JT001 (VV116) for the Treatment of COVID-19

Mild to Moderate COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582629
• Other study ID #: JT001-015-III-COVID-19
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: June 2023
• Source: Shanghai Vinnerna Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1369
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mild to Moderate COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Fuzhou Pulmonary Hospital Of Fujian	Fuzhou	Fujian
China	Shulan (Hangzhou) Hospital	Hangzhou	Zhejiang
China	The Fourth Hospital in Inner Mongolia	Hohhot	Inner Mongolia
China	Shandong Public Health Clinical Center	Jinan	Shandong
China	Quzhou People's Hospital	Quzhou	Zhejiang
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The Sixth People's Hospital of ShenYang	Shenyang	Liaoning
China	The third people's hospital of Shenzhen	Shenzhen	Guangdong
China	Wuhan Infections Diseases Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Vinnerna Biosciences Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SARS-CoV-2 viral genetic variation	To assess SARS-CoV-2 viral genetic variation	Day 1
Other	SARS-CoV-2 negative	Time to SARS-CoV-2 negative	Up to 28 days
Primary	Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery	Time to sustained clinical symptoms resolution	Up to 28 days
Secondary	Clinical alleviation	Time to sustained clinical symptoms alleviation	Up to 28 days
Secondary	Disease progression	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	Up to 28 days
Secondary	SARS-CoV-2 nucleic acid and viral load	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	Up to 28 days
Secondary	Safety	Safety assessments such as AEs and SAEs through Day 28	Up to 28 days