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)
Overview
- Phase
- Phase 3
- Intervention
- JT001
- Conditions
- Moderate to Severe COVID-19
- Sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Enrollment
- 290
- Locations
- 2
- Primary Endpoint
- progression of COVID-19
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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
Investigators
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
Arms & Interventions
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
Intervention: JT001
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
Intervention: Favipiravir placebo
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
Intervention: JT001 placebo
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
Intervention: Favipiravir
Outcomes
Primary Outcomes
progression of COVID-19
Time Frame: Up to 29 days
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 Outcomes
- AEs and SAEs(Up to 29 days)
- WHO 11-point ordinal outcome scale(Day 3, 5, 7, 10 and 29)
- SARS-CoV-2 clearance(Day 3, 5 ,7 and 10)
- Progress, Death(Up to 29 days)
- The change of Chest CT scan(Day 7 and 10)