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CO-MY-COVID
Sponsor study identifier
observational
34
1 country
10
Study Start
April 27, 2020
Actual (reported)Primary Completion
June 18, 2020
Actual (reported)Study Completion
June 18, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 18, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2020
Actual (reported)June 18, 2020
Actual (reported)June 18, 2020
Actual (reported)December 31, 2020
Actual (reported)January 5, 2021
Actual (reported)Severity of Myasthenia Gravis evaluated by the Myasthenia Gravis of America (MGFA) score
The severity of MG is measured by using the MGFA (Myasthenia Gravis Foundation of America) classification, giving the status of 'MG-improvement' (when the scores decreased or remained stable) or 'MG-worsening' (when the scores increased) (Jaretzki A, 3rd, Barohn RJ, Ernstoff RM, et al. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology 2000;55:16-23.)
1 month after the inclusion visit
Severity of Myasthenia Gravis evaluated by the Myasthenia Gravis of America (MGFA) score
at inclusion (at the time of the COVID-19 diagnosis)
Severity of Myasthenia Gravis evaluated by the variation of the Myasthenia Gravis of America (MGFA) score
3 months after the inclusion visit
Severity of Myasthenia Gravis evaluated by the variation of the Myasthenia Gravis of America (MGFA) score
6 months after the inclusion visit
The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
at inclusion (at the time of the COVID-19 diagnosis)
The autonomy of the patients evaluated with the MG-ADL (Myasthenia Gravis-Activities of Daily Living) scale
1 month after the inclusion visit
Child or adult patients, living or deceased, presenting or having presented a myasthenic syndrome and a COVID-19 infection
CHU d'Angers
Angers, 49933, France
CHU de Bordeaux
Bordeaux, 33076, France
Hospices Civils de Lyon
Bron, 69677, France
APHP - Hopital Raymond Poincarré
Garches, 92380, France
CHRU de Lille
Lille, 59037, France
Assistance Publique Hôpitaux de Marseille
Marseille, 13385, France
CHU de Nantes
Nantes, 44093, France
Guilhem SOLE, MD
Université Hospital, Bordeaux
34 participants (actual enrollment reported by the registry).
First Submitted
December 31, 2020
First Posted
January 5, 2021
Study Start
April 27, 2020
Actual (reported)Contact the study team to confirm eligibility.
APHP GH Pitié Salpétrière
Paris, 75013, France
CHU de Strasbourg
Strasbourg, 67098, France
CHU de Toulouse
Toulouse, 31059, France
Primary Completion
June 18, 2020
Actual (reported)Study Completion
June 18, 2020
Actual (reported)Last Updated
October 6, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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