JT001 (VV116) for the Early Treatment of COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai JunTop Biosciences Co., LTD
• Collaborator: Sponsor GmbH

Criteria

Inclusion Criteria:

1. Participants who have a positive SARS-CoV-2 test result

2. Participants who have one or more mild or moderate COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion

3. Participants who have sample collection for first positive SARS-CoV-2 viral infection determination and the onset of symptoms of COVID-19 ≤5 days prior to randomization

4. Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death:

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 as described in Appendix 1 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 severe/critical COVID-19 prior to randomization.

2. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute, or heart rate ≥125 per minute

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

4. 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

5. Participants who have eye disease

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 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

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

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

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