COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

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.

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Key information

Conditions

Covid19 Amyotrophic Lateral Sclerosis COVID-19 Central Nervous System Diseases Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral Proteostasis Deficiencies RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases TDP-43 Proteinopathies Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Sep 22, 2020
Registry last updated: Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed