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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NR group | Experimental | nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days |
|
| UA group | Experimental | ursodeoxycholic acid group, 15mg/kg/day bid for5 days |
|
| combination group | Experimental | nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days and ursodeoxycholic acid group, 15mg/kg/day bid for5 days |
|
| control group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirmatrelvir/ritonavir | Drug | nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia | 30 days after surgery or during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | 30 days after surgery or during hospitalization |
| Rate of Myocardial infarction | new onset of myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 10010 | China |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Ursodeoxycholic acid | Drug | ursodeoxycholic acid 15mg/kg/day bid for5 days |
|
| 30 days after surgery or during hospitalization |
| Rate of Stroke | new onset of stroke | 30 days after surgery or during hospitalization |
| Rate of Moderate to severe acute kidney injury | new onset of moderate to severe acute kidney injury | 30 days after surgery or during hospitalization |
| Rate of COVID-19 pneumonia | new onset of COVID-19 pneumonia | 30 days after surgery or during hospitalization |
| Rate of Cardiogenic death | Cardiogenic death | 30 days after surgery or during hospitalization |
| Rate of Severe pneumonia | new onset of Severe pneumonia | 30 days after surgery or during hospitalization |
| Rate of Ventilation ≥24h | Ventilation ≥24h after surgery | 30 days after surgery or during hospitalization |
| Rate of Pulmonary embolism | new onset of Pulmonary embolism | 30 days after surgery or during hospitalization |
| Rate of Re-operation for bleeding | Re-operation for bleeding after primary surgery | 30 days after surgery or during hospitalization |
| All-cause mortality | All-cause mortality | 1 year after surgery |
| Rate of Myocardial infarction | new onset of Myocardial infarction | 1 year after surgery |
| Rate of Stroke | new onset of Stroke | 1 year after surgery |
| Rate of Renal insufficiency | new onset of Renal insufficiency | 1 year after surgery |
| Rate of Re-hospitalization for respiratory disease | Re-hospitalization for respiratory disease | 1 year after surgery |
| Rate of Cardiogenic re-hospitalization | Cardiogenic re-hospitalization | 1 year after surgery |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |