The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death.
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures. The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility. Treatment and Assessment Period * Complete baseline procedures and sample collection * Participants are randomized to an intervention group * Participants receive study intervention (Q12H X 5 days) * Complete all safety monitoring * Complete all efficacy data collection * Blood samples collection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
381
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
Thesixth peoples Hospital Of ZhengZhou
Zhengzhou, Henan, China
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, China
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
1. Percentage of the participants who have progression of COVID-19 2. Time to sustained clinical symptom resolution
Time frame: Up to 28 days
Overall participant clinical status
Percentage of participants who experience these events by Day 28 * Progress to severe COVID-19 * Progress to critical COVID-19 * Death from any cause
Time frame: Up to 28 days
COVID-19-related hospitalization rate of non-hospitalized participants
Percentage of participants who experience COVID-19-related hospitalization by Day 28
Time frame: Up to 28 days
SARS-CoV-2 negative rate through Day7
Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7
Time frame: Baseline through Day 7
The plasma concentration
The plasma concentration of JT001 (VV116) and major metabolites
Time frame: Baseline through Day 5
Safety assessments
Safety assessments such as AEs and SAEs
Time frame: Up to 28 days
SARS-CoV-2 viral load
The SARS-CoV-2 viral load change from baseline to Day 5 and 7
Time frame: Baseline through Day 7
SARS-CoV-2 viral load
SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
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The Sixth People's Hospital of ShenYang
Shenyang, Liaoning, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
CUHK Medical Centre
Hong Kong, Hong Kong
CUHK Phase 1 Clinical Trial Centre
Hong Kong, Hong Kong
Time frame: Baseline through Day 7
To assess SARS-CoV-2 viral genetic variation
SARS-CoV-2 viral genetic variation
Time frame: Day 1