Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

• Status: Not yet recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Collaborator: Sponsor GmbH
• Treatments: Favipiravir

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