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

Mild to Moderate COVID-19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05242042
• Other study ID #: JT001-004-II/III-COVID-19
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 28, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: September 2023
• Source: Shanghai JunTop Biosciences Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 381
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mild to Moderate COVID-19

Intervention

Drug:
• JT001
JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)
• Placebo
Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai JunTop Biosciences Co., LTD	Sponsor GmbH

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The plasma concentration	The plasma concentration of JT001 (VV116) and major metabolites	Baseline through Day 5
Secondary	Safety assessments	Safety assessments such as AEs and SAEs	Up to 28 days
Secondary	SARS-CoV-2 viral load	The SARS-CoV-2 viral load change from baseline to Day 5 and 7	Baseline through Day 7
Secondary	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
Secondary	To assess SARS-CoV-2 viral genetic variation	SARS-CoV-2 viral genetic variation	Day 1