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

Mild to Moderate COVID-19 Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• COVID-19
• Mild to Moderate COVID-19

• NCT number: NCT05242042
• Study type: Interventional
• Source: Shanghai JunTop Biosciences Co., LTD
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 28, 2022
• Completion date: March 23, 2023