JPRN-jRCT2031220667RecruitingPhase 3
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory InfectionsAppendix E-1: Shionogi Protease Inhibitor S-217622(Ensitrelvir)
Ohmagari Norio0 sites50 target enrollmentStarted: February 28, 2023Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1.Age >=18 years.
- •2.Informed consent for trial participation.
- •3.Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
- •1.Confirmation of SARS-CoV-2 infection by nucleic acid test (NAT) or equivalent non-NAT test collected within the prior 14 days.
- •2.Onset of symptoms attributable to SARS-CoV-2 infection occurred within 14 days before randomization.
- •3.Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
Exclusion Criteria
- •1.The patient is expected to be discharged from the hospital within the next 24 hours.
- •2.Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
- •3.Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
- •4.Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life.
- •5.Expected inability or unwillingness to participate in study procedures.
- •6.In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
- •1.Allergy to investigational agent or vehicle
- •2.Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
- •3.Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
- •4.Known estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- •5.Continuous renal replacement therapy or chronic dialysis
- •6.Current pregnancy
- •7.Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
- •8.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.
- •9.Men who are unwilling to abstain from sexual intercourse with women of childbearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
Investigators
Similar Trials
Recruiting
Unknown
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory InfectionsCodes for special purposesKCT0008917Seoul National University Bundang Hospital50
Recruiting
Phase 1
A Multicenter, Adaptive, Randomized, Controlled Trial Platform to Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) - Shionogi Protease Inhibitor (S-217622)COVID-19MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862CTIS2022-501020-19-01niversity Of Minnesota1,520
Recruiting
Phase 1
A Multicenter, Adaptive, Randomized, Controlled Trial Platform to Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) - Immune Modulation Strategy TrialCOVID-19MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862CTIS2023-504487-41-00niversity Of Minnesota1,520
Recruiting
Unknown
A multicenter, Adaptive, Randomised, Controlled Trial Platform to Evaluated Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory InfectionsCodes for special purposesKCT0008328Seoul National University Bundang Hospital50
Active, not recruiting
Phase 1
Evaluation of Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19Patients hospitalized for COVID-19 and enrolled within 72 hours of hospital admittance or 72 hours of positive COVID testMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-004285-19-ITCONSORZIO FUTURO IN RICERCA2,000