COVID-19
Conditions
Interventions
Randomization to S-217622 plus standard of care or matched placebo plus standard of care in a 1:1 allocation. Study investigational agent/placebo (S-217622) will be administered as tablets with dosin
Sponsors
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this trial is called the "Days to Recovery Scale" assessed over 60 days (DRS-60). For this trial, the DRS-60 version of the CRS includes daily bins for time to recovery with additional categories for alive, not-recovered and death. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to discharge from the initial hospitalization 2.Days alive and home through the end of follow-up, 3.Proportion of participants who are alive and at home, and proportion of participants who are alive, at home and free of new supplemental oxygen at days 14, 28, and at end of follow-up (typically Day 60) if home oxygen use is assessed in a given trial. 4.CRS-28 5.Ordinal outcome (categories defined below), on Days 1-7, 14, and 28 1)Can independently undertake usual activities with minimal or no symptoms 2)Symptomatic and currently unable to independently undertake usual activities but no need of supplemental oxygen (or not above premorbid requirements) 3)Supplemental oxygen =4 liters/min (or >=4 liters/min above premorbid requirements, but not high-flow oxygen) 5)Non-invasive ventilation or high-flow oxygen 6)Invasive ventilation, extracorporeal membrane oxygenation (ECMO), mechanical circulatory support, or new receipt of renal replacement therapy 7)Death 6.Health-related quality of life by EuroQol (EQ-5D-5L) at the end of follow-up 1.Mortality (proportion of participants who died by Day 60) 2.A 3-category ordinal outcome, assessed at Day 60, with the following categories 1)recovered (alive and at home at Day 60) 2)alive and not recovered 3)dead 3.Days to recovery (corresponding to categories 0-60 of the DRS-60) 4.Proportion of participants who died or required new invasive mechanical ventilation. | — |
Countries
Argentina, Australia, Brazil, Denmark, Georgia, Germany, Greece, India, Ireland, Japan, Mexico, Nigeria, Peru, Poland, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Uganda, Ukraine, United Kingdom, United States, Zimbabwe
Contacts
Public ContactSho Saito
Japan Institute for Health Security National Center for Global Health and Medicine
Outcome results
None listed