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JT001 (VV116) for the Early Treatment of COVID-19 | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

JT001 (VV116) for the Early Treatment of COVID-19

A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study 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 COVID-19.

NCT05242042•Shanghai JunTop Biosciences Co., LTD

View on ClinicalTrials.gov

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 COVID-19, at high risk for progression to severe COVID-19, including death.

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-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility. Treatment and Assessment Period * Complete baseline procedures and sample collection * Participants are randomized to an intervention group * Participants receive study intervention (Q12H X 5 days) * Complete all safety monitoring * Complete all efficacy data collection * Blood samples collection

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants of 18 years of age or older
•2. 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
•3. Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3
•4. Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization
•5. Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:
•6. Participants who must agree to adhere to contraception restrictions
•7. Participants who understand and agree to comply with planned study procedures
•8. 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 Criteria

•1. Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
•2. 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
•3. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
•4. 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
•5. Participants who have eye disease
•6. 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
+3 more criteria

Locations (8)

Chongqing Public Health Medical Center

Chongqing, Chongqing Municipality, China

Thesixth peoples Hospital Of ZhengZhou

Zhengzhou, Henan, China

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, China

The Sixth People's Hospital of ShenYang

Shenyang, Liaoning, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

CUHK Medical Centre

Hong Kong, Hong Kong

CUHK Phase 1 Clinical Trial Centre

Hong Kong, Hong Kong

Key Dates

Start Date

January 28, 2022

Primary Completion Date

March 23, 2023

Completion Date

March 23, 2023

Last Updated

September 22, 2023

Enrollment

381

ACTUAL participants

Conditions

Mild to Moderate COVID-19

Interventions

JT001

DRUG

Placebo

DRUG

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Mild to Moderate COVID-19

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TERMINATEDPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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