NCT05242042

JT001 (VV116) for the Early Treatment of COVID-19

A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study 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.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Shanghai JunTop Biosciences Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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, 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

Conditions

• Mild to Moderate COVID-19

Interventions

Type	Name	Description
DRUG	JT001	JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
DRUG	Placebo	Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)

Timeline

• Start date: 2022-01-28
• Primary completion: 2023-03-23
• Completion: 2023-03-23
• First posted: 2022-02-16
• Last updated: 2023-09-22

Locations

8 sites across 2 countries: China, Hong Kong