Finding a safe and effective dose of Ratutrelvir for 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

This will test different doses of the antiviral Ratutrelvir given with standard treatment in adults with mild to moderate COVID-19 to find a safe and effective dose.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Traws Pharma, Inc. (Industry-sponsored)
• Locations: 15 sites (Charlestown, New South Wales and 14 other locations)
• Trial ID: NCT07157007 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized Phase 2a study enrolls non-hospitalized adults with confirmed mild to moderate COVID-19 within five days of symptom onset. Participants are assigned to receive one of several Ratutrelvir dosing regimens or nirmatrelvir-ritonavir (Paxlovid) alongside standard therapies and are followed for safety and clinical outcomes. The trial emphasizes dose-finding and safety, using descriptive statistics to summarize adverse events, symptom trajectories, and viral markers. Key measures include treatment-emergent adverse events, symptom severity scores, and viral clearance over the follow-up period.

Who should consider this trial

Good fit: Adults with laboratory-confirmed SARS-CoV-2 infection who developed mild to moderate symptoms within five days, are not hospitalized, and meet the study's safety criteria are the intended participants.

Not a fit: People who are hospitalized or need high-flow oxygen or mechanical ventilation, or who have active liver disease, moderate-to-severe renal impairment, or significant immunosuppression are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, Ratutrelvir could offer an additional oral antiviral option with an optimized dose that reduces symptoms and lowers the risk of progression to severe COVID-19.

How similar studies have performed: Nirmatrelvir-ritonavir (Paxlovid) and other oral protease inhibitors have reduced COVID-19 progression in prior studies, but Ratutrelvir is a newer agent with limited clinical data so far.

Eligibility criteria

Inclusion Criteria:

1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
2. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
3. 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:

1. History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.
2. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
3. Known medical history of active liver disease .
4. Receiving dialysis or history of moderate to severe renal impairment.
5. Compromised immune system.
6. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.
7. Suspected or confirmed concurrent active systemic infection..

   Prior/Concomitant Therapy:
8. 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.
9. Concomitant use of any medications or substances that are strong inducers of CYP3A4

Where this trial is running

Charlestown, New South Wales and 14 other locations

• Novatrial — Charlestown, New South Wales, Australia (Recruiting)
• Key Health — Sydney, New South Wales, Australia (Recruiting)
• Momentum Clinical Research Taringa — Brisbane, Queensland, Australia (Recruiting)
• Paratus Clinical(Clinical Trials Institute, Torquay) — Torquay, Victoria, Australia (Not_yet_recruiting)
• Chonnam National University Hospital — Gwangju, Donggu, South Korea (Not_yet_recruiting)
• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, Eunpyeong-gu, South Korea (Not_yet_recruiting)
• Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (Not_yet_recruiting)
• Inha University Hospital — Incheon, Jung-gu, South Korea (Not_yet_recruiting)
• Hallym University Sacred Heart Hospital Gangnam — Seoul, Seoul, South Korea (Not_yet_recruiting)
• Kaohsiung Medical University Hospital — Kaohsiung City, Kaohsiung, Taiwan (Not_yet_recruiting)
• Taichung Veterans General Hospital — Taichung, Taichung, Taiwan (Not_yet_recruiting)
• Taipei Medical University Hospital — Taipei, Taipei, Taiwan (Not_yet_recruiting)
• Taoyuan General Hospital — Taoyuan, Taoyuan, Taiwan (Not_yet_recruiting)
• Chang Gung Memorial Hospital, Linkou Branch — Taoyuan, Taoyuan, Taiwan (Not_yet_recruiting)
• Research Institute of Virology — Tashkent, Tashkent, Uzbekistan (Recruiting)

Study contacts

• Study coordinator: Ekaterina Dokukina

Conditions COVID - 19