COVID-19
Conditions
Sponsors
Gomez JuanCarlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For mild/moderate SARS-CoV-2-infected participants: - Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomization. - Participants with time from COVID-19 onset to randomization of =< 120 hours. - Participants who have at least one moderate or severe symptom among the following 12 symptoms of COVID-19 at the time of randomization. (low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea) For asymptomatic SARS-CoV-2-infected participants (Phase 2a Part): - Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt. - Participants who have none of the following 14 symptoms of COVID-19 within 2 weeks before randomization. (low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, taste disorder, smell disorder, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea) For asymptomatic/only mild symptoms SARS-CoV-2-infected participants (Phase 2b/3 Part): - Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt. - Participants who do not have any symtoms of moderate or severe symptom among the 12 symptoms of COVID-19 at the time of randomization.
Exclusion criteria
Exclusion criteria: Common for Phase 2a Part and Phase 2b/3 Part And commmon for mild/moderate and asumptomatic SARS-CoV-2-infected participants - Participants with a percutaneous oxygen saturation (SpO2) during wakefulness of =< 93% (room air) - Participants strongly suspected to have pneumonia - Participants who need oxygen administration - Participants who need a mechanical ventilation - Participants who are strongly suspected to have worsening of symptoms of SARS-CoV-2 infection within 48 hours after randomization, in the opinion of the investigator/subinvestigator - Participants with suspected active and systemic infections requiring treatment at the time of randomization (excluding SARS-CoV-2) - Current or chronic history of moderate or severe liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) - Current or chronic history of moderate or severe kidney disease - Participants who have used any of the following drugs within 7 days prior to randomization (approved/unapproved drugs for the treatment of SARS-CoV-2 infection, antiviral, antibacterial, or antifungal drugs [excluding topical use]) - Participants who have used any of the following drugs within 14 days prior to randomization (strong CYP 3A inhibitor, strong CYP 3A inducer, products containing St. John's wort)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2a Part Change from baseline in SARS-CoV-2 viral titer at each time point Phase 2b Part Time-weighted average change in total score of 12 COVID-19 symptoms from Day 1 up to Day 6 Change from baseline on Day 4 in SARS-CoV-2 viral titer Phase 3 Part Time to resolution of 5 COVID-19 symptoms Change from baseline on Day 4 in the amount of SARS-CoV-2 viral RNA Time to the first negative SARS CoV-2 viral titer Phase 2b/3 Part Primary endpoint and key secondary endpoint are not set. | — |
Countries
Japan, Republic of Korea, Republic of Singapore, Socialist Republic of Vietnam
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed