JT001 (VV116) for the Treatment of COVID-19

NCT05582629 | Completed Phase 3 DMC

• 1 other identifier: JT001-015-III-COVID-19
• Study Type: interventional
• Target: 1,369
• Locations: 1 country
• Sites: 9

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.

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

• Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery

  Time to sustained clinical symptoms resolution

  Up to 28 days

Secondary Outcomes (4)

• Clinical alleviation

  Up to 28 days

• Disease progression

  Up to 28 days

• SARS-CoV-2 nucleic acid and viral load

  Up to 28 days

• Safety

  Up to 28 days

Other Outcomes (2)

• SARS-CoV-2 viral genetic variation

  Day 1

• SARS-CoV-2 negative

  Up to 28 days

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: JT001

Arm 2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JT001 DRUG

JT001 administered orally in tablet form every 12 hours for 5 days

Also known as: VV116

Arm 1

Placebo DRUG

Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (9)

Fuzhou Pulmonary Hospital Of Fujian

Fuzhou, Fujian, China

Location

The third people's hospital of Shenzhen

Shenzhen, Guangdong, China

Location

Wuhan Infections Diseases Hospital

Wuhan, Hubei, China

Location

The Fourth Hospital in Inner Mongolia

Hohhot, Inner Mongolia, China

Location

The Sixth People's Hospital of ShenYang

Shenyang, Liaoning, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310022, China

Location

Quzhou People's Hospital

Quzhou, Zhejiang, China

Location

Related Publications (1)

• Fan X, Dai X, Ling Y, Wu L, Tang L, Peng C, Huang C, Liu H, Lu H, Shen X, Zhang W, Wang F, Li G, Li M, Huang Y, Zhang H, Li M, Ren F, Li Y, Liu C, Zhou Z, Sun W, Yi Y, Zhou D, Gao H, Pan Q, Liu H, Zhao J, Ding Z, Ma Y, Li W, Wang Q, Wang X, Bai Y, Jiang X, Ma J, Xie B, Zhang K, Li L. Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. Lancet Infect Dis. 2024 Feb;24(2):129-139. doi: 10.1016/S1473-3099(23)00577-7. Epub 2023 Nov 22.

  PMID: 38006892 DERIVED

MeSH Terms

Interventions

GS-621763

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: October 21, 2022
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: With publication : Access to all individual participant data collected during the trial, will be provided after anonymization with publication.No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents will be provided in a secure data sharing environment.
• Access Criteria: Upon request to the corresponding authors (ljli@zju.edu.cn). Qualified science and medical researchers upon formal request and submission of research proposal detailing planned analyses. De-identified individual participant data and relevant clinical trial documents will be shared for the purpose of conducting legitimate research as specified in an approved formal research proposal.

Locations

CN (9)