NCT04352348CompletedPhase 3
Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammation (PET-DEXDOCOVID)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 11 Sept 2024
- Start date
- 5 Sept 2022
- Lead sponsor
- Assistance Publique Hopitaux De Paris
- Diseases
- Alzheimer disease, Long COVID and ME/CFS
- NCT number
- NCT04352348
- EU CT number
- 2024-511898-30-00
- EudraCT number
- 2020-004802-70
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 72
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Poor vaccine tolerance requiring hospitalisation
- Severe surgical traumatism such as cranial trauma or polytraumatism
Other illness
- 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
Lab values
- Severe renal insufficiency (creatinine clearance < 30 mL/min)
Other
- Protected adults (under court protection, guardianship or curatorship)
- Pregnant or breast-feeding
- Contraindication to a PET or MRI scan
- Contraindication to the administration of the radiopharmaceutical [18F]-DPA-714
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.