JT001 (VV116) for the Treatment of COVID-19
- Summary
- The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.
- Short title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-02-14
- First posted
- 2022-10-17
- Registry last updated
- 2023-06-28
- Primary completion date
- 2023-02-14
- Start date
- 2022-10-21
- Actual participants
- 1,369
- Participants
- 1,369
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05582629
- ClinicalTrials.gov ID
- NCT05582629
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
Timeframe: Up to 28 days
Time to sustained clinical symptoms resolution
Clinical alleviation
Timeframe: Up to 28 days
Time to sustained clinical symptoms alleviation
Disease progression
Timeframe: 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
SARS-CoV-2 nucleic acid and viral load
Timeframe: 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
Timeframe: Up to 28 days
Safety assessments such as AEs and SAEs through Day 28
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
Participants of 18 years of age or older, at the time of signing of informed consent.
-
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.
-
Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose.
-
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
-
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.
-
Understand and agree to comply with planned study procedures.
-
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.
- Fuzhou Pulmonary Hospital Of FujianFuzhou, China
- The third people's hospital of ShenzhenShenzhen, China
- Wuhan Infections Diseases HospitalWuhan, China
- The Fourth Hospital in Inner MongoliaHohhot, China
- The Sixth People's Hospital of ShenYangShenyang, China
- Shandong Public Health Clinical CenterJinan, China
- Shanghai Public Health Clinical CenterShanghai, China
- Shulan (Hangzhou) HospitalHangzhou, China
- Quzhou People's HospitalQuzhou, China
- PubMed 38006892Related publication
Related records
Drugs (1)
Collaborators (1)
- Sponsor GmbH
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition