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

Not Applicable

Not yet recruiting

• Conditions: COVID - 19
• Interventions: Drug: Ratutrelvir (83-0060) non-randomised; Drug: Paxlovid; Drug: Ratutrelvir (83-0060)

• Registration Number: NCT07157007
• Lead Sponsor: Traws Pharma, Inc.

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.

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 participants with mild to moderate COVID-19.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2025-12
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ratutrelvir (83-0060) non-randomised	Ratutrelvir (83-0060) non-randomised	-
Paxlovid	Paxlovid	Standard of care
Ratutrelvir (83-0060)	Ratutrelvir (83-0060)	-

Primary Outcome Measures

Name	Time	Method
Safety based on adverse events incidence	28 days	Adverse events incidence will be described using descriptive statistics methods
Safety based on adverse events severity	28 days	Adverse events severity will be assessed by current version of CTCAE

Secondary Outcome Measures

Name	Time	Method
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)	11 days
PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)	11 days
PK characteristics of 83-0060 based on Time to Cmax ( Tmax)	11 days
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28	28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.	28 days