Ended Therapeutic confirmatory (Phase III) 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.

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

EU CTIS ID: 2024-511898-30-00

What this study is testing

To evaluate whether treatment with dexmedetomidine at the end of sedation to prevent or treat delirium following post-COVID-19 ARDS reduces persistent neuroinflammation measured by an increase in the radio pharmaceutical DPA in the frontal lobes and detected using PET-MRI at 24 months (+24 months) after discharge from intensive care.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Patients over the age of majority (age ≥ 18 years at the time of inclusion) and under 75 years of age
  • COVID-19 infection documented by nasopharyngeal PCR test.
  • - TPSO genotyping homozygous high affinity for [18F]-DPA-714 or heterozygous intermediate affinity for [18F]-DPA-714.
  • - Patient admitted to intensive care for ARDS following COVID infection requiring mechanical ventilation and deep sedation for at least 24 hours.
  • - Patient alive 24 months (+24 months) after discharge from intensive care unit
  • - Signature of free and informed consent

You likely can't join if

  • - Protected adults (under court protection, guardianship or curatorship)
  • - Poor vaccine tolerance requiring hospitalisation
  • - Pregnant or breast-feeding
  • - Contraindication to a PET or MRI scan
  • - Contraindication to the administration of the radiopharmaceutical [18F]-DPA-714
  • - Severe renal insufficiency (creatinine clearance < 30 mL/min)
See the full eligibility criteria
Who can join
  • - Patients over the age of majority (age ≥ 18 years at the time of inclusion) and under 75 years of age
  • COVID-19 infection documented by nasopharyngeal PCR test.
  • - TPSO genotyping homozygous high affinity for [18F]-DPA-714 or heterozygous intermediate affinity for [18F]-DPA-714.
  • - Patient admitted to intensive care for ARDS following COVID infection requiring mechanical ventilation and deep sedation for at least 24 hours.
  • - Patient alive 24 months (+24 months) after discharge from intensive care unit
  • - Signature of free and informed consent
  • - Patient affiliated to a social security scheme, excluding AME (state medical aid)
  • For the group of patients exposed to dexmedetomidine : - Administration of dexmedetomidine for at least 24 hours during hospitalisation in intensive care.
  • For the group of patients not exposed to dexmedetomidine : - No administration of dexmedetomidine during hospitalisation in the intensive care unit.
What rules you out
  • - Protected adults (under court protection, guardianship or curatorship)
  • - Poor vaccine tolerance requiring hospitalisation
  • - Pregnant or breast-feeding
  • - Contraindication to a PET or MRI scan
  • - Contraindication to the administration of the radiopharmaceutical [18F]-DPA-714
  • - Severe renal insufficiency (creatinine clearance < 30 mL/min)
  • - Serious neurological history on admission to the intensive care unit: o Cerebrovascular accident o Severe head trauma o Dementia with loss of autonomy
  • - New severe COVID infection of the ARDS type
  • - New severe bacterial infection of the severe sepsis type
  • - Severe surgical traumatism such as cranial trauma or polytraumatism

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.