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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)
EU CTIS ID: 2022-501020-19-01
What this study is testing
The primary objective of the STRIVE platform is to facilitate the efficient and rigorous execution of randomised clinical trials investigating the safety and efficacy of therapeutic interventions or strategies for acute respiratory infections among hospitalised adults. Each trial within STRIVE will have its own objectives outlined in its trial specific appendix. The primary objective for each trial will be compared efficacy of the intervention or strategy under investigation with control for the chosen primary outcome among participants randomised in that trial. The primary objective of this trial is to determine if a 5-day treatment course with S-217622, versus placebo, improves clinical outcomes for patients hospitalized for the management of COVID-19, when given in combination with standard care.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 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 likely can't join if
- The patient is expected to be discharged from the hospital within the next 24 hours.
- 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.
See the full eligibility 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 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
- The patient is expected to be discharged from the hospital within the next 24 hours.
- 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. NOTE: the exclusion criterion for patients unable to take the oral formulation of S-217622 (or placebo) may be removed if stability testing supports enteral administration of crushed tablets. If available data supports enteral administration of S-217622 (or placebo), then this exclusion would be removed and patients unable to take oral tablets would be eligible, e.g., those on invasive mechanical ventilation or ECMO
- Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Japan
- Mozambique
- United Kingdom
- South Africa
- United States
- Korea, Republic of
- Peru
- Ukraine
- Uganda
- Argentina
- Singapore
- Georgia
- Brazil
- Mexico
- Nigeria
- Australia
- India
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Japan; Mozambique; United Kingdom; South Africa; United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.