Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery
NCT05690646 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 491
Last updated 2023-04-10
Summary
Prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. The aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.
Conditions
- Cardiac Surgery
Interventions
- DRUG
-
Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
- DRUG
-
Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
Sponsors & Collaborators
-
China National Center for Cardiovascular Diseases
lead OTHER_GOV
Principal Investigators
-
Shengshou Hu · Chinese Academy of Medical Sciences, Fuwai Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-28
- Primary Completion
- 2023-03-24
- Completion
- 2026-01-06
Countries
- China
Study Locations
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