NCT05690646

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
491

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

January 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

April 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 9, 2023

Last Update Submit

April 7, 2023

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • MACCE

    All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia

    30 days after surgery or during hospitalization

Secondary Outcomes (16)

  • All-cause mortality

    30 days after surgery or during hospitalization

  • Rate of Myocardial infarction

    30 days after surgery or during hospitalization

  • Rate of Stroke

    30 days after surgery or during hospitalization

  • Rate of Moderate to severe acute kidney injury

    30 days after surgery or during hospitalization

  • Rate of COVID-19 pneumonia

    30 days after surgery or during hospitalization

  • +11 more secondary outcomes

Study Arms (4)

NR group

EXPERIMENTAL

nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days

Drug: Nirmatrelvir/ritonavir

UA group

EXPERIMENTAL

ursodeoxycholic acid group, 15mg/kg/day bid for5 days

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

Drug: Nirmatrelvir/ritonavirDrug: Ursodeoxycholic acid

control group

NO INTERVENTION

No intervention

Interventions

Nirmatrelvir/ritonavirDRUG

nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days

NR groupcombination group
Ursodeoxycholic acidDRUG

ursodeoxycholic acid 15mg/kg/day bid for5 days

UA groupcombination group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Emergency surgery
  • eGFR ≤30ml/min
  • Severe liver dysfunction
  • Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 10010, China

Location

MeSH Terms

Interventions

nirmatrelvir and ritonavir drug combinationUrsodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Shengshou Hu

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 19, 2023

Study Start

January 28, 2023

Primary Completion

March 24, 2023

Study Completion

January 6, 2026

Last Updated

April 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)