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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07157007
- Acronym / sponsor ID
- 83-0060-0002
- Conditions
- COVID - 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
| Arm | Type | Receives |
|---|---|---|
| Ratutrelvir (83-0060) non-randomised | Experimental | Drug: Ratutrelvir (83-0060) non-randomised |
| Paxlovid | Active comparator | Drug: PaxlovidStandard of care |
| Ratutrelvir (83-0060) | Experimental | Drug: Ratutrelvir (83-0060) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ratutrelvir (83-0060) non-randomised83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) | Drug | Ratutrelvir (83-0060) non-randomised |
| PaxlovidPaxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor) | Drug | Paxlovid |
| Ratutrelvir (83-0060)83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) | Drug | Ratutrelvir (83-0060) |
Primary outcome
Safety based on adverse events incidence
Time frame: 28 days
Adverse events incidence will be described using descriptive statistics methods
Safety based on adverse events severity
Time frame: 28 days
Adverse events severity will be assessed by current version of CTCAE
5 secondary outcomes
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
Time frame: 28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
Time frame: 28 days
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
Time frame: 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
PK characteristics of 83-0060 based on Time to Cmax ( Tmax)
Time frame: 11 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea, Taiwan, Australia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Dokukina (+38269728309, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety based on adverse events incidence (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.