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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
Novatrial
Charlestown, New South Wales, Australia
RECRUITINGKey Health
Safety based on adverse events incidence
Adverse events incidence will be described using descriptive statistics methods
Time frame: 28 days
Safety based on adverse events severity
Adverse events severity will be assessed by current version of CTCAE
Time frame: 28 days
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
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Sydney, New South Wales, Australia
Momentum Clinical Research Taringa
Brisbane, Queensland, Australia
RECRUITINGParatus Clinical(Clinical Trials Institute, Torquay)
Torquay, Victoria, Australia
NOT_YET_RECRUITINGChonnam National University Hospital
Gwangju, Donggu, South Korea
NOT_YET_RECRUITINGThe Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea
NOT_YET_RECRUITINGWonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
NOT_YET_RECRUITINGInha University Hospital
Incheon, Jung-gu, South Korea
NOT_YET_RECRUITINGHallym University Sacred Heart Hospital Gangnam
Seoul, Seoul, South Korea
NOT_YET_RECRUITINGKaohsiung Medical University Hospital
Kaohsiung City, Kaohsiung, Taiwan
NOT_YET_RECRUITING...and 5 more locations