Status:
RECRUITING
Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
Lead Sponsor:
Traws Pharma, Inc.
Conditions:
COVID - 19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Partic...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07157007
Start Date
September 16 2025
End Date
January 1 2026
Last Update
December 3 2025
Active Locations (15)
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1
Novatrial
Charlestown, New South Wales, Australia, 2290
2
Key Health
Sydney, New South Wales, Australia, 2000
3
Momentum Clinical Research Taringa
Brisbane, Queensland, Australia, 4068
4
Paratus Clinical(Clinical Trials Institute, Torquay)
Torquay, Victoria, Australia, 3228