COVID - 19Phase 2NCT07157007
Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
A Phase 2 study testing Ratutrelvir (83-0060) non-randomised, Paxlovid and Ratutrelvir (83-0060) in people with COVID - 19, run by Traws Pharma, Inc. at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID - 19
- What is being tested?
- Ratutrelvir (83-0060) non-randomised, Paxlovid and Ratutrelvir (83-0060)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 16 Sep 2025to Mar 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 4 countries
South Korea5 sites, 5 recruiting
- Not yet recruiting
Chonnam National University Hospital
Gwangju, Donggu, 61469
Kyung-Hwa Park, +82622206298, iammedkid@naver.com
- Not yet recruiting
Inha University Hospital
Incheon, Jung-gu, 22332
Jin-Soo Lee, 82328901150, ljinsoo@inha.ac.kr
- Not yet recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 07441
Sang-haak Lee, +82220303758, mdlee@catholic.ac.kr
- Not yet recruiting
Hallym University Sacred Heart Hospital Gangnam
Seoul, Seoul, 07441
Jacob Lee, litjacob@gmail.com
- Not yet recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Young-Keun Kim, +82337411209, amoxj@yonsei.ac.kr
Taiwan5 sites, 5 recruiting
- Not yet recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, Kaohsiung, 807
Yen-Hsu Chen, +886975356117, infchen@gmail.com
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, Taichung, 407
Po-Yu Liu, +8860963417010, liupoyu@gmail.com
- Not yet recruiting
Taipei Medical University Hospital
Taipei, Taipei, 110
Ming-Che Liu, +886227372181 ext. 8265, d204097002@tmu.edu.tw
- Not yet recruiting
Taoyuan General Hospital
Taoyuan, Taoyuan, 33004
Chien-Yu Cheng, +88633699721 ext. 8311, s841060@gm.ym.edu.tw
- Not yet recruiting
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taoyuan, 333
Ching-Tai Huang, +886975368179, chingtaihuang@gmail.com
Australia4 sites, 4 recruiting
- Recruiting
Momentum Clinical Research Taringa
Brisbane, Queensland, 4068
Paul Griffin, Prof, +61733796619, paul.griffin@momentumclinicalresearch.com.au
- Recruiting
Novatrial
Charlestown, New South Wales, 2290
Eliza Milliken, +61240010376, eliza.milliken@novatrials.com.au
- Recruiting
Key Health
Sydney, New South Wales, 2000
Aaron Wong, +61473404917, aaron.wong@keyhealth.com.au
- Not yet recruiting
Paratus Clinical(Clinical Trials Institute, Torquay)
Torquay, Victoria, 3228
Yagyadutt Gupta, +61342527023, Heenal.patel@paratusclinical.com
Uzbekistan1 site, 1 recruiting
- Recruiting
Research Institute of Virology
Tashkent, Tashkent, 100194
Erkin Isakovich Musabayev, +998712248326, drmusabaev1956@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID - 19
- Being tested
- Ratutrelvir (83-0060) non-randomised, Paxlovid, Ratutrelvir (83-0060)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ratutrelvir (83-0060) non-randomisedDrug
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
PaxlovidDrug
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
Ratutrelvir (83-0060)Drug
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
| Study group | Role | What they receive |
|---|---|---|
| Ratutrelvir (83-0060) non-randomised | Experimental | Not described Receives: Drug: Ratutrelvir (83-0060) non-randomised |
| Paxlovid | Active comparator | Standard of care Receives: Drug: Paxlovid |
| Ratutrelvir (83-0060) | Experimental | Not described Receives: Drug: Ratutrelvir (83-0060) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on adverse events incidence
Adverse events incidence will be described using descriptive statistics methods
Measured: 28 days
Safety based on adverse events severity
Adverse events severity will be assessed by current version of CTCAE
Measured: 28 days
Secondary outcomes (5)
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
Measured: 28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
Measured: 28 days
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
Measured: 11 days
PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)
Measured: 11 days
PK characteristics of 83-0060 based on Time to Cmax ( Tmax)
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start16 Sep 2025
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157007
- Sponsor's protocol ID
- 83-0060-0002
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No