NCT05341609

Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 822 (actual)
• Sponsor: Vigonvita Life Sciences · 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) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) 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, 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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	JT001	Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
DRUG	Paxlovid	Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-05-13
• Completion: 2022-05-31
• First posted: 2022-04-22
• Last updated: 2022-09-21

Locations

7 sites across 1 country: China