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.Study Status:
Recruiting
Disease:
Covid19 , Amyotrophic Lateral Sclerosis
Study Type:
Observational [Patient Registry]
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Urvi Desai, MD, Neurologist/ MDA Director
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Neurosciences Institute
Erica Gowan / email hidden; JavaScript is required / 704-446-1982
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:
Wake Forest University Health Sciences
Estimated Enrollment:
100
Estimated Study Start Date:
10 / 15 / 2020
Estimated Study Completion Date:
04 / 30 / 2024
Posting Last Modified Date:
06 / 13 / 2022
Date Study Added to neals.org:
09 / 22 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:- Diagnosis of ALS and
- A confirmed COVID-19 infection determined by:
1. positive SARS-CoV-2 viral RNA PCR test and/or
2. positive serology antibody testing for SARS-CoV-2
Exclusion Criteria:
- No ALS diagnosis
- No confirmed COVID-19 infection
Neurosciences Institute, Neurology - Charlotte | Recruiting
Erica L Gowan, MS / 704-446-1900 / email hidden; JavaScript is required
Allison Newell-Sturdivant, BSN / 704-446-1900 / email hidden; JavaScript is required
Principal Investigator : Urvi Desai, MD
Charlotte, North Carolina
28207
United States
Sub-Investigator : Leo McCluskey, MD