COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

NCT ID: NCT04559009

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Covid19 Amyotrophic Lateral Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urvi Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Neurologist/ MDA Director

Locations

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Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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AH-NSI-COVID19-ALS

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082131

Identifier Type: -

Identifier Source: org_study_id

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