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
• 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
• 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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• COVID-19
• Covid19
• Motor Neuron Disease
• Sclerosis

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