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NCT04559009 Clinical Trial

COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Covid19 Clinical Trial

Official title:
COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04559009
Other study ID # IRB00082131
Secondary ID AH-NSI-COVID19-A
Status Completed
Phase
First received
Last updated
Start date October 15, 2020
Est. completion date January 31, 2023

Study information
Verified date March 2023
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Neurosciences Institute, Neurology - Charlotte Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 incidence and prevalence in the ALS population Assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry. Data will be collected through study completion, an average of 3 years
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