NCT04413864

Brief Summary

Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal. Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

June 21, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

April 21, 2020

Last Update Submit

June 18, 2021

Conditions

SARS-CoV 2

Keywords

SARS-CoV-2Covid-19DexmedetomidineNeuroinflammation

Outcome Measures

Primary Outcomes (1)

  • Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months

    Month6

Secondary Outcomes (4)

  • Change of interrelationship between inflammation (cytokines levels) and ICU delirium in Covid19 + patient from Baseline at 6 months

    Month6

  • Modification in inflammatory genes expressed (expressed / non expressed) in PBMC between Baseline and M6

    Month6

  • Change in quantity of chromatine's openings (chromatin accessibility profiles) in ICU patient recovering from covid19 infection

    Day2, Month6

  • Change in genes expression in Covid-19 patient with delirium in ICU between Day2 and Month6

    Day2, Month6

Study Arms (1)

SARS-CoV-2 (Covid-19 positive)

OTHER

Patients hospitalized in intensive care unit (ICU), infected with SARS-CoV-2

Other: Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration

Interventions

Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administrationOTHER

Assigned Interventions: * Blood samples collection at inclusion (D0) and follow-up visits (D2, D7 and M6) * CAM-ICU scores during ICU hospitalisation, neurological questionnaires at M6 (GOAT, GOSE, MOCA, Barthel Index, PTSD, GDS, Rankin score, HADS)

SARS-CoV-2 (Covid-19 positive)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized in intensive care unit (ICU)
  • Administration of dexmedetomidine scheduled for 7 days
  • Intubated/ventilated patient infected with SARS-CoV-2 (Covid-19 positive patient)
  • Patient affiliated to a social security system (French State medical aid excluded)
  • Hemoglobin level ≥ 9 g /dL

You may not qualify if:

  • Protected major (under safeguardship, curatorship or guardianship)
  • Pregnancy or breastfeeding
  • Contra-indication to dexmedetomidine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

COVID-19Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent DEGOS, Pr

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Vincent DEGOS, Pr

CONTACT

142163761vincent.degos@aphp.fr

Alice JACQUENS

CONTACT

688652473alice.jacquens@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: open-label monocentric cohort study, with intervention added
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

June 4, 2020

Study Start

April 24, 2020

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

June 21, 2021

Record last verified: 2021-05

Locations

FR(1)