NCT05233605 Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation
| NCT ID | NCT05233605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Severe COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 72 participants |
| Start Date | 2022-03-21 |
| Primary Completion | 2026-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 72 participants in total. It began in 2022-03-21 with a primary completion date of 2026-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ICU Patients admitted after ARDS due to COVID infection should be weaned from invasive mechanical ventilation as quickly as possible. 60% of ARDS patient after COVID infection admitted in ICU developp a delirium during mechanical ventilation weaning, serious event that can lead to death or acute and late complications since 30% of patients who had a delirium in ICU develop cognitive sequelae. Based on epidemiological arguments and mouse models, severe neuroinflammation is considered to be one of the physiopathological mechanisms causing delirium during ventilatory weaning. In addition to its sedative properties, dexmedetomidine exhibits neuroprotective effects. In experimental models, dexmedetomidine reduces brain inflammation acting directly on the microglial phenotype. The role of this chronic neuroinflammatory condition on cognitive abilities and reserve begins to emerge in the literature no matter the initial stress is (surgery, head trauma, or Alzheimer's type dementia) and is therefore able to influence quality of life. The evaluation of this neuroinflammation by non-invasive tools appears essential in the management and follow-up of post-COVID cerebrolesed patients, as well as the potentially neuroprotective evaluation of dexmedetomidine.
Eligibility Criteria
Inclusion Criteria: * Adult patient (age ≥ 18 years at the time of inclusion) under 75 years old * COVID-19 infection documented by PCR test performed on a nasopharyngeal swab or from a bronchoalveolar sample * High affinity homozygous TPSO genotyping for \[18F\] -DPA-714 or heterozygous intermediate affinity for \[18F\] -DPA-714 * Patient who was hospitalized in intensive care for ARDS after COVID infection which required mechanical ventilation and deep sedation for at least 24 hours * Patient alive at 24 months (+ 24 months) after discharge from intensive care * Signature of informed consent * Patient affiliated to a National French social security system, excluding (French) State Medical Aid (SMA) For the group of patients exposed to dexmedetomidine: * Administration of dexmedetomidine for at least 24 hours during intensive care hospitalization For the group of patients not exposed to dexmedetomidine: * No administration of dexmedetomidine during intensive care hospitalization Exclusion Criteria: * Protected adult (under legal protection, guardianship or curatorship) * Pregnancy or breast-feeding * Contraindication to PET or MRI examination * Severe renal impairment (creatinine clearance \<30 mL / min) * Contraindication to the administration of the radiopharmaceutical agent \[18F\]-DPA-714 * Serious neurological history at admission to intensive care: * Stroke * Severe head trauma * Dementia with loss of autonomy
Contact & Investigator
Vincent DEGOS, Pr
STUDY DIRECTOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05233605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Severe COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05233605 currently recruiting?
Yes, NCT05233605 is actively recruiting participants. Contact the research team at vincent.degos@aphp.fr for enrollment information.
Where is the NCT05233605 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05233605 clinical trial?
NCT05233605 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Vincent DEGOS, Pr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 72 participants.
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