This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose forRatutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about thesafety of drug Ratutrelvir. Participants will take a study drug as well as a standardtherapy. A descriptive statistics will be used to present the study results.
This is a multicenter, open-label, randomized Phase 2a study to evaluate the safety and
efficacy of 83-0060 (Ratutrelvir) and Nirmatrelvir-Ritonavir (Paxlovid) in
non-hospitalized symptomatic adult participants with mild to moderate COVID-19.
Drug: Ratutrelvir (83-0060) non-randomised
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Drug: Paxlovid
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
Drug: Ratutrelvir (83-0060)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Inclusion Criteria:
1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
2. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to
randomization.
3. At least one of the symptoms attributable to COVID-19 present within 24 hours prior
to the Day 1 with the severity score of 1 or higher according to the following
scoring system for the assessment of severity of:
Exclusion Criteria:
Medical Conditions:
1. History, current need for hospitalization or anticipated need for hospitalization
for the medical treatment of COVID-19.
2. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure
ventilation, invasive mechanical ventilation or ECMO.
3. Known medical history of active liver disease .
4. Receiving dialysis or history of moderate to severe renal impairment.
5. Compromised immune system.
6. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic
obstructive pulmonary disease within 30 days before screening.
7. Suspected or confirmed concurrent active systemic infection..
Prior/Concomitant Therapy:
8. Has received or is expected to receive any dose of a SARS-CoV-2 vaccine within 4
months of screening and during the participation in the study.
9. Concomitant use of any medications or substances that are strong inducers of CYP3A4
Not Provided
Not Provided