NCT07157007

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

A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate Safety and Efficacy of Ratutrelvir and Standard of Care in Non-hospitalized Symptomatic Adult Participants With Mild to Moderate COVID-19

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID - 19

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-09-05
• Last updated: 2026-01-21

Locations

15 sites across 4 countries: Australia, South Korea, Taiwan, Uzbekistan