Clinical trial NCT05582629: JT001 (VV116) for the Treatment of COVID-19
Official title: A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) in Participants With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild to Moderate COVID-19
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sponsor GmbH
First posted: 2022-10-17
Enrollment: 1369
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) 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 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

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

Complete baseline procedures and samples collection； Participants are randomized to experimental arm or placebo arm； 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, at the time of signing of informed consent.
2. Have a positive SARS-CoV-2 test result, and sample collection for the first positive SARS-CoV-2 viral infection determination ≤5 days prior to the first dose.

   Note: PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
3. Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.
4. Have any of the following targeted COVID-19-related symptoms with COVID-19 Related Symptoms score ≥2 within 24 hours before the first dose:

   fever

   cough

   sore throat

   stuffy or running nose,

   headache

   muscle or body aches

   shortness of breath or difficulty breathing

   nausea

   chills or shivering

   vomiting

   diarrhea
5. Agree to adhere to contraception restrictions.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Understand and agree to comply with planned study procedures.
7. 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. Severe or critical COVID-19.
2. SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300 (with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
3. Require mechanical ventilation or anticipated impending need for mechanical ventilation.
4. 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. Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion).
6. ALT or AST\>2 ULN at screening.
7. 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. Received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 30 days prior to screening.
10. Received convalescent COVID-19 plasma treatment within 30 days prior to screening.
11. Participated in a clinical study involving an investigational intervention within the last 30 days. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
12. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
13. Female who are pregnant or breast-feeding or plan to be pregnant within this study period.

Primary outcomes:
measure: Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
timeFrame: Up to 28 days
Secondary outcomes:
measure: Clinical alleviation
timeFrame: Up to 28 days
measure: Disease progression
timeFrame: Up to 28 days
measure: SARS-CoV-2 nucleic acid and viral load
timeFrame: Up to 28 days
measure: Safety
timeFrame: Up to 28 days
Other outcomes:
measure: SARS-CoV-2 viral genetic variation
timeFrame: Day 1
measure: SARS-CoV-2 negative
timeFrame: Up to 28 days
Locations:
city: Fuzhou
country: China
facility: Fuzhou Pulmonary Hospital Of Fujian
state: Fujian
city: Shenzhen
country: China
facility: The third people's hospital of Shenzhen
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Infections Diseases Hospital
state: Hubei
city: Hohhot
country: China
facility: The Fourth Hospital in Inner Mongolia
state: Inner Mongolia
city: Shenyang
country: China
facility: The Sixth People's Hospital of ShenYang
state: Liaoning
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Hangzhou
country: China
facility: Shulan (Hangzhou) Hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
Study officials:
References: