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COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

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ClinicalTrials.gov Identifier: NCT04559009
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Urvi Desai, Atrium Health

Brief Summary:
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.

Condition or disease
Covid19 Amyotrophic Lateral Sclerosis

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : April 30, 2024





Primary Outcome Measures :
  1. COVID-19 incidence and prevalence in the ALS population [ Time Frame: Data will be collected through study completion, an average of 3 years ]
    Assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Our study population consists of qualifying cases of patients with ALS who have had a laboratory confirmed COVID-19 infection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559009


Contacts
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Contact: Erica Gowan 704-446-1982 erica.gowan@atriumhealth.org
Contact: Allison Newell-Sturdivant, MSN, BSN 704-355-5285 allison.newell-sturdivant@atriumhealth.org

Locations
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United States, North Carolina
Neurosciences Institute, Neurology - Charlotte Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Erica L Gowan, MS    704-446-1900    Erica.Gowan@atriumhealth.org   
Contact: Allison Newell-Sturdivant, BSN    704-446-1900    Allison.Newell-Sturdivant@atriumhealth.org   
Principal Investigator: Urvi Desai, MD         
Sub-Investigator: Leo McCluskey, MD         
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Urvi Desai, MD Neurologist/ MDA Director
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Responsible Party: Urvi Desai, Principal Investigator, Atrium Health
ClinicalTrials.gov Identifier: NCT04559009    
Other Study ID Numbers: AH-NSI-COVID19-ALS
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases