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

NCT ID: NCT05242042

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2023-03-23

Brief 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.

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

Conditions

Mild to Moderate COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

JT001

Intervention Type: DRUG

JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

JT001

JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

VV116

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sponsor GmbH

OTHER

Sponsor Role: collaborator

Shanghai JunTop Biosciences Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Ma, Medical Director

Role: STUDY_DIRECTOR

Shanghai JunTop Biosciences Co., LTD

Locations

Chongqing Public Health Medical Center

Chongqing, Chongqing Municipality, China

Thesixth peoples Hospital Of ZhengZhou

Zhengzhou, Henan, China

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, China

The Sixth People's Hospital of ShenYang

Shenyang, Liaoning, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

CUHK Medical Centre

Hong Kong, , Hong Kong

CUHK Phase 1 Clinical Trial Centre

Hong Kong, , Hong Kong

Countries

China; Hong Kong

Other Identifiers

JT001-004-II/III-COVID-19

Identifier Type: -

Identifier Source: org_study_id