Back to resultsEfficacy and Safety of JT001 (VV116) Compared With Favipiravir
Primary Purpose
Moderate to Severe COVID-19
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JT001
JT001 placebo
Favipiravir
Favipiravir placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe COVID-19
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
- Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Female who is pregnant or breast-feeding or plan to be pregnant within this study period
- Male whose wife or partner plan to be pregnant within this study period
Sites / Locations
- Shanghai Public Health Clinical Center
- Specialized lnfectious Diseases Hospital No2 of Zangiota District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
JT001& Favipiravir Placebo
Favipiravir & JT001 Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
AEs and SAEs
Safety assessments such as AEs and SAEs through Day 29
Progress, Death
Percentage of participants who experience these events by Day 29
Progress to critical COVID-19
Death from any cause
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)
The change of Chest CT scan
The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）
SARS-CoV-2 clearance
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Full Information
NCT ID
NCT05279235
First Posted
March 8, 2022
Last Updated
February 6, 2023
Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05279235
Brief Title
Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Development strategy adjustment
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JT001& Favipiravir Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Favipiravir & JT001 Placebo
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
JT001
Other Intervention Name(s)
VV116
Intervention Description
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Intervention Type
Drug
Intervention Name(s)
JT001 placebo
Other Intervention Name(s)
VV116 placebo
Intervention Description
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
Intervention Type
Drug
Intervention Name(s)
Favipiravir placebo
Intervention Description
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
Primary Outcome Measure Information:
Title
progression of COVID-19
Description
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
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
AEs and SAEs
Description
Safety assessments such as AEs and SAEs through Day 29
Time Frame
Up to 29 days
Title
Progress, Death
Description
Percentage of participants who experience these events by Day 29
Progress to critical COVID-19
Death from any cause
Time Frame
Up to 29 days
Title
WHO 11-point ordinal outcome scale
Description
The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
Time Frame
Day 3, 5, 7, 10 and 29
Title
The change of Chest CT scan
Description
The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）
Time Frame
Day 7 and 10
Title
SARS-CoV-2 clearance
Description
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Time Frame
Day 3, 5 ,7 and 10
Other Pre-specified Outcome Measures:
Title
SARS-CoV-2 viral genetic variation
Description
SARS-CoV-2 viral genetic variation
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Female who is pregnant or breast-feeding or plan to be pregnant within this study period
Male whose wife or partner plan to be pregnant within this study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Ma, Master
Organizational Affiliation
Shanghai Junshi Bioscience Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
Specialized lnfectious Diseases Hospital No2 of Zangiota District
City
Tashkent
State/Province
Tashkent Province
ZIP/Postal Code
1118
Country
Uzbekistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Learn more about this trial
Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
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