JT001 (VV116) for the Treatment of COVID-19
- Registration Number
- NCT05582629
- Lead Sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1369
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Participants of 18 years of age or older, at the time of signing of informed consent.
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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.
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Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.
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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
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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.
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Understand and agree to comply with planned study procedures.
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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.
- Severe or critical COVID-19.
- 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.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- 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.
- Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion).
- ALT or AST>2 ULN at screening.
- 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.
- Received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 30 days prior to screening.
- Received convalescent COVID-19 plasma treatment within 30 days prior to screening.
- 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.
- Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Female who are pregnant or breast-feeding or plan to be pregnant within this study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet Arm 1 JT001 JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet
- Primary Outcome Measures
Name Time Method Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery Up to 28 days Time to sustained clinical symptoms resolution
- Secondary Outcome Measures
Name Time Method Clinical alleviation Up to 28 days Time to sustained clinical symptoms alleviation
SARS-CoV-2 nucleic acid and viral load Up to 28 days Percentage of participants who achieve SARS-CoV-2 negative through Days 5 and 7 Change of SARS-CoV-2 Ct Value from baseline to Days 5 and 7 Change of SARS-CoV-2 viral load from baseline to Days 5 and 7 SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7
Safety Up to 28 days Safety assessments such as AEs and SAEs through Day 28
Disease progression Up to 28 days Percentage of participants who experience the following events of disease progression through Day 28 COVID-19-related hospitalization in non-hospitalized participants Progression to severe COVID-19 Progression to critical COVID-19 Death from any cause
Trial Locations
- Locations (9)
The third people's hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Fuzhou Pulmonary Hospital Of Fujian
🇨🇳Fuzhou, Fujian, China
Wuhan Infections Diseases Hospital
🇨🇳Wuhan, Hubei, China
The Sixth People's Hospital of ShenYang
🇨🇳Shenyang, Liaoning, China
The Fourth Hospital in Inner Mongolia
🇨🇳Hohhot, Inner Mongolia, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China
Shandong Public Health Clinical Center
🇨🇳Jinan, Shandong, China
Shulan (Hangzhou) Hospital
🇨🇳Hangzhou, Zhejiang, China
Quzhou People's Hospital
🇨🇳Quzhou, Zhejiang, China