Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

NCT05279235 | Terminated Phase 3

• 1 other identifier: JT001-006-III-COVID-19
• Study Type: interventional
• Target: 290
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• progression of COVID-19

  Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19\* or death from any cause, through Day 29

  Up to 29 days

Secondary Outcomes (5)

• AEs and SAEs

  Up to 29 days

• Progress, Death

  Up to 29 days

• WHO 11-point ordinal outcome scale

  Day 3, 5, 7, 10 and 29

• The change of Chest CT scan

  Day 7 and 10

• SARS-CoV-2 clearance

  Day 3, 5 ,7 and 10

Other Outcomes (1)

• SARS-CoV-2 viral genetic variation

  Day 1

Study Arms (2)

JT001& Favipiravir Placebo

EXPERIMENTAL

JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

Drug: JT001; Drug: Favipiravir placebo

Favipiravir & JT001 Placebo

ACTIVE COMPARATOR

Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Drug: JT001 placebo; Drug: Favipiravir

Interventions

JT001 DRUG

Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Also known as: VV116

JT001& Favipiravir Placebo

JT001 placebo DRUG

Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Also known as: VV116 placebo

Favipiravir & JT001 Placebo

Favipiravir DRUG

Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

Favipiravir & JT001 Placebo

Favipiravir placebo DRUG

Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days

JT001& Favipiravir Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of 18 years of age or older, at the time of signing of informed consent
• Participants who have a positive SARS-CoV-2 test result
• Participants who have one or more COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
• Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
• Participants who must agree to adhere to contraception restrictions
• Participants who understand and agree to comply with planned study procedures
• Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

You may not qualify if:

• Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
• Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
• Participants who are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
• Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
• Participants who have any of the following conditions when screening:
• ALT or AST\>1.5 ULN
• Systolic blood pressure \< 90 mm Hg
• Diastolic blood pressure \< 60 mm Hg
• Requiring vasopressors
• Multi-organ dysfunction/failure
• Participants who have known allergies to any of the components used in the formulation of the interventions
• Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
• Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
• Participants who have received convalescent COVID-19 plasma treatment
• Participants who have received SARS-CoV-2 vaccine prior to randomization.

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

Specialized lnfectious Diseases Hospital No2 of Zangiota District

Tashkent, Tashkent Region, 1118, Uzbekistan

Location

MeSH Terms

Interventions

GS-621763; favipiravir

Study Officials

• Juan Ma, Master

  Shanghai Junshi Bioscience Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 15, 2022
• Study Start: March 14, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-02

Locations

CN (1); UZ (1)