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Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

NCT05279235 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Moderate to Severe COVID-19

Interventions

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

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Vinnerna Biosciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Ma, Master · Shanghai Junshi Bioscience Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2022-12-15
Completion
2022-12-15

Countries

  • China
  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279235 on ClinicalTrials.gov