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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05605093

Run by

University of Minnesota

People needed

602

Starts

2022-12-23

Expected to finish

2025-10-28

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• University of Alabama Birmingham University Hospital (Site 213-002) — Birmingham, Alabama, United States
• Banner University Medical Center Tucson (Site 206-004) — Tucson, Arizona, United States
• Southern Arizona VA Healthcare System (Site 074-009) — Tucson, Arizona, United States
• UCSF Fresno (Site 203-005) — Fresno, California, United States
• VA Loma Linda Healthcare System (Site 074-017) — Loma Linda, California, United States
• MemorialCare Health System (Site 066-003 — Long Beach, California, United States
• VA Long Beach Healthcare System (Site 074-026) — Long Beach, California, United States
• Cedars-Sinai Medical Center (Site 208-002) — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center (Site 203-002) — Los Angeles, California, United States
• VA Northern California Health Care System (Site 074-023) — Mather, California, United States
• Hoag Memorial Hospital Presbyterian (Site 080-026) — Newport Beach, California, United States
• Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005) — Palo Alto, California, United States
• UC Davis Health (Site 203-004) — Sacramento, California, United States
• VA San Diego Healthcare System (Site 074-016) — San Diego, California, United States
• Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007) — San Francisco, California, United States
• UCSF Medical Center at Mount Zion (203-007) — San Francisco, California, United States
• San Francisco VAMC (Site 074-002) — San Francisco, California, United States
• University of California San Francisco (Site 203-001) — San Francisco, California, United States
• Stanford University Hospital & Clinics (Site 203-003) — Stanford, California, United States
• Lundquist Institute for Biomedical Innovation (Site 066-002) — Torrance, California, United States
• Rocky Mountain Regional VA Medical Center (Site 074-010) — Aurora, Colorado, United States
• University of Colorado Hospital (Site 204-001) — Aurora, Colorado, United States
• Public Health Institute at Denver Health (Site 017-004) — Denver, Colorado, United States
• Yale University (Site 025-001) — New Haven, Connecticut, United States
• Hospital del Mar (626-025) — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.