The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.
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 This is the general sequence of events during the 29-day 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), and * Complete all safety monitoring. * Blood samples collection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
290
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Specialized lnfectious Diseases Hospital No2 of Zangiota District
Tashkent, Tashkent Region, Uzbekistan
progression of COVID-19
Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19\* or death from any cause, through Day 29
Time frame: Up to 29 days
AEs and SAEs
Safety assessments such as AEs and SAEs through Day 29
Time frame: Up to 29 days
Progress, Death
Percentage of participants who experience these events by Day 29 * Progress to critical COVID-19 * Death from any cause
Time frame: Up to 29 days
WHO 11-point ordinal outcome scale
The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
Time frame: Day 3, 5, 7, 10 and 29
The change of Chest CT scan
The change of Chest CT scan from baseline to Day 7 and 10(Percentage of lung involved)
Time frame: Day 7 and 10
SARS-CoV-2 clearance
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Time frame: Day 3, 5 ,7 and 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days