Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection

COVID-19 Infection Clinical Trial

— MARNEVO-Covid  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04361344
• Other study ID #: CHPAU2020/02
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: October 25, 2020

Study information

• Verified date: February 2021
• Source: Centre Hospitalier de PAU
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 25, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19 Infection
• Encephalitis
• Infection
• Nerve Degeneration

Intervention

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.

Locations

Country	Name	City	State
France	CH de Pau	Pau

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de PAU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of neurodegeneration markers level	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.	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).