NCT05582629

JT001 (VV116) for the Treatment of COVID-19

A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) in Participants With Mild to Moderate COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,369 (actual)
• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.

Detailed description

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

Conditions

• Mild to Moderate COVID-19

Interventions

Type	Name	Description
DRUG	JT001	JT001 administered orally in tablet form every 12 hours for 5 days
DRUG	Placebo	Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days

Timeline

• Start date: 2022-10-21
• Primary completion: 2023-02-14
• Completion: 2023-02-14
• First posted: 2022-10-17
• Last updated: 2023-06-28

Locations

9 sites across 1 country: China