JT001 (VV116) for the Treatment of COVID-19

A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) in Participants With Mild to Moderate COVID-19

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate COVID-19
• Intervention / Treatment: Drug: JT001; Drug: Placebo

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 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

This is the general sequence of events during the 28-day treatment and assessment period:

Complete baseline procedures and samples collection； Participants are randomized to experimental arm or placebo arm； Participants receive study intervention (Q12H X 5 days)； Complete all safety monitoring； Complete all efficacy data collection； Blood samples collection

• Study Type: Interventional
• Enrollment (Actual): 1369
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fuzhou Pulmonary Hospital of Fujian
  • Guangdong
    • Shenzhen, Guangdong, China
      • The Third People's Hospital of Shenzhen
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Infections Diseases Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • The Fourth Hospital in Inner Mongolia
  • Liaoning
    • Shenyang, Liaoning, China
      • The Sixth People's Hospital of Shenyang
  • Shandong
    • Jinan, Shandong, China
      • Shandong Public Health Clinical Center
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Public Health Clinical Center
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Shulan (Hangzhou) Hospital
    • Quzhou, Zhejiang, China
      • Quzhou People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants of 18 years of age or older, at the time of signing of informed consent.

2. Have a positive SARS-CoV-2 test result, and sample collection for the first positive SARS-CoV-2 viral infection determination ≤5 days prior to the first dose.

   Note: PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.

3. Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.

4. Have any of the following targeted COVID-19-related symptoms with COVID-19 Related Symptoms score ≥2 within 24 hours before the first dose:

   fever

   cough

   sore throat

   stuffy or running nose,

   headache

   muscle or body aches

   shortness of breath or difficulty breathing

   nausea

   chills or shivering

   vomiting

   diarrhea

5. Agree to adhere to contraception restrictions.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Understand and agree to comply with planned study procedures.
7. 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. Severe or critical COVID-19.
2. SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300 (with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
3. Require mechanical ventilation or anticipated impending need for mechanical ventilation.
4. 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. Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion).
6. ALT or AST>2 ULN at screening.
7. 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. Received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 30 days prior to screening.
10. Received convalescent COVID-19 plasma treatment within 30 days prior to screening.
11. Participated in a clinical study involving an investigational intervention within the last 30 days. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
12. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
13. Female who are pregnant or breast-feeding or 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet	Drug: JT001; JT001 administered orally in tablet form every 12 hours for 5 days; Other Names: VV116
Placebo Comparator: Arm 2; Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet	Drug: Placebo; Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery	Time to sustained clinical symptoms resolution	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical alleviation	Time to sustained clinical symptoms alleviation	Up to 28 days
Disease progression	Percentage of participants who experience the following events of disease progression through Day 28 COVID-19-related hospitalization in non-hospitalized participants Progression to severe COVID-19 Progression to critical COVID-19 Death from any cause	Up to 28 days
SARS-CoV-2 nucleic acid and viral load	Percentage of participants who achieve SARS-CoV-2 negative through Days 5 and 7 Change of SARS-CoV-2 Ct Value from baseline to Days 5 and 7 Change of SARS-CoV-2 viral load from baseline to Days 5 and 7 SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7	Up to 28 days
Safety	Safety assessments such as AEs and SAEs through Day 28	Up to 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 viral genetic variation	To assess SARS-CoV-2 viral genetic variation	Day 1
SARS-CoV-2 negative	Time to SARS-CoV-2 negative	Up to 28 days

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Collaborators: Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• 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
• Other Study ID Numbers: JT001-015-III-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Complete de-identified patient data set

IPD Sharing Time Frame

With publication :

Access to all individual participant data collected during the trial, will be provided after anonymization with publication.No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents will be provided in a secure data sharing environment.

IPD Sharing Access Criteria

Upon request to the corresponding authors (ljli@zju.edu.cn). Qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses.

De-identified individual participant data and relevant clinical trial documents will be shared for the purpose of conducting legitimate research as specified in an approved formal research proposal.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No