The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) 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 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 This is the general sequence of events during the 28-day treatment and assessment period: Complete baseline procedures and samples collection; Participants are randomized to experimental arm or placebo arm; 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
1,369
Fuzhou Pulmonary Hospital Of Fujian
Fuzhou, Fujian, China
The third people's hospital of Shenzhen
Shenzhen, Guangdong, China
Wuhan Infections Diseases Hospital
Wuhan, Hubei, China
The Fourth Hospital in Inner Mongolia
Hohhot, Inner Mongolia, China
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
Time to sustained clinical symptoms resolution
Time frame: Up to 28 days
Clinical alleviation
Time to sustained clinical symptoms alleviation
Time frame: Up to 28 days
Disease progression
Percentage of participants who experience the following events of disease progression through Day 28 COVID-19-related hospitalization in non-hospitalized participants Progression to severe COVID-19 Progression to critical COVID-19 Death from any cause
Time frame: Up to 28 days
SARS-CoV-2 nucleic acid and viral load
Percentage of participants who achieve SARS-CoV-2 negative through Days 5 and 7 Change of SARS-CoV-2 Ct Value from baseline to Days 5 and 7 Change of SARS-CoV-2 viral load from baseline to Days 5 and 7 SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
Time frame: Up to 28 days
Safety
Safety assessments such as AEs and SAEs through Day 28
Time frame: Up to 28 days
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The Sixth People's Hospital of ShenYang
Shenyang, Liaoning, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
Quzhou People's Hospital
Quzhou, Zhejiang, China