Clinical trial
Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial
Name
NCRC2023001
Description
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.
Trial arms
Trial start
2023-01-28
Estimated PCD
2023-03-24
Trial end
2026-01-06
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Arms:
NR group, combination group
Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
Arms:
UA group, combination group
Size
491
Primary endpoint
MACCE
30 days after surgery or during hospitalization
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 491, 'type': 'ACTUAL'}}
Updated at
2023-04-10
1 organization
1 product
1 drug
1 indication
Indication
Cardiac surgeryProduct
Ursodeoxycholic acid