Dec 2022
  3. Primary completion28 Oct 2025
  4. Study completion28 Oct 2025

Why it stopped: DSMB closed due to futility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605093
Sponsor's protocol ID
S-217622
Status last verified
Aug 2026
First submitted
28 Oct 2022
Last updated
24 Sep 2026
FDA-regulated drug
Yes
FDA-regulated device
No

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