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Clinical Trials in South Korea / NCT07157007
Recruiting Phase 2

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

NCT07157007 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2025-09-16
Last updated
2026-01-21

Condition(s) studied

COVID - 19

Investigational drug(s) / intervention(s)

Ratutrelvir (83-0060) non-randomisedPaxlovid →Ratutrelvir (83-0060)

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Novatrial Charlestown New South Wales Recruiting
Key Health Sydney New South Wales Recruiting
Momentum Clinical Research Taringa Brisbane Queensland Recruiting
Paratus Clinical(Clinical Trials Institute, Torquay) Torquay Victoria Not Yet Recruiting
Chonnam National University Hospital Gwangju Donggu Not Yet Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Eunpyeong-gu Not Yet Recruiting
Wonju Severance Christian Hospital Wŏnju Gangwon-do Not Yet Recruiting
Inha University Hospital Incheon Jung-gu Not Yet Recruiting
Hallym University Sacred Heart Hospital Gangnam Seoul Seoul Not Yet Recruiting
Kaohsiung Medical University Hospital Kaohsiung City Kaohsiung Not Yet Recruiting
Taichung Veterans General Hospital Taichung Taichung Not Yet Recruiting
Taipei Medical University Hospital Taipei Taipei Not Yet Recruiting
Taoyuan General Hospital Taoyuan Taoyuan Not Yet Recruiting
Chang Gung Memorial Hospital, Linkou Branch Taoyuan Taoyuan Not Yet Recruiting
Research Institute of Virology Tashkent Tashkent Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157007 on ClinicalTrials.gov ↗ ← All trials in South Korea