NCT07157007 Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
| NCT ID | NCT07157007 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Traws Pharma, Inc. |
| Condition | COVID - 19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-09-16 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07157007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COVID - 19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07157007 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07157007 currently recruiting?
Yes, NCT07157007 is actively recruiting participants. Contact the research team at kdokukina@eilenther.com for enrollment information.
Where is the NCT07157007 trial being conducted?
This trial is being conducted at Charlestown, Australia, Sydney, Australia, Brisbane, Australia, Torquay, Australia and 11 additional locations.
Who is sponsoring the NCT07157007 clinical trial?
NCT07157007 is sponsored by Traws Pharma, Inc.. The trial plans to enroll 90 participants.
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