COVID-19
Conditions
Sponsors
Portsmouth Simon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all participants: - Participants who are >= 18 years at the time of signing the informed consent. - Participants who were diagnosed as SARS-CoV-2 positive within 72 hours before randomization. - Participants with time from COVID-19 onset to randomization of == 92% on room air adjusted for altitude and obtained at rest by study staff within 24h prior to randomization. For high-risk participants: - Participants who are >= 65 years at the time of signing the informed consent. - Participants who are >= 18 years at the time of signing the informed consent with 1 of the following: Obesity (BMI>=30), Diabetes mellitus, Hypertension, Cardiovascular disease, Chronic lung disease (e.g., COPD, modrate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Chronic kideney disease (except for CrCl<30mL/min), Down syndrome, Sickle cell disease, Immunocompromising conditions or immunosuppressive treatments. For Standard-risk participants: - Participants at low risk for progression to severe COVID-19 are defined as <65 years of age and with none of the risk factors
Exclusion criteria
Exclusion criteria: - Participants who have history of hospitalization for the current SARS-CoV-2 infection. - Participants with current need for hospitalization or immediate medical attention in the opinion of the investigator. - Participants with current use of any medications prohibited with the study intervention, or use of any medication intended to treat symptomatic SARS-CoV-2 infection before randomization. - Participants with any comorbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization. - Known current renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or requiring dialysis. - Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). - Participants who have used any of the following drugs within 14 days prior to randomization (strong CYP 3A inducer, products containing St. John's wort)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The time to sustained symptom resolution | — |
Countries
Argentina, Brazil, Colombia, Egypt, Ghana, India, Japan, Kenya, Malawi, Mexico, Pakistan, Philippines, Poland, Puerto Rico, South Africa, Tanzania, Thailand, Turkey, Uganda, US, Zimbabwe
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed