Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery
NCT ID: NCT05690646
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
491 participants
INTERVENTIONAL
2023-01-28
2026-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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NR group
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
UA group
ursodeoxycholic acid group, 15mg/kg/day bid for5 days
Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
combination group
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days and ursodeoxycholic acid group, 15mg/kg/day bid for5 days
Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
control group
No intervention
No interventions assigned to this group
Interventions
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Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
Eligibility Criteria
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Inclusion Criteria
* 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
* eGFR ≤30ml/min
* Severe liver dysfunction
* Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Shengshou Hu
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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NCRC2023001
Identifier Type: -
Identifier Source: org_study_id
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