Clinical trial NCT05690646: Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery
Official title: Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Cardiac Surgery
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-01-19
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: MACCE
timeFrame: 30 days after surgery or during hospitalization
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Myocardial infarction
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Stroke
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Moderate to severe acute kidney injury
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of COVID-19 pneumonia
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Cardiogenic death
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Severe pneumonia
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Ventilation ≥24h
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Pulmonary embolism
timeFrame: 30 days after surgery or during hospitalization
measure: Rate of Re-operation for bleeding
timeFrame: 30 days after surgery or during hospitalization
measure: All-cause mortality
timeFrame: 1 year after surgery
measure: Rate of Myocardial infarction
timeFrame: 1 year after surgery
measure: Rate of Stroke
timeFrame: 1 year after surgery
measure: Rate of Renal insufficiency
timeFrame: 1 year after surgery
measure: Rate of Re-hospitalization for respiratory disease
timeFrame: 1 year after surgery
measure: Rate of Cardiogenic re-hospitalization
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shengshou Hu
role: PRINCIPAL_INVESTIGATOR
References: