NCT05690646

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After informed consent, four centers and 436 eligible admissions will be recruited. Eligible patients would be randomized (1:1:1:1) to nirmatrelvir/ritonavir group (nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days), ursodeoxycholic acid group (ursodeoxycholic acid group, 15mg/kg/day bid for5 days), combination group (nirmatrelvir/ritonavir and ursodeoxycholic acid for 5days) and control group.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-28
• Primary completion: 2023-03-24
• Completion: 2026-01-06
• First posted: 2023-01-19
• Last updated: 2023-04-10

Locations

1 site across 1 country: China