COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04559009

Enrollment

Registered

2020-09-22

Start date

2020-10-15

Completion date

2023-01-31

Last updated

2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Covid19

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results