Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

Phase 3

Terminated

• Conditions: Moderate to Severe COVID-19
• Interventions: Drug: JT001; Drug: JT001 placebo; Drug: Favipiravir placebo; Drug: Favipiravir

• Registration Number: NCT05279235
• Lead Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe 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, risk factors 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 Period

This is the general sequence of events during the 29-day treatment and assessment period:

* Complete baseline procedures and sample collection

* Participants are randomized to an intervention group

* Participants receive study intervention (Q12H X 5 days), and

* Complete all safety monitoring.

* Blood samples collection

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-03-08
• Study Start: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-15
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Participants of 18 years of age or older, at the time of signing of informed consent
2. Participants who have a positive SARS-CoV-2 test result
3. Participants who have one or more COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
4. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
5. Participants who must agree to adhere to contraception restrictions
6. Participants who understand and agree to comply with planned study procedures
7. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Read More

Exclusion Criteria

1. Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.

2. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation

3. Participants who 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

4. Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)

5. Participants who have any of the following conditions when screening:

   • ALT or AST>1.5 ULN
   • Systolic blood pressure < 90 mm Hg
   • Diastolic blood pressure < 60 mm Hg
   • Requiring vasopressors
   • Multi-organ dysfunction/failure

6. Participants who have known allergies to any of the components used in the formulation of the interventions

7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant

8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)

9. Participants who have received convalescent COVID-19 plasma treatment

10. Participants who have received SARS-CoV-2 vaccine prior to randomization.

11. Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed

12. Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period

14. Male whose wife or partner plan to be pregnant within this study period

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JT001& Favipiravir Placebo	Favipiravir placebo	JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
JT001& Favipiravir Placebo	JT001	JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Favipiravir & JT001 Placebo	JT001 placebo	Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Favipiravir & JT001 Placebo	Favipiravir	Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days

Primary Outcome Measures

Name	Time	Method
progression of COVID-19	Up to 29 days	Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19\* or death from any cause, through Day 29

Secondary Outcome Measures

Name	Time	Method
AEs and SAEs	Up to 29 days	Safety assessments such as AEs and SAEs through Day 29
WHO 11-point ordinal outcome scale	Day 3, 5, 7, 10 and 29	The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
SARS-CoV-2 clearance	Day 3, 5 ,7 and 10	Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Progress, Death	Up to 29 days	Percentage of participants who experience these events by Day 29; * Progress to critical COVID-19; * Death from any cause
The change of Chest CT scan	Day 7 and 10	The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）

Trial Locations

Locations (2)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China

Specialized lnfectious Diseases Hospital No2 of Zangiota District; 🇺🇿 Tashkent, Tashkent Province, Uzbekistan