Efficacy and Safety of JT001 (VV116) Compared With Paxlovid

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: JT001; Drug: Paxlovid

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 Type: Interventional
• Enrollment (Actual): 822
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200093
      • Shanghai Public Health Clinical Center
    • Shanghai, Shanghai, China, 200020
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200050
      • Shanghai Tongren Hospital
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 201203
      • ShuGuang Hospital
    • Shanghai, Shanghai, China, 201399
      • Shanghai Pudong Hospital
    • Shanghai, Shanghai, China, 201900
      • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Nirmatrelvir / ritonavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sustained clinical recovery	Time to sustained clinical recovery up to 28 days.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs and SAEs through Day 28	AEs and SAEs through Day 28	Up to 28 days
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	Day 1 to 28 days
Percentage of clinical recovery participants	Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28	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.	Days 3, 5, 7, 10, 14, 21 and 28
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.	Days 3, 5, 7, 10, 14, 21 and 28
Percentage of participants with SARS-CoV-2 clearance	Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14	Days 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value	The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14	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.	Days 7 or 10
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	Up to 28 days
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.	Days 3, 5, 7, 10, 14, 21 and 28
Time to sustained clinical symptom resolution	Time to sustained clinical symptom resolution	Up to 28 days
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	Days 3, 5, 7, 10, 14, 21 and 28

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Guang Ning, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 16, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: JT001(VV116); Mild to Moderate COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: JT001-010-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No