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

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05690646

Collaborator

(none)

436

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Drug: Nirmatrelvir/ritonavir Drug: Ursodeoxycholic acid	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

436 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Jan 6, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NR group nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days	Drug: Nirmatrelvir/ritonavir nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Experimental: UA group ursodeoxycholic acid group, 15mg/kg/day bid for5 days	Drug: Ursodeoxycholic acid ursodeoxycholic acid 15mg/kg/day bid for5 days
Experimental: combination group nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days and ursodeoxycholic acid group, 15mg/kg/day bid for5 days	Drug: Nirmatrelvir/ritonavir nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days Drug: Ursodeoxycholic acid ursodeoxycholic acid 15mg/kg/day bid for5 days
No Intervention: control group No intervention

Outcome Measures

Primary Outcome Measures

MACCE [30 days after surgery or during hospitalization]
All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia

Secondary Outcome Measures

All-cause mortality [30 days after surgery or during hospitalization]
All-cause mortality
Rate of Myocardial infarction [30 days after surgery or during hospitalization]
new onset of myocardial infarction
Rate of Stroke [30 days after surgery or during hospitalization]
new onset of stroke
Rate of Moderate to severe acute kidney injury [30 days after surgery or during hospitalization]
new onset of moderate to severe acute kidney injury
Rate of COVID-19 pneumonia [30 days after surgery or during hospitalization]
new onset of COVID-19 pneumonia
Rate of Cardiogenic death [30 days after surgery or during hospitalization]
Cardiogenic death
Rate of Severe pneumonia [30 days after surgery or during hospitalization]
new onset of Severe pneumonia
Rate of Ventilation ≥24h [30 days after surgery or during hospitalization]
Ventilation ≥24h after surgery
Rate of Pulmonary embolism [30 days after surgery or during hospitalization]
new onset of Pulmonary embolism
Rate of Re-operation for bleeding [30 days after surgery or during hospitalization]
Re-operation for bleeding after primary surgery
All-cause mortality [1 year after surgery]
All-cause mortality
Rate of Myocardial infarction [1 year after surgery]
new onset of Myocardial infarction
Rate of Stroke [1 year after surgery]
new onset of Stroke
Rate of Renal insufficiency [1 year after surgery]
new onset of Renal insufficiency
Rate of Re-hospitalization for respiratory disease [1 year after surgery]
Re-hospitalization for respiratory disease
Rate of Cardiogenic re-hospitalization [1 year after surgery]
Cardiogenic re-hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China	10010

Sponsors and Collaborators

China National Center for Cardiovascular Diseases

Investigators

Principal Investigator: Shengshou Hu, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

China National Center for Cardiovascular Diseases

ClinicalTrials.gov Identifier:

NCT05690646

Other Study ID Numbers:

NCRC2023001

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ritonavir

Ursodeoxycholic Acid

Study Results

No Results Posted as of Jan 19, 2023