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

National Center for Cardiovascular Diseases

Status and phase: Active, not recruiting; Phase 4

Conditions: Cardiac Surgery

Treatments: Drug: Ursodeoxycholic acid; Drug: Nirmatrelvir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT05690646

NCRC2023001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 491 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• COVID-19 nucleic acid test or antigen test positive history, without symptom or recover from COVID-19 related symptoms ≥2 weeks
• Receive open-chest cardiac surgery
• COVID-19 nucleic acid test and antigen test negative and no signs of pneumonia in chest CT
• Patients with written informed consent.

Exclusion criteria

• Emergency surgery
• eGFR ≤30ml/min
• Severe liver dysfunction
• Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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491 participants in 4 patient groups

NR group

Experimental group

Description:

nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days

Treatment:

Drug: Nirmatrelvir/ritonavir

UA group

Experimental group

Description:

ursodeoxycholic acid group, 15mg/kg/day bid for5 days

Treatment:

Drug: Ursodeoxycholic acid

combination group

Experimental group

Description:

nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days and ursodeoxycholic acid group, 15mg/kg/day bid for5 days

Treatment:

Drug: Ursodeoxycholic acid

Drug: Nirmatrelvir/ritonavir

control group

No Intervention group

Description:

No intervention