Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

• ClinicalTrials.gov Identifier: NCT05341609
• Recruitment Status: Completed
• First Posted: April 22, 2022
• Last Update Posted: September 21, 2022
• Sponsor: Vigonvita Life Sciences
• Information provided by (Responsible Party): Vigonvita Life Sciences

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: JT001; Drug: Paxlovid	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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 822 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 4, 2022
• Actual Primary Completion Date: May 13, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: JT001(VV116); Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days	Drug: JT001; Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days; Other Name: VV116
Active Comparator: Paxlovid; Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days	Drug: Paxlovid; Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days; Other Name: Nirmatrelvir / ritonavir

Outcome Measures

Primary Outcome Measures :

1. Time to sustained clinical recovery [ Time Frame: Up to 28 days ]
   Time to sustained clinical recovery up to 28 days.

Secondary Outcome Measures :

1. AEs and SAEs through Day 28 [ Time Frame: Up to 28 days ]
   AEs and SAEs through Day 28
2. Percentage of participants who experience these events by Day 28 [ Time Frame: Day 1 to 28 days ]

   Percentage of participants who experience these events by Day 28

   Progress to severe and/or critical COVID-19; Death from any cause

3. Percentage of clinical recovery participants [ Time Frame: Days 3, 5, 7, 10, 14, 21 and 28 ]
   Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28
4. The change of COVID-19 symptom scores [ Time Frame: Days 3, 5, 7, 10, 14, 21 and 28 ]
   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.
5. The change of WHO clinical progression scale [ Time Frame: Days 3, 5, 7, 10, 14, 21 and 28 ]
   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.
6. Percentage of participants with SARS-CoV-2 clearance [ Time Frame: Days 3, 5, 7, 10, 14 ]
   Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14
7. The change of SARS-COV-2 Ct value [ Time Frame: Days 3, 5, 7, 10, 14 ]
   The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14
8. The change of Chest CT scan [ Time Frame: Days 7 or 10 ]
   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.
9. Percentage of the participants who have progression of COVID-19 though Day 28 [ Time Frame: Up to 28 days ]
   Progress to severe and/or critical COVID-19; Death from any cause
10. Percentage of participants whose "WHO clinical progression scale" reduced at least one level [ Time Frame: Days 3, 5, 7, 10, 14, 21 and 28 ]
    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.
11. Time to sustained clinical symptom resolution [ Time Frame: Up to 28 days ]
    Time to sustained clinical symptom resolution
12. Percentage of participants with clinical symptom resolution [ Time Frame: Days 3, 5, 7, 10, 14, 21 and 28 ]
    Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China, Shanghai

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, 200020

Shanghai Tongren Hospital

Shanghai, Shanghai, China, 200050

Shanghai Public Health Clinical Center

Shanghai, Shanghai, China, 200093

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, 200127

ShuGuang Hospital

Shanghai, Shanghai, China, 201203

Shanghai Pudong Hospital

Shanghai, Shanghai, China, 201399

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai, China, 201900

Sponsors and Collaborators

Vigonvita Life Sciences

Investigators

• Principal Investigator: Guang Ning; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

More Information

• Responsible Party: Vigonvita Life Sciences
• ClinicalTrials.gov Identifier: NCT05341609
• Other Study ID Numbers: JT001-010-COVID-19
• First Posted: April 22, 2022
• Last Update Posted: September 21, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vigonvita Life Sciences:

JT001(VV116); Mild to Moderate COVID-19

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ritonavir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors