COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05341609

Guang Ning

Not reported

2022-04-22

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: participants who have a positive sars-cov-2 test result. participants who have one or more mild or moderate covid-19 symptoms, and total symptom score ≥ 2. participants who have one or more of the following requirements: ≤7 days from the first positive test for sars-cov-2 virus infection to the first dose; ≤5 days from the first onset of covid-19 symptoms to the first dose; sars-cov-2 ct value ≤20 within 24 hours prior to the first dose. 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 or legally authorized representatives can give written informed consent approved by the ethical review board governing the site. 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.

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. participants who require mechanical ventilation or anticipated impending need for mechanical ventilation. participants who have eye disease. participants who have any of the following conditions when screening: alt or ast>1.5 uln; e gfr <60 ml/min. participants who have known allergies to any of the components used in the formulation of the interventions. any medical condition, which in the opinion of the investigator, will compromise the safety of the participant. participants who have received a sars-cov-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment). participants who have received convalescent covid-19 plasma treatment. participant's use of contraindicated drugs in the package insert of nirmatrelvir tablet/ritonavir tablets. 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. participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. female who is pregnant or breast-feeding or plan to be pregnant within this study period. male whose wife or partner plan to be pregnant within this study period.

2

Vigonvita Life Sciences

18

100

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

822

Time to sustained clinical recovery

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 2175, "treatment_name": "Vv116", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]