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Could a COVID-19 pill shield heart surgery patients from complications?

NCT ID NCT05690646

Prevention Sponsor: China National Center for Cardiovascular Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether giving two drugs—nirmatrelvir/ritonavir (Paxlovid) and ursodeoxycholic acid—before open-chest heart surgery can reduce serious complications in people who have previously had COVID-19. Participants are randomly assigned to receive one of the drugs or a placebo for five days around the time of surgery. The study tracks outcomes like death, heart attack, stroke, kidney injury, and COVID-19 pneumonia to see if either drug offers protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nirmatrelvir/ritonavir (Paxlovid) and ursodeoxycholic acid
What this could lead to
If effective, these drugs could become a standard preventive treatment to lower the risk of serious complications after heart surgery in people who have had COVID-19.
What could go wrong
This is a relatively small, early-stage trial, and the drugs may not reduce complications. There are also risks of side effects and drug interactions, especially in surgical patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

491 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery

Contacts and locations

Locations

  • Fuwai Hospital

    Beijing, Beijing Municipality, 10010, China

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