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Study on Aspirin's Role in Reducing COVID-19 Risk for Patients with Aspirin-Exacerbated Respiratory Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as aspirin-exacerbated respiratory disease (AERD). AERD is a respiratory condition that can worsen with the use of aspirin. The study is investigating whether long-term use of aspirin, specifically a 300 mg tablet form known as ACARD, can reduce the risk of infection with the SARS-CoV-2 virus, which causes COVID-19, in patients with AERD.

The purpose of the study is to see if aspirin, which works by blocking a specific enzyme in the body, can help predict a lower chance of getting infected with the virus. The study will also look at certain genetic features that might influence how the body responds to the virus when taking high doses of aspirin. Participants will be given either aspirin or a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, researchers will monitor changes in specific genes that might be linked to a reduced risk of SARS-CoV-2 infection. The study will last for a period of time, during which participants will take the medication and have regular check-ups to assess their health and any changes in their condition. The goal is to better understand how aspirin might help in managing the risk of COVID-19 in people with AERD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

    You must be between 18 and 70 years old and meet specific health criteria. For patients with aspirin-exacerbated respiratory disease (AERD), your lung function must be at least 70% of the predicted value. If you are a healthy control participant, you must not have asthma.

  2. Step 2

    Medication administration

    You will be given a medication called ACARD 300 mg, which contains acetylsalicylic acid. This is commonly known as aspirin.

    The medication is in the form of a tablet and is taken orally. The dosage and frequency will be determined by the study team based on your specific needs and health status.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular assessments of your lung function and other health parameters.

    You may be asked to provide samples, such as sputum or nasal cells, to help assess the effects of the medication on your body.

  4. Step 4

    Study duration

    The study is expected to continue until February 28, 2025. Your participation may last for the entire duration or a portion of it, depending on your health and the study's requirements.

    Regular follow-ups will be scheduled to ensure your safety and to gather necessary data for the study.

Who can join the trial?

6 criteria

  • Must sign an informed consent form, which means you agree to participate after understanding the study.
  • Must be between 18 and 70 years old.
  • For patients with aspirin-exacerbated respiratory disease (AERD):
    • Must have a baseline FEV1 of at least 70% of the predicted value. FEV1 is a measure of how much air you can forcefully exhale in one second, and it helps assess lung function.
    • Must not be pregnant, and if you are of childbearing potential, you must use highly effective contraception.
    • For healthy control participants:
      • Must be in healthy condition.
      • Must not have asthma.

Who cannot join the trial?

3 criteria

  • Patients who do not have aspirin-exacerbated respiratory disease cannot participate. This is a condition where taking aspirin can worsen breathing problems.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Aspirin is a medication commonly used to relieve pain, reduce inflammation, and lower fever. In this clinical trial, aspirin is being studied to see if it can help reduce the risk of getting infected with the virus that causes COVID-19, especially in people who have a condition called aspirin-exacerbated respiratory disease (AERD). This condition makes it hard for some people to breathe when they take aspirin, but the study is looking at whether taking aspirin regularly might actually help protect against the virus. The trial is also exploring if certain genetic traits in people might make aspirin more or less effective in preventing the infection.

What is already known about the treatment

Aspirin – Aspirin is typically taken orally in the form of tablets. It is a well-known medication used for its anti-inflammatory and pain-relieving properties, and it is currently being studied for its potential to reduce the risk of SARS-CoV-2 infection in individuals with aspirin-exacerbated respiratory disease (AERD). The main therapeutic use of aspirin in this context is to see if it can lower the chances of getting COVID-19. Aspirin works by blocking an enzyme called cyclooxygenase-1, which plays a role in inflammation and blood clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Aspirin-Exacerbated Respiratory Disease – Aspirin-Exacerbated Respiratory Disease (AERD) is a chronic medical condition characterized by asthma, nasal polyps, and sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). The disease progresses with respiratory symptoms such as wheezing, coughing, and shortness of breath, often triggered by aspirin or NSAID intake. Over time, individuals with AERD may experience worsening asthma symptoms and recurrent nasal polyps, which can lead to nasal congestion and loss of smell. The condition is associated with an overproduction of leukotrienes, inflammatory chemicals in the body. AERD can also lead to chronic sinusitis, a persistent inflammation of the sinuses. The progression of symptoms can vary among individuals, with some experiencing more severe respiratory issues than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-514602-31-00Protocol codeAERD-COV19Estimated enrolment76 patientsSponsorUniwersytet Jagiellonski Collegium Medicum

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