Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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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

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

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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JT001(VV116)

Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Group Type EXPERIMENTAL

JT001

Intervention Type DRUG

Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Paxlovid

Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Group Type ACTIVE_COMPARATOR

Paxlovid

Intervention Type DRUG

Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Interventions

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JT001

Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Intervention Type DRUG

Paxlovid

Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days

Intervention Type DRUG

Other Intervention Names

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VV116 Nirmatrelvir / ritonavir

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No