search
Back to results

Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JT001
Paxlovid
Sponsored by
Vigonvita Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring JT001(VV116), Mild to Moderate COVID-19

Eligibility Criteria

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

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.

Sites / Locations

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai Tongren Hospital
  • Shanghai Public Health Clinical Center
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • ShuGuang Hospital
  • Shanghai Pudong Hospital
  • Huashan Hospital affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JT001(VV116)

Paxlovid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to sustained clinical recovery
Time to sustained clinical recovery up to 28 days.

Secondary Outcome Measures

AEs and SAEs through Day 28
AEs and SAEs through Day 28
Percentage of participants who experience these events by Day 28
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
Percentage of clinical recovery participants
Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28
The change of COVID-19 symptom scores
The change of "COVID-19 symptom scores" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.
The change of WHO clinical progression scale
The change of "WHO clinical progression scale" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 10 and higher scores mean a worse clinical progression.
Percentage of participants with SARS-CoV-2 clearance
Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14
The change of SARS-COV-2 Ct value
The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14
The change of Chest CT scan
The change of Chest CT scan from baseline to Days 7 or 10. The change from baseline involves not changed, getting worse, getting better as assessed by the investigator.
Percentage of the participants who have progression of COVID-19 though Day 28
Progress to severe and/or critical COVID-19; Death from any cause
Percentage of participants whose "WHO clinical progression scale" reduced at least one level
Percentage of participants whose "WHO clinical progression scale" reduced at least one level from baseline to Days 3, 5, 7, 10, 14, 21 and 28. The score ranges from 0 to 10 and the higher scores mean a worse clinical progression level.
Time to sustained clinical symptom resolution
Time to sustained clinical symptom resolution
Percentage of participants with clinical symptom resolution
Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28

Full Information

First Posted
April 16, 2022
Last Updated
September 18, 2022
Sponsor
Vigonvita Life Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05341609
Brief Title
Efficacy and Safety of JT001 (VV116) Compared With Paxlovid
Official Title
A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vigonvita Life Sciences

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 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.
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. Treatment and Assessment Period This is the general sequence of events during the 28-day treatment and assessment period: Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
JT001(VV116), Mild to Moderate COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
822 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JT001(VV116)
Arm Type
Experimental
Arm Description
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Arm Title
Paxlovid
Arm Type
Active Comparator
Arm Description
Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days
Intervention Type
Drug
Intervention Name(s)
JT001
Other Intervention Name(s)
VV116
Intervention Description
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Intervention Type
Drug
Intervention Name(s)
Paxlovid
Other Intervention Name(s)
Nirmatrelvir / ritonavir
Intervention Description
Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days
Primary Outcome Measure Information:
Title
Time to sustained clinical recovery
Description
Time to sustained clinical recovery up to 28 days.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
AEs and SAEs through Day 28
Description
AEs and SAEs through Day 28
Time Frame
Up to 28 days
Title
Percentage of participants who experience these events by Day 28
Description
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
Time Frame
Day 1 to 28 days
Title
Percentage of clinical recovery participants
Description
Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Time Frame
Days 3, 5, 7, 10, 14, 21 and 28
Title
The change of COVID-19 symptom scores
Description
The change of "COVID-19 symptom scores" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.
Time Frame
Days 3, 5, 7, 10, 14, 21 and 28
Title
The change of WHO clinical progression scale
Description
The change of "WHO clinical progression scale" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 10 and higher scores mean a worse clinical progression.
Time Frame
Days 3, 5, 7, 10, 14, 21 and 28
Title
Percentage of participants with SARS-CoV-2 clearance
Description
Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14
Time Frame
Days 3, 5, 7, 10, 14
Title
The change of SARS-COV-2 Ct value
Description
The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14
Time Frame
Days 3, 5, 7, 10, 14
Title
The change of Chest CT scan
Description
The change of Chest CT scan from baseline to Days 7 or 10. The change from baseline involves not changed, getting worse, getting better as assessed by the investigator.
Time Frame
Days 7 or 10
Title
Percentage of the participants who have progression of COVID-19 though Day 28
Description
Progress to severe and/or critical COVID-19; Death from any cause
Time Frame
Up to 28 days
Title
Percentage of participants whose "WHO clinical progression scale" reduced at least one level
Description
Percentage of participants whose "WHO clinical progression scale" reduced at least one level from baseline to Days 3, 5, 7, 10, 14, 21 and 28. The score ranges from 0 to 10 and the higher scores mean a worse clinical progression level.
Time Frame
Days 3, 5, 7, 10, 14, 21 and 28
Title
Time to sustained clinical symptom resolution
Description
Time to sustained clinical symptom resolution
Time Frame
Up to 28 days
Title
Percentage of participants with clinical symptom resolution
Description
Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28
Time Frame
Days 3, 5, 7, 10, 14, 21 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ning
Organizational Affiliation
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Shanghai Tongren Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200093
Country
China
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
ShuGuang Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Facility Name
Shanghai Pudong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201399
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201900
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

We'll reach out to this number within 24 hrs