A multicenter, Adaptive, Randomised, Controlled Trial Platform to Evaluated Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections
- Conditions
- Codes for special purposes
- Registration Number
- KCT0008328
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1. Confirmation of SARS-CoV-2 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.
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.
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 (see section 6.3 and protocol instruction materials)
3. Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
4. Known estimated glomerular filtration rate (eGRF) <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 child-bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
10. Inability to take investigational agent in tablet form by mouth.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Important safety endpoints include mortality; a composite of death, SAEs, and protocol-defined anticipated clinical events (PDACEs) through Days 5, 28, and 60; a composite of death, SAEs, PDACEs, and grade 3 or 4 AEs, assessed through Days 5, 28, and 60; the components of the composite safety outcomes will also be summarized.;Days to Recovery Scale
- Secondary Outcome Measures
Name Time Method mortality;a 3-category ordinal outcome, assessed at Day 60, with the following categories: recovered (alive and at home at Day 60), alive and not recovered, and dead;;proportion of participants who died or required new invasive mechanical ventilation.