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
1 other identifier
interventional
90
4 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2025
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 5, 2025
CompletedStudy Start
First participant enrolled
September 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJanuary 21, 2026
January 1, 2026
5 months
September 3, 2025
January 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Safety based on adverse events incidence
Adverse events incidence will be described using descriptive statistics methods
28 days
Safety based on adverse events severity
Adverse events severity will be assessed by current version of CTCAE
28 days
Secondary Outcomes (5)
Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
28 days
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
11 days
PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)
11 days
PK characteristics of 83-0060 based on Time to Cmax ( Tmax)
11 days
Study Arms (3)
Ratutrelvir (83-0060) non-randomised
EXPERIMENTALPaxlovid
ACTIVE COMPARATORStandard of care
Ratutrelvir (83-0060)
EXPERIMENTALInterventions
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novatrial
Charlestown, New South Wales, 2290, Australia
Key Health
Sydney, New South Wales, 2000, Australia
Momentum Clinical Research Taringa
Brisbane, Queensland, 4068, Australia
Paratus Clinical(Clinical Trials Institute, Torquay)
Torquay, Victoria, 3228, Australia
Chonnam National University Hospital
Gwangju, Donggu, 61469, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 07441, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Inha University Hospital
Incheon, Jung-gu, 22332, South Korea
Hallym University Sacred Heart Hospital Gangnam
Seoul, Seoul, 07441, South Korea
Kaohsiung Medical University Hospital
Kaohsiung City, Kaohsiung, 807, Taiwan
Taichung Veterans General Hospital
Taichung, Taichung, 407, Taiwan
Taipei Medical University Hospital
Taipei, Taipei, 110, Taiwan
Taoyuan General Hospital
Taoyuan District, Taoyuan, 33004, Taiwan
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, Taoyuan, 333, Taiwan
Research Institute of Virology
Tashkent, Tashkent, 100194, Uzbekistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 5, 2025
Study Start
September 16, 2025
Primary Completion
February 1, 2026
Study Completion
March 1, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share