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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
491
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
ursodeoxycholic acid 15mg/kg/day bid for5 days
Fuwai Hospital
Beijing, Beijing Municipality, China
MACCE
All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia
Time frame: 30 days after surgery or during hospitalization
All-cause mortality
All-cause mortality
Time frame: 30 days after surgery or during hospitalization
Rate of Myocardial infarction
new onset of myocardial infarction
Time frame: 30 days after surgery or during hospitalization
Rate of Stroke
new onset of stroke
Time frame: 30 days after surgery or during hospitalization
Rate of Moderate to severe acute kidney injury
new onset of moderate to severe acute kidney injury
Time frame: 30 days after surgery or during hospitalization
Rate of COVID-19 pneumonia
new onset of COVID-19 pneumonia
Time frame: 30 days after surgery or during hospitalization
Rate of Cardiogenic death
Cardiogenic death
Time frame: 30 days after surgery or during hospitalization
Rate of Severe pneumonia
new onset of Severe pneumonia
Time frame: 30 days after surgery or during hospitalization
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Rate of Ventilation ≥24h
Ventilation ≥24h after surgery
Time frame: 30 days after surgery or during hospitalization
Rate of Pulmonary embolism
new onset of Pulmonary embolism
Time frame: 30 days after surgery or during hospitalization
Rate of Re-operation for bleeding
Re-operation for bleeding after primary surgery
Time frame: 30 days after surgery or during hospitalization
All-cause mortality
All-cause mortality
Time frame: 1 year after surgery
Rate of Myocardial infarction
new onset of Myocardial infarction
Time frame: 1 year after surgery
Rate of Stroke
new onset of Stroke
Time frame: 1 year after surgery
Rate of Renal insufficiency
new onset of Renal insufficiency
Time frame: 1 year after surgery
Rate of Re-hospitalization for respiratory disease
Re-hospitalization for respiratory disease
Time frame: 1 year after surgery
Rate of Cardiogenic re-hospitalization
Cardiogenic re-hospitalization
Time frame: 1 year after surgery