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

January 17, 2026 updated by: Traws Pharma, Inc.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
      • Sydney, New South Wales, Australia, 2000
    • Queensland
    • Victoria
      • Torquay, Victoria, Australia, 3228
        • Not yet recruiting
        • Paratus Clinical(Clinical Trials Institute, Torquay)
        • Contact:
  • South Korea
    • Donggu
      • Gwangju, Donggu, South Korea, 61469
        • Not yet recruiting
        • Chonnam National University Hospital
        • Contact:
    • Eunpyeong-gu
      • Seoul, Eunpyeong-gu, South Korea, 07441
        • Not yet recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Contact:
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Not yet recruiting
        • Wonju Severance Christian Hospital
        • Contact:
    • Jung-gu
      • Incheon, Jung-gu, South Korea, 22332
        • Not yet recruiting
        • Inha University Hospital
        • Contact:
    • Seoul
      • Seoul, Seoul, South Korea, 07441
        • Not yet recruiting
        • Hallym University Sacred Heart Hospital Gangnam
        • Contact:
  • Taiwan
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University Hospital
        • Contact:
    • Taichung
      • Taichung, Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
    • Taipei
      • Taipei, Taipei, Taiwan, 110
        • Not yet recruiting
        • Taipei Medical University Hospital
        • Contact:
    • Taoyuan
      • Taoyuan District, Taoyuan, Taiwan, 33004
        • Not yet recruiting
        • Taoyuan General Hospital
        • Contact:
      • Taoyuan District, Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Memorial Hospital, Linkou Branch
        • Contact:
  • Uzbekistan
    • Tashkent
      • Tashkent, Tashkent, Uzbekistan, 100194
        • Recruiting
        • Research Institute of Virology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ratutrelvir (83-0060) non-randomised
Drug: Ratutrelvir (83-0060) non-randomised
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Active Comparator: Paxlovid
Standard of care
Drug: Paxlovid
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
Experimental: Ratutrelvir (83-0060)
Drug: Ratutrelvir (83-0060)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety based on adverse events incidence
Time Frame: 28 days
Adverse events incidence will be described using descriptive statistics methods
28 days
Safety based on adverse events severity
Time Frame: 28 days
Adverse events severity will be assessed by current version of CTCAE
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Traws Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

September 3, 2025

First Posted (Actual)

September 5, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83-0060-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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