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Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection (MARNEVO-Covid)

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ClinicalTrials.gov Identifier: NCT04361344
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de PAU

Brief Summary:
Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Encephalitis Biological: blood samples Not Applicable

Detailed Description:

In animals, coronavirus infection is commonly associated with CNS involvement:

epilepsy and ataxia are observed during Feline Infectious Peritonitis (FIP) and virus is recovered in CSF, CNS is involved with strain-dependent severity in mice and rats infected by murine hepatitis virus, and murine infection with MHV A59 strain is a model of multiple sclerosis (MS). Mice encephalitis occurs through infection of olfactory bulb and spreads along the axonal pathway. Viral antigens and neuronal apoptosis are observed in brainstem and hypothalamus, without minimal or absent inflammation.

Most COVID-19 patients with neurologic impairment displayed expected complications of severe infections (e.g. neuropathy and muscle loss, stroke) but encephalitis remained exceptional, as previously observed in SRAS. It is argued that central lesions may explain some of the clinical features ventilation failure, or disproportionate residual fatigue and cognition impairment in survivors of severe COVID infection. According to data obtained from various coronavirus infections in animals, the investigators ask if severe COVID infection in human could be associated with sub-clinical encephalitis. This clinical trial examines highly sensitive blood biomarkers of brain dysfunction in correlation with late clinical outcome. Biomarkers are neurofilament light chain (NFL) and GFAP. Clinical outcomes are death, signs of central neurologic sequellae, and fatigue. Clinical examination and blood samples will be obtained at inclusion (d0), which is mostly the entrance in intensive care unit (ICU), at day 7 (between day 4 and exit from ICU) and at day 60.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, descriptive, monocentric, non-controlled study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : January 19, 2021
Estimated Study Completion Date : January 19, 2021

Intervention Details:
  • Biological: blood samples
    Clinical examination and blood samples will be done at inclusion (day 0), at day 7 (between day 4 and exit from intensive care) and at day 60.


Primary Outcome Measures :
  1. Change of neurodegeneration markers level [ Time Frame: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7). ]
    Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection with Covid-19 (proven or probable) AND
  • possible encephalitis (at least confusion, epilepsy) OR
  • clinical severity requiring invasive ventilation.

Exclusion Criteria:

  • brain stroke
  • minor CNS dysfunction (isolated smell loss or headache),
  • absence of Covid infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361344


Locations
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France
CH de Pau Recruiting
Pau, France, 64046
Contact: Mickaël BONNAN    05 59 92 49 66    mickael.bonnan@ch-pau.fr   
Sponsors and Collaborators
Centre Hospitalier de PAU
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Responsible Party: Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT04361344    
Other Study ID Numbers: CHPAU2020/02
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de PAU:
COVID-19
encephalitis
biomarkers
neurofilament protein light
GFAP protein
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Encephalitis
Nerve Degeneration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes