COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

March 23, 2023 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Neurosciences Institute, Neurology - Charlotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Our study population consists of qualifying cases of patients with ALS who have had a laboratory confirmed COVID-19 infection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be collected through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Urvi Desai, MD, Neurologist/ MDA Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00082131
  • AH-NSI-COVID19-ALS (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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