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
Sydney, New South Wales, Australia
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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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