Status:
TERMINATED
Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Lead Sponsor:
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Moderate to Severe COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05279235
Start Date
March 14 2022
End Date
December 15 2022
Last Update
February 8 2023
Active Locations (2)
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1
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 201508
2
Specialized lnfectious Diseases Hospital No2 of Zangiota District
Tashkent, Tashkent Region, Uzbekistan, 1118