Clinical trial NCT05341609: Efficacy and Safety of JT001 (VV116) Compared With Paxlovid
Official title: A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: JT001(VV116)
Mild to Moderate COVID-19
Lead sponsor: Vigonvita Life Sciences
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 822
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 and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.

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.

Treatment and Assessment Period

This is the general sequence of events during the 28-day treatment and assessment period:

Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring

Eligibility criteria: Inclusion Criteria:

* Participants who have a positive SARS-CoV-2 test result.
* Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score ≥ 2.
* Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to the first dose; ≤5 days from the first onset of COVID-19 symptoms to the first dose; SARS-CoV-2 Ct Value ≤20 within 24 hours prior to the first dose.
* 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 or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
* Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* 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.
* Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
* Participants who have eye disease.
* Participants who have any of the following conditions when screening: ALT or AST\>1.5 ULN; e GFR \<60 mL/min.
* 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).
* Participants who have received convalescent COVID-19 plasma treatment.
* Participant's use of contraindicated drugs in the Package Insert of Nirmatrelvir Tablet/Ritonavir Tablets.
* 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.
* Male whose wife or partner plan to be pregnant within this study period.

Primary outcomes:
measure: Time to sustained clinical recovery
timeFrame: Up to 28 days
Secondary outcomes:
measure: AEs and SAEs through Day 28
timeFrame: Up to 28 days
measure: Percentage of participants who experience these events by Day 28
timeFrame: Day 1 to 28 days
measure: Percentage of clinical recovery participants
timeFrame: Days 3, 5, 7, 10, 14, 21 and 28
measure: The change of COVID-19 symptom scores
timeFrame: Days 3, 5, 7, 10, 14, 21 and 28
measure: The change of WHO clinical progression scale
timeFrame: Days 3, 5, 7, 10, 14, 21 and 28
measure: Percentage of participants with SARS-CoV-2 clearance
timeFrame: Days 3, 5, 7, 10, 14
measure: The change of SARS-COV-2 Ct value
timeFrame: Days 3, 5, 7, 10, 14
measure: The change of Chest CT scan
timeFrame: Days 7 or 10
measure: Percentage of the participants who have progression of COVID-19 though Day 28
timeFrame: Up to 28 days
measure: Percentage of participants whose "WHO clinical progression scale" reduced at least one level
timeFrame: Days 3, 5, 7, 10, 14, 21 and 28
measure: Time to sustained clinical symptom resolution
timeFrame: Up to 28 days
measure: Percentage of participants with clinical symptom resolution
timeFrame: Days 3, 5, 7, 10, 14, 21 and 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: ShuGuang Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Guang Ning
role: PRINCIPAL_INVESTIGATOR
References: