Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammation (PET-DEXDOCOVID)

This research is investigating whether a drug called dexmedetomidine can help prevent long-term brain inflammation in people who were seriously ill with COVID-19 and needed a life support machine in intensive care. Many patients who survive severe COVID-19 can experience confusion and other thinking problems, which might be linked to inflammation in the brain. Dexmedetomidine is a medicine often used to help patients relax, but it might also have protective effects on the brain. The study will use special brain scans two years after patients leave intensive care to see if dexmedetomidine can reduce this inflammation. The aim is to understand if this medicine can improve brain recovery and quality of life for these patients in the long run.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

04 Oct 2024

Patients who survive a COVID ARDS in intensive care must be weaned off invasive mechanical ventilation as quickly as possible. 60% of these patients present with intensive care delirium a serious event that causes excess mortality and potential acute and late complications since 30% of patients who present with delirium develop cognitive sequelae. Severe neuroinflammation is considered to be one of the main pathophysiological mechanisms causing delirium during ventilatory weaning. In addition to its sedative properties dexmedetomidine has neuroprotective effects. In certain experimental models it reduces cerebral inflammation by acting directly on the microglial phenotype. The role of this chronic neuroinflammatory state on cognitive capacity and reserve is beginning to emerge in the literature regardless of the initial stress (surgery head injury or Alzheimer's-type dementia)and is therefore capable of influencing patients' quality of life. The assessment of this neuroinflammation using non-invasive tools would appear to be of prime importance in the management of post-COVID neuro injured patients as well as the evaluation of potential neuroprotective agents such as dexmedetomidine.

What is this study about?

When people get very sick with COVID-19 and need help breathing in intensive care, it can sometimes lead to serious problems like confusion, which doctors call delirium. This delirium can have lasting effects on thinking and memory for some patients. We believe that a special type of inflammation in the brain might be a main reason for this delirium and the long-term thinking problems that can follow.

This study, called PET-DEXDOCOVID, is looking at a medicine called dexmedetomidine. This medicine is already used to help patients relax, but some early research suggests it might also protect the brain and reduce inflammation. We want to find out if giving dexmedetomidine to very sick COVID-19 patients in intensive care can help prevent or reduce this brain inflammation that can last for a long time after they leave the hospital.

To do this, we'll be using special brain scans called PET-MRI scans about two years after patients leave intensive care. These scans help us see how much inflammation is present in certain parts of the brain. By comparing patients who received dexmedetomidine with those who didn't, we hope to understand if this medicine can make a real difference in their brain health and overall quality of life in the years following their illness.

Key takeaways

This study aims to improve long-term brain health after severe COVID-19.
It investigates if a medicine called dexmedetomidine can reduce brain inflammation.
Brain scans will be used to check for inflammation two years after intensive care.
The goal is to understand if treatment can help with thinking and memory.
The study focuses on adults who needed breathing support for COVID-19.
Participation involves routine care with special follow-up scans and tests after two years.

Who may be eligible?

This study is open to adults aged 18 and over, no matter how old they are. Both men and women can take part.

To be included, you would have been seriously ill with COVID-19 and spent time in intensive care needing a breathing machine. The study specifically looks at patients who have just survived this critical illness and are being carefully taken off the breathing machine.

There might be other health reasons that decide if you can join, which the study team will discuss with you. Their main goal is to make sure the study is safe and right for everyone involved.

Quick self-check

Are you 18 years old or older?
Did you become very ill with COVID-19?
Did you need life support (a breathing machine) in intensive care due to COVID-19?
Are you currently being helped to come off the breathing machine?
Are you open to having follow-up brain scans and thinking tests two years after leaving intensive care?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you would primarily be part of the care you already receive in intensive care. The main difference would be that you might receive a specific medication, dexmedetomidine, or another standard sedative, as part of your treatment plan while you are being weaned off the breathing machine.

The most significant follow-up for this study happens much later. About 24 months (two years) after you leave intensive care, you would be asked to come back for some special assessments. This would include brain scans, specifically called PET-MRI scans, to look for signs of brain inflammation. You would also have some tests to check your memory and thinking skills. There might be some blood tests to look at other body signals. The total duration of your active involvement in terms of assessments would mainly be focused around this two-year follow-up, though the initial medication would be given during your intensive care stay.

Potential risks and benefits

Taking part in this study might offer a potential benefit of receiving a treatment that could help reduce long-term brain inflammation, which in turn might improve your thinking and memory after a severe COVID-19 illness. However, like all medicines, dexmedetomidine has potential side effects, and the study team will discuss these with you. There are also very small risks associated with brain scans, which are standard medical procedures. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

—
France

Common questions

What is 'brain inflammation'?

Brain inflammation is when the brain's immune system gets overly active, similar to how your body reacts to an injury. In this study, we're looking at a type that might cause long-term thinking problems after severe COVID-19.

What is dexmedetomidine?

Dexmedetomidine is a medicine often given in intensive care to help patients relax and sleep. We're also studying if it can help protect the brain from inflammation.

What is a PET-MRI scan?

A PET-MRI scan is a special type of brain scan that combines two powerful imaging methods. It helps doctors see soft tissues in your brain and also detect signs of inflammation using a small amount of a special tracer.

Will I know if I'm getting dexmedetomidine?

Because this is a study, patients are usually assigned to receive either the study drug or standard care by chance, a bit like flipping a coin. You might not know which one you receive, but the study team will explain everything.

What happens if I decide not to take part?

If you choose not to take part, your medical care will not change in any way. You will continue to receive the best standard treatment available for your condition.