COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Study Purpose:

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal neurodegenerative disease characterized by progressive weakness involving limb, bulbar, and respiratory muscles.There is currently no information suggesting how COVID-19 affects patients diagnosed with amyotrophic lateral sclerosis (ALS). This is especially important as respiratory compromise is common in ALS patients and can complicate the clinical course as COVID-19 could lead to respiratory failure and need for intubation. We intend that this registry will guide our understanding of how COVID-19 affects patients with ALS.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Urvi Desai, MD Neurologist/MDA Director

Clinicaltrials.gov ID (11 digit #):

NCT04559009

Neals Affiliated?

No

Coordinating Center Contact Information

Neurosciences Institute
Erica Gowan, MS / .(JavaScript must be enabled to view this email address) / 704-446-1982
Allison Newell-Sturdivant, MSN, BSN / .(JavaScript must be enabled to view this email address) / 704-355-5285
Charlotte, North Carolina 28207

Full Study Summary:

The purpose of this registry is to assess the incidence and prevalence of COVID-19 in ALS patients, the effect of COVID-19 on ALS disease trajectory, and the impact, if any, of edaravone, riluzole and other concomitant medication used in ALS like Albuterol and dextromethorphan/quinidine (Nuedexta) on these parameters. COVID-19 incidence and prevalence in the ALS population will be assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.

Study Sponsor:

Atrium Health

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

10/15/2020

Estimated Study Completion Date:

04/30/2024

Posting Last Modified Date:

01/07/2021

Date Study Added to alsconsortium.org:

12/07/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Diagnosis of ALS and

    A confirmed COVID-19 infection determined by:

    • positive SARS-CoV-2 viral RNA PCR test and/or
    • positive serology antibody testing for SARS-CoV-2

    Exclusion Criteria:

    No ALS diagnosis
    No confirmed COVID-19 infection

  • Site Contact Information

    Neurosciences Institute
    Erica Gowan, MS / .(JavaScript must be enabled to view this email address) / 704-446-1982
    Allison Newell-Sturdivant, MSN, BSN / .(JavaScript must be enabled to view this email address) / 704-355-5285
    Charlotte, North Carolina 28207
    United States