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

Primary Purpose

Mild to Moderate COVID-19

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JT001
Placebo
Sponsored by
Shanghai JunTop Biosciences Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Chongqing Public Health Medical Center
  • Thesixth peoples Hospital Of ZhengZhou
  • Wuxi No.5 People's Hospital
  • The Ninth Hospital of Nanchang
  • The Sixth People's Hospital of ShenYang
  • Shanghai Public Health Clinical Center
  • CUHK Medical Centre
  • CUHK Phase 1 Clinical Trial Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
Percentage of the participants who have progression of COVID-19 Time to sustained clinical symptom resolution

Secondary Outcome Measures

Overall participant clinical status
Percentage of participants who experience these events by Day 28 Progress to severe COVID-19 Progress to critical COVID-19 Death from any cause
COVID-19-related hospitalization rate of non-hospitalized participants
Percentage of participants who experience COVID-19-related hospitalization by Day 28
SARS-CoV-2 negative rate through Day7
Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7
The plasma concentration
The plasma concentration of JT001 (VV116) and major metabolites
Safety assessments
Safety assessments such as AEs and SAEs
SARS-CoV-2 viral load
The SARS-CoV-2 viral load change from baseline to Day 5 and 7
SARS-CoV-2 viral load
SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
To assess SARS-CoV-2 viral genetic variation
SARS-CoV-2 viral genetic variation

Full Information

First Posted
February 11, 2022
Last Updated
September 20, 2023
Sponsor
Shanghai JunTop Biosciences Co., LTD
Collaborators
Sponsor GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05242042
Brief Title
JT001 (VV116) for the Early Treatment of COVID-19
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Based on the current number of COVID-19 cases and the approval of COVID-19 treatment drugs , the research team is facing great challenges, and it is decided to terminate this study
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai JunTop Biosciences Co., LTD
Collaborators
Sponsor GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JT001
Other Intervention Name(s)
VV116
Intervention Description
JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
Primary Outcome Measure Information:
Title
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
Description
Percentage of the participants who have progression of COVID-19 Time to sustained clinical symptom resolution
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Overall participant clinical status
Description
Percentage of participants who experience these events by Day 28 Progress to severe COVID-19 Progress to critical COVID-19 Death from any cause
Time Frame
Up to 28 days
Title
COVID-19-related hospitalization rate of non-hospitalized participants
Description
Percentage of participants who experience COVID-19-related hospitalization by Day 28
Time Frame
Up to 28 days
Title
SARS-CoV-2 negative rate through Day7
Description
Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7
Time Frame
Baseline through Day 7
Title
The plasma concentration
Description
The plasma concentration of JT001 (VV116) and major metabolites
Time Frame
Baseline through Day 5
Title
Safety assessments
Description
Safety assessments such as AEs and SAEs
Time Frame
Up to 28 days
Title
SARS-CoV-2 viral load
Description
The SARS-CoV-2 viral load change from baseline to Day 5 and 7
Time Frame
Baseline through Day 7
Title
SARS-CoV-2 viral load
Description
SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
Time Frame
Baseline through Day 7
Title
To assess SARS-CoV-2 viral genetic variation
Description
SARS-CoV-2 viral genetic variation
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of 18 years of age or older 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 Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3 Participants with 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 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Ma, Medical Director
Organizational Affiliation
Shanghai JunTop Biosciences Co., LTD
Official's Role
Study Director
Facility Information:
Facility Name
Chongqing Public Health Medical Center
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Thesixth peoples Hospital Of ZhengZhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
The Ninth Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Sixth People's Hospital of ShenYang
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
CUHK Medical Centre
City
Hongkong
Country
Hong Kong
Facility Name
CUHK Phase 1 Clinical Trial Centre
City
Hongkong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

Learn more about this trial

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

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