COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05242042

Jie Wang, Project Manager

jie_wang5@junshipharma.com

2022-02-16

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: participants of 18 years of age or older participants who have a positive sars-cov-2 test result, and have sample collection for first positive sars-cov-2 viral infection determination ≤5 days prior to randomization participants who have one or more mild or moderate covid-19 symptoms as follows and have a covid-19 related symptom score ≥3 participants with the onset of symptoms of covid-19 ≤5 days prior to randomization participants who satisfy one or more than one of the following high risks for progression to severe covid-19, including death: participants who must agree to adhere to contraception restrictions participants who understand and agree to comply with planned study procedures participants 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

participants who are judged by the investigator as likely to progress to severe/critical covid-19 prior to randomization. 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 participants who require mechanical ventilation or anticipated impending need for mechanical ventilation 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 participants who have eye disease participants who have alt or ast>2 uln at screening 7 participants who have known 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. participants who have received a sars-cov-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 180 days prior to screening visit 10. participants who have received convalescent covid-19 plasma treatment 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

2

Shanghai JunTop Biosciences Co., LTD

18

100

China;Hong Kong

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1310

progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 2175, "treatment_name": "Vv116", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]