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

NCT05605093 | Terminated Phase 3 FDA Drug

• 1 other identifier: S-217622
• Study Type: interventional
• Target: 602
• Locations: 24 countries
• Sites: 187

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Days to Recovery Scale assessed over 60 days (DRS-60)

  DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62.

  60 days post-intervention

Secondary Outcomes (4)

• mortality

  60 days post-treatment

• a 3-category ordinal outcome

  60 days post-treatment

• time to recovery

  60 days post-treatment

• proportion of participants who died or required new invasive mechanical ventilation

  60 days post-treatment

Study Arms (2)

S-217622 (ensitrelvir) plus standard of care (SOC)

EXPERIMENTAL

Study 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.

Drug: Shionogi Protease Inhibitor (S-217622)

placebo plus standard of care (SOC)

PLACEBO COMPARATOR

Study 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.

Drug: placebo

Interventions

Shionogi Protease Inhibitor (S-217622) DRUG

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).

Also known as: ensitrelvir

S-217622 (ensitrelvir) plus standard of care (SOC)

placebo DRUG

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

placebo plus standard of care (SOC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (187)

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

Birmingham, Alabama, 35233, United States

Location

Banner University Medical Center Tucson (Site 206-004)

Tucson, Arizona, 85719, United States

Location

Southern Arizona VA Healthcare System (Site 074-009)

Tucson, Arizona, 85723, United States

Location

UCSF Fresno (Site 203-005)

Fresno, California, 93721, United States

Location

VA Loma Linda Healthcare System (Site 074-017)

Loma Linda, California, 92357, United States

Location

MemorialCare Health System (Site 066-003

Long Beach, California, 90806, United States

Location

VA Long Beach Healthcare System (Site 074-026)

Long Beach, California, 90822, United States

Location

Cedars-Sinai Medical Center (Site 208-002)

Los Angeles, California, 90048, United States

Location

Ronald Reagan UCLA Medical Center (Site 203-002)

Los Angeles, California, 90095, United States

Location

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

Mather, California, 95655, United States

Location

Hoag Memorial Hospital Presbyterian (Site 080-026)

Newport Beach, California, 92663, United States

Location

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

Palo Alto, California, 94304, United States

Location

UC Davis Health (Site 203-004)

Sacramento, California, 95817, United States

Location

VA San Diego Healthcare System (Site 074-016)

San Diego, California, 92161, United States

Location

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

San Francisco, California, 94110, United States

Location

UCSF Medical Center at Mount Zion (203-007)

San Francisco, California, 94115, United States

Location

San Francisco VAMC (Site 074-002)

San Francisco, California, 94121, United States

Location

University of California San Francisco (Site 203-001)

San Francisco, California, 94143, United States

Location

Stanford University Hospital & Clinics (Site 203-003)

Stanford, California, 94305, United States

Location

Lundquist Institute for Biomedical Innovation (Site 066-002)

Torrance, California, 90502, United States

Location

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

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital (Site 204-001)

Aurora, Colorado, 80045, United States

Location

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

Denver, Colorado, 80204, United States

Location

Yale University (Site 025-001)

New Haven, Connecticut, 06510, United States

Location

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

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

Location

Washington DC VA Medical Center (Site 009-004)

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

Location

University of Florida - Gainesville (Site 201-004)

Gainesville, Florida, 32610, United States

Location

Miami VA Healthcare System (Site 074-003)

Miami, Florida, 33125, United States

Location

Orlando VA Medical Center (Site 074-032)

Orlando, Florida, 32827, United States

Location

Tampa General Hospital (032-001)

Tampa, Florida, 33606, United States

Location

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

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago (Site 008-012)

Chicago, Illinois, 60612, United States

Location

Carle Foundation Hospital (Site 080-049)

Urbana, Illinois, 61801, United States

Location

Lutheran Medical Group (Site 301-010)

Fort Wayne, Indiana, 46804, United States

Location

The University of Kansas Hospital (Site 080-044)

Kansas City, Kansas, 66160, United States

Location

University of Kentucky (Site 210-004)

Lexington, Kentucky, 40536, United States

Location

NIH Clinical Center (Site 080-043)

Bethesda, Maryland, 20892, United States

Location

Massachusetts General Hospital (202-002)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center (Site 202-001)

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center (Site 201-001)

Springfield, Massachusetts, 01199, United States

Location

UMass Chan Medical School (Site 080-007)

Worcester, Massachusetts, 01655, United States

Location

VA Ann Arbor Healthcare System (Site 074-028)

Ann Arbor, Michigan, 48105, United States

Location

Henry Ford Health System (Site 014-001)

Detroit, Michigan, 48202, United States

Location

Sinai-Grace Hospital (Site 205-005)

Detroit, Michigan, 48235, United States

Location

Hennepin Healthcare Research Institute (Site 027-001)

Minneapolis, Minnesota, 55415, United States

Location

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

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic (Site 054-001)

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center (Site 202-005)

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine (Site 003-001)

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Center (301-024)

Lebanon, New Hampshire, 03756, United States

Location

Cooper University Hospital (Site 019-001)

Camden, New Jersey, 08103, United States

Location

Hackensack Meridian Health (Site 301-030)

Hackensack, New Jersey, 07601, United States

Location

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

Newark, New Jersey, 07103, United States

Location

University of New Mexico Hospital (Site 213-008)

Albuquerque, New Mexico, 87106, United States

Location

CHRISTUS - St. Vincent (Site 080-051)

Santa Fe, New Mexico, 87505, United States

Location

NYU Brooklyn (301-033)

Brooklyn, New York, 11220, United States

Location

New York Presbyterian Queens (003-005)

Flushing, New York, 11355, United States

Location

Mount Sinai Queens (Site 081-105)

Long Island City, New York, 11102, United States

Location

NYU Long Island (301-034)

Mineola, New York, 11501, United States

Location

New York University Tisch Hospital (Site 301-013)

New York, New York, 10016, United States

Location

Mount Sinai Medical Center (Site 301-012)

New York, New York, 10029, United States

Location

NYC Health + Hospital Harlem (Site 003-003)

New York, New York, 10037, United States

Location

Weill Cornell Clinical Research Unit (065-001)

New York, New York, 10065, United States

Location

St. Lawrence Health System (Site 301-029)

Potsdam, New York, 13676, United States

Location

Lincoln Medical Center (Site 003-016)

The Bronx, New York, 10451, United States

Location

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

The Bronx, New York, 10467, United States

Location

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

The Bronx, New York, 10467, United States

Location

James J. Peters VAMC (Site 023-003)

The Bronx, New York, 10468, United States

Location

Duke University Hospital (Site 301-006)

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health (Site 210-001)

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Medical Center (Site 207-003)

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, 44195, United States

Location

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

Columbus, Ohio, 43210, United States

Location

Portland VA Health Care System (074-024)

Portland, Oregon, 97239, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital (Site 080-036)

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital (Site 080-039)

Providence, Rhode Island, 02906, United States

Location

Kent County Memorial Hospital (080-048)

Warwick, Rhode Island, 02886, United States

Location

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

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina (Site 210-002)

Charleston, South Carolina, 29425, United States

Location

Monument Health Rapid City Hospital (Site 213-005)

Rapid City, South Dakota, 57701, United States

Location

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee, 37212, United States

Location

Hendrick Medical Center (Site 080-014)

Abilene, Texas, 79601, United States

Location

CHRISTUS Spohn Shoreline Hospital (Site 080-001)

Corpus Christi, Texas, 78405, United States

Location

Baylor, Scott and White Health (301-003)

Dallas, Texas, 75246, United States

Location

Parkland Health and Hospital Systems (Site 084-002)

Dallas, Texas, 75390, United States

Location

UT Southwestern Medical Center (Site 084-001)

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital (Site 301-028)

Houston, Texas, 77030, United States

Location

MEDVAMC (Site 074-006)

Houston, Texas, 77030, United States

Location

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

Houston, Texas, 77030, United States

Location

CHRISTUS Good Shepherd Medical Center (Site 080-031)

Longview, Texas, 75601, United States

Location

UT Health San Antonio (Site 009-022)

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center (Site 211-001)

Murray, Utah, 84107, United States

Location

University of Utah Health (Site 211-002)

Salt Lake City, Utah, 84108, United States

Location

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

Charlottesville, Virginia, 22908, United States

Location

Salem VA Medical Center (Site 074-014)

Salem, Virginia, 24153, United States

Location

Harborview Medical Center (208-001)

Seattle, Washington, 98104, United States

Location

Providence (Sacred Heart) (Site 213-004)

Spokane, Washington, 99204, United States

Location

West Virginia University Medicine (301-023)

Morgantown, West Virginia, 26506, United States

Location

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

Madison, Wisconsin, 53705, United States

Location

Froedtert Memorial Lutheran Hospital (052-001)

Milwaukee, Wisconsin, 53226, United States

Location

Instituto Medico Platense (Site 611-025)

La Plata, Buenos Aires, B1900AVG, Argentina

Location

Sanatorio Allende (Site 611-030)

Córdoba, Córdoba Province, X5000JHQ, Argentina

Location

Clínica Central S.A. (611-028)

Villa Regina, Río Negro Province, R8336, Argentina

Location

Sanatorio Británico S.A. (611-027)

Rosario, Santa Fe Province, 2000, Argentina

Location

CEMIC (Site 611-021)

Buenos Aires, 1431, Argentina

Location

Hospital Rawson (Site 611-012)

Córdoba, 5000, Argentina

Location

Sanatorio Medico de Diagnostico y Tratamiento (611-029)

Santa Fe, 3000, Argentina

Location

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

Liverpool, New South Wales, 2170, Australia

Location

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

Sydney, New South Wales, 2010, Australia

Location

Westmead Hospital (Site 612-058)

Westmead, New South Wales, 2145, Australia

Location

Austin Health (612-020)

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital (Site 612-017)

Melbourne, Victoria, 3004, Australia

Location

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

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

Location

Hospital de Clínicas de Porto Alegre (649-101)

Porto Alegre, Rio Grande do Sul, 90410, Brazil

Location

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

Criciúma, Santa Catarina, 88801-000, Brazil

Location

Hospital Nereu Ramos (Site 649-210)

Florianópolis, Santa Catarina, 88025-301, Brazil

Location

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

Joinville, Santa Catarina, 89204-061, Brazil

Location

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

Marília, São Paulo, 17525-160, Brazil

Location

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

São Paulo, São Paulo, 01246-000, Brazil

Location

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

São Paulo, São Paulo, 01323-001, Brazil

Location

Hospital Alemão Oswaldo Cruz (649-215)

São Paulo, São Paulo, 01327-001, Brazil

Location

Associação Beneficente Síria - HCor (Site 649-203)

São Paulo, São Paulo, 04004-030, Brazil

Location

Hospital SEPACO (649-207)

São Paulo, São Paulo, 04102-900, Brazil

Location

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

São Paulo, São Paulo, 05652-900, Brazil

Location

Aarhus Universitetshospital, Skejby (625-002)

Aarhus, N, 200, Denmark

Location

Aalborg Hospital (Site 625-005)

Aalborg, 9000, Denmark

Location

Rigshospitalet, CHIP (Site 625-006)

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital (Site 625-013)

Copenhagen, 2400, Denmark

Location

Herlev/Gentofte Hospital (Site 625-012)

Hellerup, 2900, Denmark

Location

Nordsjaellands Hospital, Hillerod (Site 625-009)

Hillerød, 3400, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

Kolding Sygehus, Medicinsk Afdeling (Site 625-011)

Kolding, 6000, Denmark

Location

Odense University Hospital (Site 625-004)

Odense, 5000, Denmark

Location

Zealand University Hospital Roskilde (Site 625-010)

Roskilde, 4000, Denmark

Location

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

Tbilisi, 0159, Georgia

Location

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

Bonn, 53127, Germany

Location

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

Cologne, 50937, Germany

Location

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

Frankfurt, 60590, Germany

Location

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

Athens, Attica, 10676, Greece

Location

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

Athens, Attica, 11527, Greece

Location

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

Athens, Attica, 11527, Greece

Location

Attikon University General Hospital (Site 635-009)

Athens, Attica, 12462, Greece

Location

Democritus University of Thrace (635-021)

Alexandroupoli, Evros, 68131, Greece

Location

Fujita Health University Hospital (Site 612-105)

Toyoake, Aichi-ken, 470-1192, Japan

Location

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

Shinjuku-Ku, Tokyo, 162-8655, Japan

Location

Rinku General Medical Center (Site 612-107)

Osaka, 598-8577, Japan

Location

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

Mexico City, Mexico City, 14080, Mexico

Location

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

Mexico City, Mexico City, 14080, Mexico

Location

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

Oaxaca City, OA, 68050, Mexico

Location

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

Abuja, Federal Capital Territory, Nigeria

Location

Hospital Nacional Hipolito Unanue (651-008)

Lima, 15007, Peru

Location

Hospital Nacional Sergio E. Bernales (651-007)

Lima, 15324, Peru

Location

Wojewodzki Szpital Zakazny (Site 625-302)

Warsaw, 01-201, Poland

Location

VA Caribbean Health Care (074-033)

San Juan, PR, 00921-3201, Puerto Rico

Location

Tan Tock Seng Hospital (Site 612-201)

Singapore, 308433, Singapore

Location

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

Durban, KwaZulu-Natal, 4013, South Africa

Location

Greys Hospital (080-202)

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

Location

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

Cape Town, Western Cape, 7925, South Africa

Location

Seoul National University Bundang Hospital (Site 612-904)

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

Location

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

Seocho, Seoul, 06591, South Korea

Location

Asan Medical Center (612-901)

Seoul, 05505, South Korea

Location

Chung-Ang University Hospital (Site 612-902)

Seoul, 06973, South Korea

Location

Hospital Universitari Germans Trias i Pujol (626-003)

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar (626-025)

Barcelona, 08003, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona (626-004)

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañón (Site 626-001)

Madrid, 28017, Spain

Location

Hospital Clínico San Carlos (Site 626-017)

Madrid, 28040, Spain

Location

Hospital Universitario La Paz (Site 626-012)

Madrid, 28046, Spain

Location

University Hospital Zurich (Site 621-201)

Zurich, 8091, Switzerland

Location

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

Bangkok, 10330, Thailand

Location

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

Khon Kaen, 40002, Thailand

Location

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

Entebbe, Uganda

Location

Gulu Regional Referral Hospital (634-603)

Gulu, Uganda

Location

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

Kampala, Uganda

Location

Lira Regional Referral Hospital (634-605)

Lira, Uganda

Location

Masaka Regional Referral Hospital (634-606)

Masaka, Uganda

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

Treatment and Diagnostic Center ADONIS Plus (627-304)

Kyiv, 02002, Ukraine

Location

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

Zhytomyr, 1002, Ukraine

Location

Royal Free Hospital (634-006)

London, NW3 2QG, United Kingdom

Location

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

London, SE1 7EH, United Kingdom

Location

Royal Victoria Infirmary (Site 634-007)

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Parirenyatwa General Hospital (Site 634-901)

Harare, Zimbabwe

Location

MeSH Terms

Conditions

COVID-19

Interventions

ensitrelvir

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

• Cavan Reilly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Jason Baker, MD

  University of Minnesota

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 4, 2022
• Study Start: December 23, 2022
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

UG (5); DE (3); SG (1); ZI (1); JP (3); ES (7); CH (1); UA (3); KR (4); AU (5); AR (7); US (103); GB (3); ME (3); NG (1); DK (10); PE (2); PR (1); TH (2); GR (5); ZA (3); GE (1); PL (1); BR (12)