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

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    2000
  • sponsor
    Shanghai JunTop Biosciences Co., LTD
Updated on 24 April 2022

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.

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

This is the general sequence of events during the 29-day 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), and
  • Complete all safety monitoring.
  • Blood samples collection

Phase Ⅱ Stage Analysis for Dose Selection The phase Ⅱ analysis will be conducted for dose selection when approximately 240 participants have reached Day 20, 15 days after last dose of IMP. The IDMC is authorized to review the un-blinded data and perform the dose selection and sample size re-evaluation for phase III. The details of decision criteria and decision-making procedure will be specified in the IDMC charter and associated documents.

The dose selection result would be 2 possibilities:

  1. A superior dose is selected for phase III stage with/without sample size increment;
  2. Study is terminated

Details
Condition Mild to Moderate COVID-19
Treatment Placebo, JT001
Clinical Study IdentifierNCT05242042
SponsorShanghai JunTop Biosciences Co., LTD
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who have a positive SARS-CoV-2 test result
Participants who have one or more mild or moderate COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
Participants who have sample collection for first positive SARS-CoV-2 viral infection determination and 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 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, 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 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
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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