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
Traws Pharma, Inc.
90 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- 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
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Interventions
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07157007