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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

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.

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)

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 District, Taoyuan, Taiwan
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, Taoyuan, Taiwan
Research Institute of Virology
Tashkent, Tashkent, Uzbekistan