COVID-19 Amyotrophic Lateral Sclerosis(ALS) Registry NCT04559009

ABSTRACT

Objective: To capture the impact of COVID-19 on ALS by creating a patient-facing observational registry. Background: This observational registry is aimed to assess the impact of COVID-19 on ALS disease trajectory to help guide future directions of care, especially the role of COVID-19 on respiratory compromise and corroborate other demographic features. Design/Methods: ALS patients, and/or caregivers invited to report demographics, COVID-19 diagnosis and treatment details via a secure registry questionnaire through a REDCap Database. Patients are recruited by open announcement/email invitations via Center for Disease Control (CDC), National ALS Registry, ALS Association (national), ALS patient support organizations, Letter to MDA, ALSA and Northeast ALS Consortium Centers as well as ClinicalTrials.gov. Results: Registered ALS patients with documented COVID-19 infection [14] completed the survey to date 9 - males;5- females. All participants were Caucasian. Mean BMI was 26.31. 62.5% had no history of tobacco use. Concomitant ALS medications included riluzole - 60%, edaravone -13.3%, dextromethorphan/quinidine -13.3%, no medications - 33.3 %. COVID-19 infection interrupted clinical trial participation - 20.0%. COVID-19 infection was treated at home in 73.3% while 26.7% were hospitalized. 13.3% were on NIV while 86.7% were not. Concomitant COVID-19 medications included Remdesivir - 14.3%, Azithromycin - 21.4%, Corticosteroids 28.6%, no COVID-19 directed therapies - 57.1%. All of the 26.7 % hospitalized patients were discharged home. Pre COVID-19 total ALSFRS R scores (28 to 47) changed minimally during COVID-19 (27 to 47). Conclusions: In this COVID 19 ALS Registry participants to date, there were no COVID-19 related deaths in all Caucasian, predominately riluzole treated cohort and all have returned to home care with no significant change in ALSFRS R Scores post COVID. Further recruitment is ongoing to enrich COVID-19 infected ALS patients on wider range of ALS modifying therapies and expanding spectrum of COVID-19 modifying therapies from different periods of this ongoing pandemic to define in more detail their experience.