Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

Vigonvita Life Sciences

Status and phase

Completed

Phase 3

Conditions

COVID-19

Treatments

Drug: JT001

Drug: Paxlovid

Study type

Interventional

Funder types

Industry

Identifiers

NCT05341609

JT001-010-COVID-19

Details and patient eligibility

About

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.

Full 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.

Treatment and Assessment Period

This is the general sequence of events during the 28-day treatment and assessment period:

Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring

Enrollment

822 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who have a positive SARS-CoV-2 test result.
Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score ≥ 2.
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; SARS-CoV-2 Ct Value ≤20 within 24 hours prior 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.