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
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Infection Encephalitis||Biological: blood samples||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, descriptive, monocentric, non-controlled study|
|Masking:||None (Open Label)|
|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|
- 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.
- 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.
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
|CH de Pau||Recruiting|
|Pau, France, 64046|
|Contact: Mickaël BONNAN 05 59 92 49 66 firstname.lastname@example.org|