Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vigonvita Life Sciences
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• Participants who have a positive SARS-CoV-2 test result.

• Participants who have one or more mild or moderate COVID-19 symptoms.

• Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to the first dose; ≤5 days from the first onset of COVID-19 symptoms to the first dose.

• 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 or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.

• Capable of giving signed informed consent as described in Appendix 1 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 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.

• Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.

• Participants who have eye disease.

• Participants who have any of the following conditions when screening: ALT or AST>1.5 ULN; e GFR <60 mL/min.

• 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.

• Participant's use of contraindicated drugs in the Package Insert of Nirmatrelvir Tablet/Ritonavir Tablets.

• 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.