Study on the Effects of Dexmedetomidine on Neuroinflammation in COVID-19 ARDS Survivors

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What is this study about?

This clinical trial is focused on patients who have survived a severe lung condition known as Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19. After being treated in intensive care, many of these patients experience a condition called delirium, which can lead to long-term brain inflammation and affect memory and thinking abilities. The study is investigating whether a medication called dexmedetomidine, which is used for sedation, can help reduce this brain inflammation and improve recovery.

The trial will involve two groups of patients: those who receive dexmedetomidine and those who do not. The medication will be given through an injection into a vein. Researchers will use a special imaging technique called PET-MRI to look at the brain and measure inflammation levels. This will be done 24 months after the patients have been discharged from intensive care. The study aims to see if dexmedetomidine can help protect the brain and improve cognitive function, which includes memory and thinking skills.

Another part of the study will look at how dexmedetomidine affects brain health by using brain scans and clinical assessments. Researchers will also explore biological factors that might influence brain inflammation after severe COVID-19 infection. The goal is to better understand how to manage brain health in patients recovering from COVID-19-related ARDS and to identify any risk factors that might contribute to long-term brain inflammation.

1 joining the study

Eligibility is confirmed based on age, COVID-19 infection documentation, and specific genetic markers related to the study.

Consent is obtained, and the patient is informed about the study’s procedures and objectives.

2 hospitalization in intensive care

Patients are admitted to intensive care due to severe COVID-19 infection requiring mechanical ventilation and deep sedation for at least 24 hours.

During this period, some patients receive dexmedetomidine intravenously for at least 24 hours to prevent or treat delirium.

3 post-discharge monitoring

After discharge from intensive care, patients are monitored for 24 months.

The focus is on assessing persistent neuroinflammation and cognitive function.

4 imaging and assessment

At 24 months post-discharge, a PET-MRI scan is conducted to measure neuroinflammation using the radiopharmaceutical 18F-DPA-714.

The scan evaluates the intensity of the signal in the frontal lobes compared to the cerebellar lobes.

5 evaluation of cognitive function

Clinical assessments are performed to evaluate any neurocognitive damage acquired during the study period.

Additional MRI scans may be used to assess brain structure and function.

6 data analysis

The study analyzes the association between biological data and the persistence of neuroinflammation.

Risk factors for late neuroinflammation are identified, focusing on the effects of sedative treatments used during ventilatory weaning.

Who Can Join the Study?

Patients must be at least 18 years old and younger than 75 years old.
Must have had a COVID-19 infection confirmed by a nose swab test called a PCR test.
Must have a specific genetic type related to a substance used in brain imaging tests.
Must have been in intensive care for severe lung problems due to COVID, needing a machine to help them breathe and deep sleep medicine for at least 24 hours.
Must be alive 24 months after leaving the intensive care unit.
Must sign a form agreeing to participate after being fully informed about the study.
Must be part of a social security program, but not the state medical aid program.
For patients who received a specific medicine called dexmedetomidine: Must have received it for at least 24 hours while in intensive care.
For patients who did not receive dexmedetomidine: Must not have received it during their stay in intensive care.

Who Cannot Join the Study?

Patients who have not survived COVID-19 ARDS (Acute Respiratory Distress Syndrome) in intensive care.
Patients who are not being weaned off invasive mechanical ventilation.
Patients who do not experience intensive care delirium. Delirium is a serious condition that can cause confusion and affect thinking.
Patients who do not have severe neuroinflammation. Neuroinflammation is swelling in the brain that can affect brain function.
Patients who are not being treated with dexmedetomidine. Dexmedetomidine is a medication that can help calm patients and protect the brain.
Patients who are not within the specified age range for the study.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopitaux Universitaires Pitie Salpetriere	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	05.09.2022

Trial locations

Investigated drugs:

Dexmedetomidine is a medication used in this trial to help manage sedation in patients who have experienced severe respiratory distress due to COVID-19. The goal is to see if using this medication at the end of sedation can help prevent or treat delirium, which is a state of confusion that can occur after intensive care. The study aims to determine if this approach can reduce long-term brain inflammation, which is being measured using advanced imaging techniques.

Investigated diseases:

Acute respiratory distress syndrome

COVID-19 ARDS – Acute Respiratory Distress Syndrome (ARDS) related to COVID-19 is a severe lung condition that occurs when fluid builds up in the air sacs of the lungs, leading to reduced oxygen in the bloodstream. This condition often requires intensive care and mechanical ventilation. Patients recovering from COVID-19 ARDS may experience prolonged inflammation and cognitive issues due to the stress of the illness and treatment. Neuroinflammation can persist, potentially affecting cognitive function and quality of life. The condition is characterized by difficulty in breathing, low blood oxygen levels, and the need for oxygen therapy or mechanical ventilation. Recovery can be slow, with potential long-term effects on lung function and overall health.

Trial ID:

2024-511898-30-00

Protocol code:

APHP200491

NCT ID:

NCT04352348

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dexmedetomidine on Neuroinflammation in COVID-19 ARDS Survivors

What is this study about?

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