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)

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.

Study Overview

• Status: Terminated
• Conditions: Moderate to Severe COVID-19
• Intervention / Treatment: Drug: JT001; Drug: Favipiravir placebo; Drug: JT001 placebo; Drug: Favipiravir

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

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center
• Uzbekistan
  • Tashkent Province
    • Tashkent, Tashkent Province, Uzbekistan, 1118
      • Specialized lnfectious Diseases Hospital No2 of Zangiota District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants of 18 years of age or older, at the time of signing of informed consent
2. Participants who have a positive SARS-CoV-2 test result
3. 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
4. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
5. Participants who must agree to adhere to contraception restrictions
6. Participants who understand and agree to comply with planned study procedures
7. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
8. 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

Exclusion Criteria:

1. Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
2. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
3. 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
4. Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)

5. 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
6. Participants who have known allergies to any of the components used in the formulation of the interventions
7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
9. Participants who have received convalescent COVID-19 plasma treatment
10. Participants who have received SARS-CoV-2 vaccine prior to randomization.
11. Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
12. Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period
14. Male whose wife or partner plan to be pregnant within this study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JT001& Favipiravir Placebo; 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; Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days; Other Names: VV116; Drug: Favipiravir placebo; Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
ACTIVE_COMPARATOR: Favipiravir & JT001 Placebo; 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; Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days; Other Names: VV116 placebo; Drug: Favipiravir; Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs and SAEs	Safety assessments such as AEs and SAEs through Day 29	Up to 29 days
Progress, Death	Percentage of participants who experience these events by Day 29; Progress to critical COVID-19; Death from any cause	Up to 29 days
WHO 11-point ordinal outcome scale	The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)	Day 3, 5, 7, 10 and 29
The change of Chest CT scan	The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）	Day 7 and 10
SARS-CoV-2 clearance	Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10	Day 3, 5 ,7 and 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 viral genetic variation	SARS-CoV-2 viral genetic variation	Day 1

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Collaborators: Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2022
• Primary Completion (ACTUAL): December 15, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (ACTUAL): March 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: JT001-006-III-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No