Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Long-term aspirin therapy as a predictor of decreased susceptibility to SARSCoV-2 infection in aspirin-exacerbated respiratory disease

This study is investigating a specific group of people who have a condition called Aspirin-Exacerbated Respiratory Disease (AERD). We want to find out if a long-term treatment involving aspirin can help protect them from catching COVID-19. First, participants undergo a process called 'desensitisation' to aspirin, which helps their body tolerate it. After this, they take a higher dose of aspirin for a longer period. Researchers will check if this treatment changes the way certain genes behave in their nose and lung samples. These genes are thought to play a role in how the body reacts to viruses like SARS-CoV-2, which causes COVID-19. Ultimately, the study aims to see if these gene changes are linked to a lower chance of getting infected with COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Uniwersytet Jagiellonski Collegium Medicum

Enrolment target

Start

01 Jul 2024

aspirin-exacerbated respiratory disease

What is this study about?

This study is looking at a condition called Aspirin-Exacerbated Respiratory Disease (AERD). People with AERD can have breathing difficulties, nasal polyps, and asthma when they take aspirin. Researchers want to understand if a special treatment for AERD might also offer some protection against COVID-19.

The treatment involves two main steps. First, participants go through 'desensitisation' – this is a careful process where small amounts of aspirin are given, gradually increasing the dose until the body learns to tolerate it. After this, they take a higher dose of aspirin every day for a long time. The study will be looking closely at what happens inside the body during this treatment.

Specifically, the researchers will collect samples from the nose and lungs (like mucus or cells) and examine the activity of certain genes. Some of these genes are known to be involved in how our bodies catch and fight off viruses, including the one that causes COVID-19 (SARS-CoV-2). The main question is whether this long-term aspirin treatment changes these genes in a way that makes it harder for the COVID-19 virus to infect someone, or reduces the severity of the infection.

Key takeaways

This study explores a potential link between an AERD treatment and COVID-19 risk.
It involves aspirin desensitisation followed by long-term daily aspirin.
Researchers will examine gene activity in nose and lung samples.
The goal is to see if gene changes lead to a lower chance of COVID-19 infection.
It's for adults aged 18 and over who have Aspirin-Exacerbated Respiratory Disease.

Who may be eligible?

To join this study, you must have Aspirin-Exacerbated Respiratory Disease (AERD). This is a specific medical condition that affects how your body reacts to aspirin. If you are unsure whether you have AERD, your doctor will be able to tell you.

Participants must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially take part. The study is open to both men and women.

The study will have further detailed criteria to ensure it's safe and appropriate for you to participate. These will be discussed with you by the study team, for example, about other medications you might be taking or any other health conditions you have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have Aspirin-Exacerbated Respiratory Disease (AERD)?
Are you 18 years old or older?
Are you able to take aspirin as part of a long-term treatment plan?
Are you willing to provide samples from your nose and lungs (like mucus)?
Are you able to attend regular check-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first go through a process called aspirin desensitisation, which involves gradually increasing doses of aspirin under careful medical supervision. Once this is complete, you would then take a specific type of aspirin (ACARD 300 mg tablets, containing microcrystalline cellulose, native corn starch, and anhydrous citric acid) every day for a long period. The study would involve regular check-ups to monitor your health and collect samples, such as from your nose and lungs (sputum and nasal cells). These samples would be used to check how certain genes are behaving. The total duration of your participation would depend on the study's specific plan, which will be explained in detail by the research team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is understanding if long-term aspirin therapy, after desensitisation, can help protect people with AERD from COVID-19. This could be a significant step in managing both conditions. However, taking aspirin long-term has known risks, such as stomach upset, bleeding, or other allergic reactions. The research team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is Aspirin-Exacerbated Respiratory Disease (AERD)?

AERD is a condition where taking aspirin or other similar pain relievers causes breathing problems, like asthma attacks or nasal polyps.

What does 'aspirin desensitisation' mean?

It's a medical procedure where you're given very small doses of aspirin that are gradually increased until your body learns to tolerate it without experiencing reactions.

What kind of aspirin will I be taking?

You will be taking ACARD 300 mg tablets daily, which contain specific additional ingredients like microcrystalline cellulose, corn starch, and citric acid.

What are 'gene expressions'?

This refers to whether certain genes are active or inactive in your cells. In this study, researchers are looking at genes that might affect how you react to viruses like COVID-19.

Will this study protect me from COVID-19?

This study aims to investigate if the treatment *might* be linked to a lower risk. It's a research study to understand this link, not a guaranteed protection.