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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242042
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
Sponsor GmbH
Information provided by (Responsible Party):
Shanghai JunTop Biosciences Co., LTD

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mild to Moderate COVID-19 Drug: JT001 Drug: Placebo Phase 2 Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 28, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : December 18, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: JT001
JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
Other Name: VV116
Placebo Comparator: Arm 2 Drug: Placebo
Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)


Outcome Measures
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Primary Outcome Measures :
  1. progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause [ Time Frame: Up to 28 days ]
    1. Percentage of the participants who have progression of COVID-19
    2. Time to sustained clinical symptom resolution


Secondary Outcome Measures :
  1. Overall participant clinical status [ Time Frame: Up to 28 days ]

    Percentage of participants who experience these events by Day 28

    • Progress to severe COVID-19
    • Progress to critical COVID-19
    • Death from any cause

  2. COVID-19-related hospitalization rate of non-hospitalized participants [ Time Frame: Up to 28 days ]
    Percentage of participants who experience COVID-19-related hospitalization by Day 28

  3. SARS-CoV-2 negative rate through Day7 [ Time Frame: Baseline through Day 7 ]
    Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7

  4. The plasma concentration [ Time Frame: Baseline through Day 5 ]
    The plasma concentration of JT001 (VV116) and major metabolites

  5. Safety assessments [ Time Frame: Up to 28 days ]
    Safety assessments such as AEs and SAEs

  6. SARS-CoV-2 viral load [ Time Frame: Baseline through Day 7 ]
    The SARS-CoV-2 viral load change from baseline to Day 5 and 7

  7. SARS-CoV-2 viral load [ Time Frame: Baseline through Day 7 ]
    SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7

  8. To assess SARS-CoV-2 viral genetic variation [ Time Frame: Day 1 ]
    SARS-CoV-2 viral genetic variation


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

11. 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

12.Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242042


Contacts
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Contact: Jie Wang, Project Manager 8618036618073 jie_wang5@junshipharma.com
Contact: Yali Pan, Project Directer 8618621590299 yali_pan@junshipharma.com

Locations
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China, Chongqing
Chongqing Public Health Medical Center Not yet recruiting
Chongqing, Chongqing, China
Contact: Yaokai Chen         
China, Henan
Thesixth peoples Hospital Of ZhengZhou Not yet recruiting
Zhengzhou, Henan, China
Contact: Qingxia Zhao         
China, Jiangsu
Wuxi No.5 People's Hospital Not yet recruiting
Wuxi, Jiangsu, China
Contact: Xiufeng Jiang         
China, Jiangxi
The Ninth Hospital of Nanchang Recruiting
Nanchang, Jiangxi, China
Contact: Long Xu         
China, Liaoning
The Sixth People's Hospital of ShenYang Not yet recruiting
Shenyang, Liaoning, China
Contact: Hongyan Liu         
China, Shanghai
Shanghai Public Health Clinical Center Not yet recruiting
Shanghai, Shanghai, China, 201508
Contact: Yinzhong Shen, Doctor    8618916113951    shenyinzhong@shphc.org.cn   
Principal Investigator: Wenhong Zhang, Doctor         
Principal Investigator: Yinzhong Shen, Doctor         
Hong Kong
CUHK Medical Centre Recruiting
Hongkong, Hong Kong
Contact: Andrea Luk         
CUHK Phase 1 Clinical Trial Centre Recruiting
Hongkong, Hong Kong
Contact: Andrea Luk         
Sponsors and Collaborators
Shanghai JunTop Biosciences Co., LTD
Sponsor GmbH
Investigators
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Study Director: Juan Ma, Medical Director Shanghai JunTop Biosciences Co., LTD
More Information
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Responsible Party: Shanghai JunTop Biosciences Co., LTD
ClinicalTrials.gov Identifier: NCT05242042    
Other Study ID Numbers: JT001-004-II/III-COVID-19
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases