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

NCT05242042 | Terminated Phase 2 DMC

• 1 other identifier: JT001-004-II/III-COVID-19
• Study Type: interventional
• Target: 381
• Locations: 2 countries
• Sites: 8

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.

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

• progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause

  1. Percentage of the participants who have progression of COVID-19 2. Time to sustained clinical symptom resolution

  Up to 28 days

Secondary Outcomes (8)

• Overall participant clinical status

  Up to 28 days

• COVID-19-related hospitalization rate of non-hospitalized participants

  Up to 28 days

• SARS-CoV-2 negative rate through Day7

  Baseline through Day 7

• The plasma concentration

  Baseline through Day 5

• Safety assessments

  Up to 28 days

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: JT001

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JT001 DRUG

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

Also known as: VV116

Arm 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of 18 years of age or older
• 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
• Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3
• Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization
• 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 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

You may not qualify if:

• 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, or heart rate ≥125 per minute
• Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
• 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
• Participants who have eye disease
• Participants who have ALT or AST\>2 ULN at screening
• 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) within 180 days prior to screening visit
• \. Participants who have received convalescent COVID-19 plasma treatment
• \. 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

Sponsors & Collaborators

• Shanghai JunTop Biosciences Co., LTD: lead
• Sponsor GmbH: collaborator

Study Sites (8)

Chongqing Public Health Medical Center

Chongqing, Chongqing Municipality, China

Location

Thesixth peoples Hospital Of ZhengZhou

Zhengzhou, Henan, China

Location

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

Location

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, China

Location

The Sixth People's Hospital of ShenYang

Shenyang, Liaoning, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

CUHK Medical Centre

Hong Kong, Hong Kong

Location

CUHK Phase 1 Clinical Trial Centre

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

GS-621763

Study Officials

• Juan Ma, Medical Director

  Shanghai JunTop Biosciences Co., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 16, 2022
• Study Start: January 28, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

HK (2); CN (6)