Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ratutrelvir (83-0060) non-randomised, Paxlovid, Ratutrelvir (83-0060).
- Who it may be relevant to
- Registry conditions: COVID - 19. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, South Korea, Taiwan, Uzbekistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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)
Primary outcome measures
- Safety based on adverse events incidence [Time frame: 28 days]
- Safety based on adverse events severity [Time frame: 28 days]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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:
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 5 centers
- Chonnam National University Hospital — Gwangju
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul
- Wonju Severance Christian Hospital — Wŏnju
- Inha University Hospital — Incheon
- Hallym University Sacred Heart Hospital Gangnam — Seoul
Taiwan · 5 centers
- Kaohsiung Medical University Hospital — Kaohsiung City
- Taichung Veterans General Hospital — Taichung
- Taipei Medical University Hospital — Taipei
- Taoyuan General Hospital — Taoyuan
- Chang Gung Memorial Hospital, Linkou Branch — Taoyuan
Australia · 4 centers
- Novatrial — Charlestown
- Key Health — Sydney
- Momentum Clinical Research Taringa — Brisbane
- Paratus Clinical(Clinical Trials Institute, Torquay) — Torquay
Uzbekistan · 1 center
- Research Institute of Virology — Tashkent
Identifiers
NCT: NCT07157007 · 83-0060-0002