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

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.

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.

Study Overview

• Status: Terminated
• 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, 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

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jie Wang, Project Manager; Phone Number: 8618036618073; Email: jie_wang5@junshipharma.com
• Study Contact Backup: Name: Yali Pan, Project Directer; Phone Number: 8618621590299; Email: yali_pan@junshipharma.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Chongqing Public Health Medical Center
  • Henan
    • Zhengzhou, Henan, China
      • Thesixth peoples Hospital Of ZhengZhou
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi No.5 People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Ninth Hospital of Nanchang
  • Liaoning
    • Shenyang, Liaoning, China
      • The Sixth People's Hospital of Shenyang
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center
• Hong Kong
  • Hongkong, Hong Kong
    • CUHK Medical Centre
  • Hongkong, Hong Kong
    • CUHK Phase 1 Clinical Trial Centre

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
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

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	Drug: JT001; JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total); Other Names: VV116
Placebo Comparator: Arm 2	Drug: Placebo; Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 28 days
COVID-19-related hospitalization rate of non-hospitalized participants	Percentage of participants who experience COVID-19-related hospitalization by Day 28	Up to 28 days
SARS-CoV-2 negative rate through Day7	Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7	Baseline through Day 7
The plasma concentration	The plasma concentration of JT001 (VV116) and major metabolites	Baseline through Day 5
Safety assessments	Safety assessments such as AEs and SAEs	Up to 28 days
SARS-CoV-2 viral load	The SARS-CoV-2 viral load change from baseline to Day 5 and 7	Baseline through Day 7
SARS-CoV-2 viral load	SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7	Baseline through Day 7
To assess SARS-CoV-2 viral genetic variation	SARS-CoV-2 viral genetic variation	Day 1

Collaborators and Investigators

• Sponsor: Shanghai JunTop Biosciences Co., LTD
• Collaborators: Sponsor GmbH
• Investigators: Study Director: Juan Ma, Medical Director, Shanghai JunTop Biosciences Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 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: JT001-004-II/III-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

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