SARS-CoV-2 infection
Conditions
Interventions
Oral administration of ensitrelvir granules once daily for 5 days
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant who was diagnosed as SARS-CoV-2 positive within 72 hours before enrollment -Participant who may be enrolled within 72 hours after COVID-19 onset -Participant who has at least one moderate or severe COVID-19 symptom at screening -Participant who the investigator (sub-investigator) judges to be able to take the study intervention. -Participant whose weight is less than 30 kg at the screening visit.
Exclusion criteria
Exclusion criteria: -Participant with SpO2 of <= 93% (room air) -Participant who weighed less than 2.5 kg at the screening visit, or who were under 1 year of age at the time of consent and weighed less than 2.5 kg at birth, or who were premature (born before 37 weeks). -Participant requiring oxygen treatment -Participant requiring mechanical ventilation -Participant who is strongly suspected to have worsening of SARS-CoV-2 infection symptoms within 48 hours after enrollment -Participant who is suspected to have active systemic infection requiring treatment -Participant who has or suspected to have MIS-C/PIMS -Participant who is known to have renal impairment with CrCl of < 30 mL/min by the Schwartz formula or requiring dialysis -Participant who has severe hepatic impairment -Participant who has history of epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse events, laboratory tests, vital signs -Plasma concentration of ensitrelvir | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed