Status:
TERMINATED
JT001 (VV116) for the Early Treatment of COVID-19
Lead Sponsor:
Shanghai JunTop Biosciences Co., LTD
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Mild to Moderate COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate...
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
- Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination ≤5 days prior to randomization
- Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3
- Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:
- Participants who must agree to adhere to contraception restrictions
- Participants who understand and agree to comply with planned study procedures
- Participants can give written informed consent approved by the Ethical Review Board governing the site and comply 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 severe/critical COVID-19 prior to randomization.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute, or heart rate ≥125 per minute
- 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
- Participants who have ALT or AST\>2 ULN at screening
- 7 Participants who have known allergies to any of the components used in the formulation of the interventions
- 8 Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
- 9\. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 180 days prior to screening visit
- 10\. Participants who have received convalescent COVID-19 plasma treatment
- 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
- 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
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2023
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT05242042
Start Date
January 28 2022
End Date
March 23 2023
Last Update
September 22 2023
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
2
Thesixth peoples Hospital Of ZhengZhou
Zhengzhou, Henan, China
3
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China
4
The Ninth Hospital of Nanchang
Nanchang, Jiangxi, China