key: cord-1024011-gsmhsou7
authors: Muppidi, Srikanth; Guptill, Jeffrey T; Jacob, Saiju; Li, Yingkai; Farrugia, Maria E; Guidon, Amanda C; Tavee, Jinny O; Kaminski, Henry; Howard, James F; Cutter, Gary; Wiendl, Heinz; Maas, Matthew B; Illa, Isabel; Mantegazza, Renato; Murai, Hiroyuki; Utsugisawa, Kimiaki; Nowak, Richard J
title: COVID-19-associated risks and effects in myasthenia gravis (CARE-MG)
date: 2020-11-16
journal: Lancet Neurol
DOI: 10.1016/s1474-4422(20)30413-0
sha: 71172de7458b497cf51b2483fc60de51503faa16
doc_id: 1024011
cord_uid: gsmhsou7

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Stroke and the National Institute of Arthritis and Musculoskeletal and Skin Diseases), PCORI, Ra Pharmaceuticals, Honoraria from Alexion Pharmaceuticals, argenx BVBA, Ra Pharmaceuticals, Regeneron Pharmaceuticals and Viela Bio Inc. and non-financial support from Alexion Pharmaceuticals, argenx BVBA, Ra Pharmaceuticals and Toleranzia.

Cutter G: Dr. Cutter reports personal fees from MedDay, during the conduct of the study; personal fees for data safety monitoring boards from: Astra Zeneca, Avexis Pharmaceuticals, 

We request that physicians report patients with Autoimmune Myasthenia gravis who developed COVID-19 irrespective of severity. 2. Details related to COVID-19 diagnosis including diagnostic testing, severity, validated measures of sepsis or respiratory status, and any treatment given for COVID-19 3. MG worsening/crises with COVID-19 and any MG-specific treatment given for worsening and crises. 4. Overall outcomes during or soon after COVID-19 diagnosis including death.

This study was reviewed by the Advarra central institutional review board (IRB) and was given 'exempt' status as per U.S Department of Health and Human Services regulations found at 45 CFR (code of federal regulations) 46.104(d)(4). Further information on Advarra can be obtained at https://www.advarra.com/about-advarra/the-advarra-review-board/ (accessed on September 3, 2020).

We recommend physicians to follow local regulations regarding research study protocol and submitting de-identified information. Registry is specifically designed to avoid any identifying information and minimize or eliminate the burden on reporting physicians or faculty.

Case Report Forms:

The registry remains open and active accrual continues through electronic or paper case report form submission.

Case submission can be completed at https://myasthenia.org/For-Professionals/Resources-for-Professionals/CARE-MG).

All submitted data electronically (by REDCap) or paper form is stored at Duke Clinical and Translational Science Institute.

CARE-MG registry represents the commitment of neurologists and neuromuscular specialists from across the globe to collect key information necessary to ensure evidence-based practices for our patients with MG in a dynamic public health environment. We encourage clinicians to report all their COVID-19 MG cases irrespective of outcomes and to join the CARE-MG Study Group.

Only with robust international collaboration can we ensure our data represent the true experience of patients with MG and address critical unanswered questions related to the pandemic.

Responsive real-world data updates will be made available as cases continue to be reported by the neurology community. 

of the International MG/COVID-19 Working Group

Steering committee members actively participated in the development of study protocol and design of case reporting form and formulate overall goals of the registry. We hope to expand the study group in future to improve the gender balance and have more international representation in future as we expand the study.All clinicians who report cases are automatically included in the investigator group and we hope to acknowledge the effort by researchers. 

Laboratory confirmed, n (%) 80 (88%)Clinically suspected, n (%) 11 (12%)

Hospitalization required, n (%) 63 (69%)Outpatient management, n (%) 28 (31%)