Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Launched by UNIVERSITY OF MINNESOTA · Oct 28, 2022
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The STRIVE clinical trial is studying a new treatment called ensitrelvir for patients hospitalized with COVID-19. This treatment aims to help improve recovery by targeting the virus that causes COVID-19, especially for those experiencing respiratory infections. The trial will compare ensitrelvir with a placebo (a non-active treatment) while patients continue to receive standard care, which may include other antiviral medications and therapy to support their immune system.
To participate in this trial, you need to be at least 18 years old, have a confirmed COVID-19 infection, and be currently hospitalized with symptoms of a respiratory infection. Unfortunately, certain conditions may exclude you from joining, such as if you are expected to leave the hospital soon or have other severe health issues. If you are eligible, you'll receive detailed information about what to expect during the trial, including how the treatment is given and regular check-ins to monitor your health. This study is currently recruiting participants, and your involvement could contribute to important advancements in treating COVID-19.
Gender
ALL
Eligibility criteria
- 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.
About University Of Minnesota
The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Morgantown, West Virginia, United States
Mather, California, United States
San Francisco, California, United States
Stanford, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Urbana, Illinois, United States
Springfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Santa Fe, New Mexico, United States
Bronx, New York, United States
Bronx, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Winston Salem, North Carolina, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Providence, Rhode Island, United States
Providence, Rhode Island, United States
Rapid City, South Dakota, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Loma Linda, California, United States
Sacramento, California, United States
San Francisco, California, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Long Island City, New York, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Salem, Virginia, United States
Singapore, , Singapore
Tucson, Arizona, United States
Tucson, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
Denver, Colorado, United States
Washington, District Of Columbia, United States
Orlando, Florida, United States
Kansas City, Kansas, United States
Bethesda, Maryland, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Omaha, Nebraska, United States
Bronx, New York, United States
New York, New York, United States
Potsdam, New York, United States
Longview, Texas, United States
San Antonio, Texas, United States
Toyoake, Aichi, Japan
Shinjuku Ku, Tokyo, Japan
Ivano Frankivs'k, Frankivs'k, Ukraine
Birmingham, Alabama, United States
Fresno, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Cincinnati, Ohio, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Tbilisi, , Georgia
Seongnam, Gyeonggi, Korea, Republic Of
Seocho, Seoul, Korea, Republic Of
Seoul, , Korea, Republic Of
Long Beach, California, United States
Gainesville, Florida, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Houston, Texas, United States
Spokane, Washington, United States
Westmead, New South Wales, Australia
Melbourne, Victoria, Australia
Aalborg, , Denmark
Copenhagen, , Denmark
Copenhagen, , Denmark
Hellerup, , Denmark
Hillerød, , Denmark
Hvidovre, , Denmark
Bangkok, , Thailand
Charleston, South Carolina, United States
Sydney, New South Wales, Australia
Kolding, , Denmark
Odense, , Denmark
Athens, Attica, Greece
Chicago, Illinois, United States
Cape Town, Western Cape, South Africa
Lebanon, New Hampshire, United States
Dallas, Texas, United States
Camden, New Jersey, United States
New York, New York, United States
Columbus, Ohio, United States
Warwick, Rhode Island, United States
Milwaukee, Wisconsin, United States
Heidelberg, Victoria, Australia
Aarhus, N, Denmark
Bonn, , Germany
Athens, Attica, Greece
Athens, Attica, Greece
Athens, Attica, Greece
Alexandroupolis, Evros, Greece
Seoul, , Korea, Republic Of
Durban, Kwazulu Natal, South Africa
Pietermaritzburg, Kwazulu Natal, South Africa
Khon Kaen, , Thailand
Entebbe, , Uganda
Lira, , Uganda
Newport Beach, California, United States
Aarhus, N, Denmark
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Gulu, , Uganda
San Francisco, California, United States
Cologne, , Germany
Roskilde, , Denmark
Portland, Oregon, United States
Badalona, Barcelona, Spain
Barcelona, , Spain
Barcelona, , Spain
Brooklyn, New York, United States
Mineola, New York, United States
Barcelona, , Spain
Kampala, , Uganda
Boston, Massachusetts, United States
Masaka, , Uganda
Madison, Wisconsin, United States
San Juan, , Puerto Rico
Newark, New Jersey, United States
Tampa, Florida, United States
Los Angeles, California, United States
New Haven, Connecticut, United States
Detroit, Michigan, United States
Albuquerque, New Mexico, United States
Santa Fe, , Argentina
Seattle, Washington, United States
Frankfurt, , Germany
Abuja, Fct, Nigeria
Newcastle Upon Tyne, , United Kingdom
London, , United Kingdom
Sao Paulo, Sp, Brazil
Osaka, , Japan
La Plata, Buenos Aires, Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
Warsaw, , Poland
Zurich, , Switzerland
Kyiv, , Ukraine
London, , United Kingdom
Córdoba, Cordoba, Argentina
Miami, Florida, United States
Hackensack, New Jersey, United States
Sao Paulo, Sp, Brazil
Criciuma, Sc, Brazil
Joinville, Sc, Brazil
Tbilisi, , Georgia
Liverpool, New South Wales, Australia
Marília, Sp, Brazil
Sao Paulo, Sp, Brazil
Flushing, New York, United States
Villa Regina, Rio Negro, Argentina
Rosario, Santa Fe, Argentina
Caxias Do Sul, Rs, Brazil
Porto Alegre, Rs, Brazil
São Paulo, Sp, Brazil
São Paulo, Sp, Brazil
Lima, , Peru
Lima, , Peru
Zhytomyr, , Ukraine
Sao Paulo, Sp, Brazil
Florianopolis, Sc, Brazil
Ivano Frankivs'k, , Ukraine
Harare, , Zimbabwe
Mexico City, Cdmx, Mexico
Oaxaca City, Oa, Mexico
Mexico City, Cdmx, Mexico
Chicago, Illinois, United States
Patients applied
Trial Officials
Cavan Reilly, PhD
Principal Investigator
University of Minnesota
Jason Baker, MD
Study Chair
University of Minnesota
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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