Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19 (NCT07157007) is a Phase 2 interventional studying COVID - 19, sponsored by Traws Pharma, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against COVID - 19 and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused COVID - 19 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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: Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Ratutrelvir (83-0060) non-randomised

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

DRUG

Paxlovid

Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)

DRUG

Ratutrelvir (83-0060)

83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Locations (15)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Novatrial

Charlestown, New South Wales, Australia

Key Health

Sydney, New South Wales, Australia

Momentum Clinical Research Taringa

Brisbane, Queensland, Australia

Paratus Clinical(Clinical Trials Institute, Torquay)

Torquay, Victoria, Australia

Chonnam National University Hospital

Gwangju, Donggu, South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inha University Hospital

Incheon, Jung-gu, South Korea

Hallym University Sacred Heart Hospital Gangnam

Seoul, Seoul, South Korea

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, Taiwan

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taipei, Taiwan

Taoyuan General Hospital

Taoyuan, Taoyuan, Taiwan

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan, Taoyuan, Taiwan

Research Institute of Virology

Tashkent, Tashkent, Uzbekistan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07157007), the sponsor (Traws Pharma, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07157007 clinical trial studying?

Who can participate in NCT07157007?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07157007?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07157007. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07157007. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.