COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Completed

• Conditions: Covid19; Amyotrophic Lateral Sclerosis

• Registration Number: NCT04559009
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Study Start: 2020-10-15
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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Exclusion Criteria

• No ALS diagnosis
• No confirmed COVID-19 infection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 incidence and prevalence in the ALS population	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.

Trial Locations

Locations (1)

Neurosciences Institute, Neurology - Charlotte; 🇺🇸 Charlotte, North Carolina, United States