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RECRUITING
NCT07157007
PHASE2

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

Sponsor: Traws Pharma, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-09-16

Completion Date

2026-03

Last Updated

2026-01-21

Healthy Volunteers

No

Conditions

Interventions

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)

Locations (15)

Novatrial

Charlestown, New South Wales, Australia

Key Health

Sydney, New South Wales, Australia

Momentum Clinical Research Taringa

Brisbane, Queensland, Australia

Paratus Clinical(Clinical Trials Institute, Torquay)

Torquay, Victoria, Australia

Chonnam National University Hospital

Gwangju, Donggu, South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inha University Hospital

Incheon, Jung-gu, South Korea

Hallym University Sacred Heart Hospital Gangnam

Seoul, Seoul, South Korea

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, Taiwan

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taipei, Taiwan

Taoyuan General Hospital

Taoyuan District, Taoyuan, Taiwan

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, Taoyuan, Taiwan

Research Institute of Virology

Tashkent, Tashkent, Uzbekistan