NCT05279235

Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (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) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe 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. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility. Treatment and Assessment Period This is the general sequence of events during the 29-day 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), and * Complete all safety monitoring. * Blood samples collection

Conditions

• Moderate to Severe COVID-19

Interventions

Type	Name	Description
DRUG	JT001	Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
DRUG	JT001 placebo	Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
DRUG	Favipiravir	Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
DRUG	Favipiravir placebo	Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2022-03-15
• Last updated: 2023-02-08

Locations

2 sites across 2 countries: China, Uzbekistan