AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy and safety of anakinra in non-COVID-19 related ARDS. ESKA study.

This study, called ESKA, is investigating a medicine called Kineret for adults who have a severe lung condition known as Acute Respiratory Distress Syndrome (ARDS) that isn't caused by COVID-19. ARDS makes it very difficult to breathe, often requiring a machine called a ventilator to help. The main goal of this study is to see if Kineret can help patients get off the ventilator more quickly. Researchers will also be looking at other important things, like how many people survive, how long they stay in intensive care or hospital, and how well their lungs and other organs recover. This is a Phase II study, which means it's an early stage to see if the treatment works and is safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Sanitaria Universitaria Friuli Centrale

Enrolment target

Start

18 Nov 2024

Acute respiratory distress syndrome (ARDS)

What is this study about?

Imagine your lungs are like sponges, but with ARDS, they become stiff and filled with fluid, making it very hard to get enough oxygen. This serious condition often means you need help from a breathing machine called a ventilator. The ESKA study is trying to find out if a medicine called Kineret (which is a liquid given by injection) can help people with ARDS, specifically when it's not caused by COVID-19.

The main thing researchers want to discover is if patients who receive Kineret can stop using a ventilator sooner. Not needing a ventilator means your lungs are recovering, and you can generally get better more quickly. They will carefully count how many days patients can breathe on their own without the ventilator.

Beyond getting off the ventilator faster, the study will also look at how Kineret might affect other important aspects of recovery. This includes checking if it helps people survive, how it impacts the length of stay in intensive care or hospital, and if it improves how well the lungs and other organs are working. By carefully tracking these things, the study aims to understand if Kineret could be a helpful new treatment option for people suffering from ARDS.

Key takeaways

This study is testing Kineret for non-COVID-19 related ARDS.
The main goal is to help patients breathe without a ventilator sooner.
It's open to adults aged 18 and over.
It's a Phase II study, looking at effectiveness and safety.
Participation involves injections and careful medical monitoring.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have Acute Respiratory Distress Syndrome (ARDS) that is not related to a COVID-19 infection. The doctors in charge of the study will have specific medical criteria to decide if you meet the full requirements for participating.

It's important to remember that joining a clinical study is a big decision, and it's essential to discuss all the details and any other health conditions you might have with the study team.

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.

Are you 18 years old or older?
Do you have Acute Respiratory Distress Syndrome (ARDS)?
Is your ARDS NOT caused by COVID-19?
Are you able to potentially receive injections for treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medicine, Kineret, as an injection. The specific schedule and duration of these injections would be explained by the study team. Doctors and nurses would carefully monitor your breathing and overall health regularly.

This involves keeping track of how many days you can breathe without a ventilator. You would also have routine checks to see how well your lungs are working and whether your other organs are functioning normally. There would be assessments at the beginning of the study and at specific time points, including at 28 days, to see how you are responding to the treatment. The study team will explain all visits, tests, and how long you would be involved.

Potential risks and benefits

Participating in a study like this might offer a potential benefit by giving you access to a new treatment that isn't yet widely available, which could help your recovery from ARDS. However, like all medicines, Kineret can have side effects, and some are not yet fully known. The study team will explain all known or potential risks to you. You have the right to leave the study at any time, for any reason, without it affecting your 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
Italy

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid builds up in the air sacs of your lungs, making it very hard to breathe and get enough oxygen.

What is a ventilator?

A ventilator is a machine that helps you breathe by gently pushing air into your lungs when you are too unwell to breathe effectively on your own. It's often used for people with severe lung problems like ARDS.

What is Kineret?

Kineret is the name of the medicine being studied. It's given as an injection and is being tested to see if it can help people with ARDS recover their breathing.

What does 'Phase II study' mean?

Phase II means it's an earlier stage of research. The main goals are to see if the medicine works, how well it works, and to make sure it's safe for people. If successful, it would move to larger studies.

Will I definitely get the study medicine?

The study team will explain exactly how the medicine is given. Sometimes in studies, a group might receive the new medicine while another group receives standard care or a comparison. They will tell you what to expect.