This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.
Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
Known medical history of active liver disease .
Receiving dialysis or history of moderate to severe renal impairment.
Parallel
Ratutrelvir (83-0060) non-randomised
Drug83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Paxlovid
DrugPaxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
Ratutrelvir (83-0060)
Drug83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Safety based on adverse events incidence
Adverse events incidence will be described using descriptive statistics methods
Safety based on adverse events severity
Adverse events severity will be assessed by current version of CTCAE
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)
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