Clinical trial NCT04695379: Follow-up of a Cohort of Patients With Myasthenic Syndrome and COVID-19 Infection
Official title: Follow-up of a Cohort of Patients With Myasthenic Syndrome and COVID-19 Infection: Consequences on the Severity of Myasthenic Syndrome and Reciprocal Impact of the Two Pathologies on Their Respective Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: COVID-19
Neuromuscular Diseases
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child or adult patients, living or deceased, presenting or having presented a myasthenic syndrome and a COVID-19 infection

Brief summary: Coronavirus disease 2019 (COVID-19), declared by the World Health Organization (WHO) as a "public health emergency of international concern" (January 31, 2020), has posed a significant threat to global health. This infectious disease, caused by the 'severe acute respiratory syndrome coronavirus-2'(SARS-CoV-2), was first reported in China at the end of 2019. As other coronaviruses, SARS-CoV-2 primarily targets the human respiratory system. The most common symptoms are fever, fatigue, and dry cough. During the second week of the disease, part of patients may progress to shortness of breath, then hypoxemia and severe pneumonia. Acute respiratory distress syndrome (ARDS), linked to some risk factors such as advanced age and underlying comorbidities (hypertension, diabetes, cardiovascular disease, and cerebrovascular disease), may be fatal and needs early supportive therapy and monitoring.

Some patients with COVID-19 experienced neurological complications including headache, dizziness, hypogeusia and/or anosmia, altered level of consciousness, strokes, seizures, and ataxia, less frequently neuromuscular disorders (NMD) such as acute inflammatory polyradiculoneuropathy. Among NMD, myasthenia gravis (MG) patients, particularly susceptible to infections causing crises, could be of special risk of COVID-19 ARDS. Some general recommendations were established for the management of NMD during the COVID-19 pandemic,with also specific recommendations for MG. However, only data on a small number of patients who were managed in hospital are currently available;in addition, only two cases of myasthenic crisis following COVID-19 were reported. For this reason, the French neuromuscular rare disease network (FILNEMUS: 'FILière NEuroMUSculaire') has created the 'CO-MY-COVID register' to describe the clinical course and prognosis of patients with COVID-19 and pre-existing myasthenic syndrome.

Detailed description: Coronavirus disease 2019 (COVID-19), declared by the World Health Organization (WHO) as a "public health emergency of international concern" (January 31, 2020), has posed a significant threat to global health. This infectious disease, caused by the 'severe acute respiratory syndrome coronavirus-2'(SARS-CoV-2), was first reported in China at the end of 2019. Nowadays, with the exception of Antarctica, COVID-19 is a worldwide pandemic that continues to spread around the world (8,065,966 known cases and 437,604 deaths in June 16, 2020; https://gisanddata.maps.arcgis.com/). As other coronaviruses, SARS-CoV-2 primarily targets the human respiratory system. Its most convincing mode of transmission is inhalation of infectious aerosols or direct contact of infected people's droplets. The most common symptoms are fever, fatigue, and dry cough. During the second week of the disease, part of patients may progress to shortness of breath, then hypoxemia and severe pneumonia. Acute respiratory distress syndrome (ARDS), linked to some risk factors such as advanced age and underlying comorbidities (hypertension, diabetes, cardiovascular disease, and cerebrovascular disease), may be fatal and needs early supportive therapy and monitoring.

Some patients with COVID-19 experienced neurological complications including headache, dizziness, hypogeusia and/or anosmia, altered level of consciousness, strokes, seizures, and ataxia, less frequently neuromuscular disorders (NMD) such as acute inflammatory polyradiculoneuropathy. Among NMD, myasthenia gravis (MG) patients, particularly susceptible to infections causing crises, could be of special risk of COVID-19 ARDS. Some general recommendations were established for the management of NMD during the COVID-19 pandemic,with also specific recommendations for MG. However, only data on a small number of patients who were managed in hospital are currently available;in addition, only two cases of myasthenic crisis following COVID-19 were reported. For this reason, the French neuromuscular rare disease network (FILNEMUS: 'FILière NEuroMUSculaire') has created the 'CO-MY-COVID register' to describe the clinical course and prognosis of patients with COVID-19 and pre-existing myasthenic syndrome.

Eligibility criteria: Inclusion Criteria:

* 1. Child or adult patients, living or deceased, presenting or having presented a myasthenic syndrome and a COVID-19 infection 2. Myasthenic syndrome is established by:

  * Either the presence of a specific antibody
  * Either the presence of specific electrophysiological abnormalities
  * Either an evocative symptomatology improved by a therapeutic test with an acetylcholinesterase inhibitor
  * Either one or two pathogenic mutation (s) in a gene involved in congenital myasthenic syndromes (dominant or recessive disease).

    3. COVID-19 infection is established by
  * Either a positive PCR test
  * Or a specific chest scanner
  * Either a positive serology
  * Either a clinical syndrome of COVID-19, validated by a committee of experts. 4. Patients affiliated or beneficiaries of a social security scheme 5. For living patients: patients who have been informed of the study and have not exercised their right of opposition or parents or holders of parental authority who have been informed of the study and have not exercised their right opposition.

For deceased patients: beneficiaries or parents / holders of parental authority having been informed of the study and not having exercised their right of objection.

Exclusion Criteria:

1. Persons placed under judicial protection

Primary outcomes:
measure: Severity of Myasthenia Gravis evaluated by the Myasthenia Gravis of America (MGFA) score
timeFrame: 1 month after the inclusion visit
Secondary outcomes:
measure: Severity of Myasthenia Gravis evaluated by the Myasthenia Gravis of America (MGFA) score
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: Severity of Myasthenia Gravis evaluated by the variation of the Myasthenia Gravis of America (MGFA) score
timeFrame: 3 months after the inclusion visit
measure: Severity of Myasthenia Gravis evaluated by the variation of the Myasthenia Gravis of America (MGFA) score
timeFrame: 6 months after the inclusion visit
measure: The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
timeFrame: 1 month after the inclusion visit
measure: The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
timeFrame: 3 months after the inclusion visit
measure: The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
timeFrame: 6 months after the inclusion visit
measure: Risk factors for severe forms of COVID-19
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: Treatments for MG at the time of the diagnosis of COVID-19
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: Diagnosis of COVID-19
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: Severity of COVID-19
timeFrame: at inclusion (at the time of the COVID-19 diagnosis)
measure: Treatments for MG during and after COVID-19
timeFrame: 1 month after the inclusion visit
measure: Treatments for MG during and after COVID-19
timeFrame: 3 months after the inclusion visit
measure: Treatments for MG during and after COVID-19
timeFrame: 6 months after the inclusion visit
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Garches
country: France
facility: APHP - Hopital Raymond Poincarré
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: APHP GH Pitié Salpétrière
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Université Hospital, Bordeaux
name: Guilhem SOLE, MD
role: PRINCIPAL_INVESTIGATOR
References: