Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19

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.

Inclusion criteria

• 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.
• 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:

• 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.
• Compromised immune system.
• Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.
• Suspected or confirmed concurrent active systemic infection..

Prior/Concomitant Therapy:

• 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.
• Concomitant use of any medications or substances that are strong inducers of CYP3A4