The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate 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. Treatment and Assessment Period This is the general sequence of events during the 28-day treatment and assessment period: Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
822
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Time to sustained clinical recovery
Time to sustained clinical recovery up to 28 days.
Time frame: Up to 28 days
AEs and SAEs through Day 28
AEs and SAEs through Day 28
Time frame: Up to 28 days
Percentage of participants who experience these events by Day 28
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
Time frame: Day 1 to 28 days
Percentage of clinical recovery participants
Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
The change of "COVID-19 symptom scores" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
The change of WHO clinical progression scale
The change of "WHO clinical progression scale" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 10 and higher scores mean a worse clinical progression.
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with SARS-CoV-2 clearance
Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14
Time frame: Days 3, 5, 7, 10, 14
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Shanghai, Shanghai Municipality, China
ShuGuang Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The change of SARS-COV-2 Ct value
The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14
Time frame: Days 3, 5, 7, 10, 14
The change of Chest CT scan
The change of Chest CT scan from baseline to Days 7 or 10. The change from baseline involves not changed, getting worse, getting better as assessed by the investigator.
Time frame: Days 7 or 10
Percentage of the participants who have progression of COVID-19 though Day 28
Progress to severe and/or critical COVID-19; Death from any cause
Time frame: Up to 28 days
Percentage of participants whose "WHO clinical progression scale" reduced at least one level
Percentage of participants whose "WHO clinical progression scale" reduced at least one level from baseline to Days 3, 5, 7, 10, 14, 21 and 28. The score ranges from 0 to 10 and the higher scores mean a worse clinical progression level.
Time frame: Days 3, 5, 7, 10, 14, 21 and 28
Time to sustained clinical symptom resolution
Time to sustained clinical symptom resolution
Time frame: Up to 28 days
Percentage of participants with clinical symptom resolution
Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Time frame: Days 3, 5, 7, 10, 14, 21 and 28