JT001 (VV116) for the Treatment of COVID-19

Shanghai Vinnerna Biosciences

Status and phase: Completed; Phase 3

Conditions: Mild to Moderate COVID-19

Treatments: Drug: Placebo; Drug: JT001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05582629

JT001-015-III-COVID-19

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.

Full 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

Enrollment: 1,369 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,369 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet

Treatment:

Drug: JT001

Arm 2

Placebo Comparator group

Description:

Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet

Treatment:

Drug: Placebo