COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05386433

Jieming QU

not reported

2022-05-23

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: sign informed consent. age ≥ 18 years old. covid-19 (nucleic acid test positive) was diagnosed before randomization. at least 1 symptom or sign of covid-19 at the time of being enrolled into the study(symptoms and signs related to covid-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).

history of active liver disease, including chronic or active hepatitis b or c, primary biliary cirrhosis, child-pugh b or c, or acute liver failure. hiv infection and the viral load is greater than 400 copies/ml. suspected or confirmed active systemic infections that may have an impact on the study evaluation except for covid-19. acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications. allergic to any ingredients of paxlovid.

2

Ruijin Hospital

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

40

Proportion of ICU transfer or disease progression to severe or critical illness;time of negative conversion of SARS-CoV-2 nucleic acid

None

Phase 1

[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]