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Clinical Trials/NCT04559009
NCT04559009
Completed
Not Applicable

COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Wake Forest University Health Sciences1 site in 1 country47 target enrollmentOctober 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Wake Forest University Health Sciences
Enrollment
47
Locations
1
Primary Endpoint
COVID-19 incidence and prevalence in the ALS population
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
January 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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