Cardiac SurgeryPhase 4PEPNCT05690646
Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery
A Phase 4 study testing Nirmatrelvir/ritonavir and Ursodeoxycholic acid in people with Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Nirmatrelvir/ritonavir and Ursodeoxycholic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2023to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Nirmatrelvir/ritonavir, Ursodeoxycholic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/ritonavirDrug
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Ursodeoxycholic acidDrug
ursodeoxycholic acid 15mg/kg/day bid for5 days
| Study group | Role | What they receive |
|---|---|---|
| NR group | Experimental | nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days Receives: Drug: Nirmatrelvir/ritonavir |
| UA group | Experimental | ursodeoxycholic acid group, 15mg/kg/day bid for5 days Receives: Drug: Ursodeoxycholic acid |
| combination group | Experimental | nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days and ursodeoxycholic acid group, 15mg/kg/day bid for5 days Receives: Drug: Nirmatrelvir/ritonavir; Drug: Ursodeoxycholic acid |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia
Measured: 30 days after surgery or during hospitalization
Secondary outcomes (16)
All-cause mortality
All-cause mortality
Measured: 30 days after surgery or during hospitalization
Rate of Myocardial infarction
new onset of myocardial infarction
Measured: 30 days after surgery or during hospitalization
Rate of Stroke
new onset of stroke
Measured: 30 days after surgery or during hospitalization
Rate of Moderate to severe acute kidney injury
new onset of moderate to severe acute kidney injury
Measured: 30 days after surgery or during hospitalization
Rate of COVID-19 pneumonia
new onset of COVID-19 pneumonia
Measured: 30 days after surgery or during hospitalization
Rate of Cardiogenic death
Cardiogenic death
Measured: 30 days after surgery or during hospitalization
Rate of Severe pneumonia
new onset of Severe pneumonia
Measured: 30 days after surgery or during hospitalization
Rate of Ventilation ≥24h
Ventilation ≥24h after surgery
Measured: 30 days after surgery or during hospitalization
Rate of Pulmonary embolism
new onset of Pulmonary embolism
Measured: 30 days after surgery or during hospitalization
Rate of Re-operation for bleeding
Re-operation for bleeding after primary surgery
Measured: 30 days after surgery or during hospitalization
All-cause mortality
All-cause mortality
Measured: 1 year after surgery
Rate of Myocardial infarction
new onset of Myocardial infarction
Measured: 1 year after surgery
Rate of Stroke
new onset of Stroke
Measured: 1 year after surgery
Rate of Renal insufficiency
new onset of Renal insufficiency
Measured: 1 year after surgery
Rate of Re-hospitalization for respiratory disease
Re-hospitalization for respiratory disease
Measured: 1 year after surgery
Rate of Cardiogenic re-hospitalization
Cardiogenic re-hospitalization
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start28 Jan 2023
- Primary completion24 Mar 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690646
- Sponsor's protocol ID
- NCRC2023001
- Acronym
- PEP
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05690646
- Acronym / sponsor ID
- PEP / NCRC2023001
- Conditions
- Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NR group | Experimental | Drug: Nirmatrelvir/ritonavirnirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days |
| UA group | Experimental | Drug: Ursodeoxycholic acidursodeoxycholic acid group, 15mg/kg/day bid for5 days |
| combination group | Experimental | Drug: Nirmatrelvir/ritonavir, Drug: Ursodeoxycholic acidnirmatrelvir 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirmatrelvir/ritonavirnirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days | Drug | NR group, combination group |
| Ursodeoxycholic acidursodeoxycholic acid 15mg/kg/day bid for5 days | Drug | UA group, combination group |
Primary outcome
MACCE
Time frame: 30 days after surgery or during hospitalization
All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia
16 secondary outcomes
All-cause mortality
Time frame: 30 days after surgery or during hospitalization
Rate of Myocardial infarction
Time frame: 30 days after surgery or during hospitalization
Rate of Stroke
Time frame: 30 days after surgery or during hospitalization
Rate of Moderate to severe acute kidney injury
Time frame: 30 days after surgery or during hospitalization
Rate of COVID-19 pneumonia
Time frame: 30 days after surgery or during hospitalization
Rate of Cardiogenic death
Time frame: 30 days after surgery or during hospitalization
Rate of Severe pneumonia
Time frame: 30 days after surgery or during hospitalization
Rate of Ventilation ≥24h
Time frame: 30 days after surgery or during hospitalization
Rate of Pulmonary embolism
Time frame: 30 days after surgery or during hospitalization
Rate of Re-operation for bleeding
Time frame: 30 days after surgery or during hospitalization
All-cause mortality
Time frame: 1 year after surgery
Rate of Myocardial infarction
Time frame: 1 year after surgery
Rate of Stroke
Time frame: 1 year after surgery
Rate of Renal insufficiency
Time frame: 1 year after surgery
Rate of Re-hospitalization for respiratory disease
Time frame: 1 year after surgery
Rate of Cardiogenic re-hospitalization
Time frame: 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengshou Hu principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nirmatrelvir/ritonavir and Ursodeoxycholic acid in people with Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 30 days after surgery or during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.