Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammatio

Phase 1

• Conditions: All patients who have developed and survived ARDS linked to COVID-19 infection, admitted to intensive care units, meeting the study's inclusion criteria may be included in this research.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004802-70-FR
• Lead Sponsor: Assistance Publique – Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-29
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Adult patient (age = 18 years at the time of inclusion) under 75 years old
• COVID-19 infection documented by nasopharyngeal pCR test.
• High affinity homozygous TPSO genotyping for the radiotracer or heterozygous intermediate affinity for the radiotracer
• Patient who was hospitalized in intensive care for an ARDS following the COVID infection requiring mechanical ventilation and deep sedation for at least 48 hours.
• Patient alive 12 months (+/- 3 months) after discharge from intensive care
• Signature of free and informed consent
• Patient affiliated to a social security scheme, excluding AME (state medical aid)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

• Protected adult (under legal protection, under guardianship or curatorship)
• Pregnancy or breast-feeding
• Allergy to dexmedetomidine
• Contraindication to a PET or MRI examination
• Severe renal failure
(creatinine clearance <30 ml / min)
• Serious neurological history on admission to intensive care:
o Stroke
o Severe head trauma
o Insane state with loss of autonomy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified