Clinical trial NCT05279235: Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Official title: A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Moderate to Severe COVID-19
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sponsor GmbH
First posted: 2022-03-15
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

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

Eligibility criteria: 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

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

Primary outcomes:
measure: progression of COVID-19
timeFrame: Up to 29 days
Secondary outcomes:
measure: AEs and SAEs
timeFrame: Up to 29 days
measure: Progress, Death
timeFrame: Up to 29 days
measure: WHO 11-point ordinal outcome scale
timeFrame: Day 3, 5, 7, 10 and 29
measure: The change of Chest CT scan
timeFrame: Day 7 and 10
measure: SARS-CoV-2 clearance
timeFrame: Day 3, 5 ,7 and 10
Other outcomes:
measure: SARS-CoV-2 viral genetic variation
timeFrame: Day 1
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Tashkent
country: Uzbekistan
facility: Specialized lnfectious Diseases Hospital No2 of Zangiota District
state: Tashkent Province
Study officials:
affiliation: Shanghai Junshi Bioscience Co., Ltd.
name: Juan Ma, Master
role: STUDY_DIRECTOR
References: