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

CompletedPhase 4

Sponsor: China National Center for Cardiovascular Diseases

Conditions: Cardiac Surgery

Interventions: Nirmatrelvir/ritonavir, Ursodeoxycholic acid

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria At least 18 years old Undergoing open-chest cardiac surgery With a history of SARS-CoV-2 infection Absence of respiratory infection-related symptoms or without the symptoms for more than 2 weeks Negative COVID-19 nucleic acid test result and without any sign of viral pneumonia based on a chest computed tomography (CT) scan on the day of randomization Exclusion criteria Emergent/urgent surgery, i.e., heart transplantation, surgeries for acute aortic dissection, et. al.

Renal insufficiency with estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m2 Severe liver injury (Class C of Child-Pugh classification) Known allergy, intolerance, or contraindications to nirmatrelvir/ritonavir or ursodeoxycholic acid Having taken the following medications within the last 5 days (consideration for enrollment may be given if the patient's condition allows for a 5-day discontinuation period): alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, neratinib, venetoclax, amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine, fusidic acid, voriconazole, astemizole, tefenadine, colchicine, rifabutin, rifampicin, lurasidone, clozapine, pimozide, quetiapine, ergot derivatives, cisapride, clorazepate, lovastatin, simvastatin, lomitapide, avanafil, sildenafil, vardenafil, diazepam, sulazepam, flurazepam, midazolam triazolam, carbamazepine, phenobarbital, and phenytoin

Locations (1)

Beijing, Beijing Municipality, China