Clinical trial NCT05242042: JT001 (VV116) for the Early Treatment of COVID-19
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Mild to Moderate COVID-19
Lead sponsor: Shanghai JunTop Biosciences Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Sponsor GmbH
First posted: 2022-02-16
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
timeFrame: Up to 28 days
Secondary outcomes:
measure: Overall participant clinical status
timeFrame: Up to 28 days
measure: COVID-19-related hospitalization rate of non-hospitalized participants
timeFrame: Up to 28 days
measure: SARS-CoV-2 negative rate through Day7
timeFrame: Baseline through Day 7
measure: The plasma concentration
timeFrame: Baseline through Day 5
measure: Safety assessments
timeFrame: Up to 28 days
measure: SARS-CoV-2 viral load
timeFrame: Baseline through Day 7
measure: SARS-CoV-2 viral load
timeFrame: Baseline through Day 7
measure: To assess SARS-CoV-2 viral genetic variation
timeFrame: Day 1
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Public Health Medical Center
state: Chongqing
city: Zhengzhou
country: China
facility: Thesixth peoples Hospital Of ZhengZhou
state: Henan
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Ninth Hospital of Nanchang
state: Jiangxi
city: Shenyang
country: China
facility: The Sixth People's Hospital of ShenYang
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Hongkong
country: Hong Kong
facility: CUHK Medical Centre
city: Hongkong
country: Hong Kong
facility: CUHK Phase 1 Clinical Trial Centre
Study officials:
affiliation: Shanghai JunTop Biosciences Co., LTD
name: Juan Ma, Medical Director
role: STUDY_DIRECTOR
References: