Purpose

Background: COVID-19 is an infection caused by a coronavirus. It can affect different parts of the body. For most people, it causes fevers or trouble breathing. Some people can have symptoms long after they recover. Researchers want to learn if there are signs of changes in the nervous system that may be related to COVID-19. Objective: To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering. Eligibility: People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection. Design: Participants will be screened with a medical record review. Participants will have a neurological exam. They will complete pen-and-paper tests of their memory and thinking. They will complete a smell test with 'scratch-and-sniff' booklets. They will give blood samples. Participants will have magnetic resonance imaging (MRI) of the brain. Soft padding or a coil will be placed around their head. They will lie on a table that slides in and out of the MRI scanner. They will get a contrast dye through an intravenous (IV) catheter. Participants blood pressure, blood flow, skin temperature, sweating, and breathing will be monitored. Participants will have an electrocardiogram to measure heart function. Participants will blow into a mouthpiece for several seconds. Participants will lie on a table that has a motor. The motor tilts the table. Participants will have blood drawn through an IV as the table tilts. Participants will have a lumbar puncture. A small needle will be inserted into the spinal canal to obtain fluid. Participants may repeat some tests 8 weeks to 1 year later.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female, aged at least 18 years at the time of enrollment 3. Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health 4. Positive COVID-19 test result at least six weeks prior to enrollment and exhibiting persistent neurologic symptoms evidenced by a positive response to at least one of the following: 1. Do you have ongoing issues with being lightheaded or dizzy and if so, are these issues made worse when you sit or stand up quickly? 2. Do you have ongoing issues with gait instability, problems with vision, speech, swallowing? 3. Do you have ongoing issues with sensation or strength in your face/arms/legs? 5. Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study: 1. Presence of a contraindication to research MRI brain with gadolinium, including contraindicated metal in the body, prior allergic reaction to gadolinium, eGFR <45 mmol/L, pregnancy or lactation, or claustrophobia that is unable to be adequately treated with a low dose oral benzodiazepine. 2. Contraindication to a research lumbar puncture, including use of anticoagulant medication, platelets < 50,000/microL, PT or PTT >1.5 x ULN for the NIH Clinical Center, or otherwise inability to complete the procedure. 3. Contraindication to autonomic testing, including refractory ventricular arrhythmias or symptomatic coronary artery disease. 4. A condition prior to the diagnosis of Covid-19 infection that would significantly confound interpretation of the research tests (e.g. prior diagnosis of Postural Orthostatic Hypotension Syndrome), as determined by the study investigators. 5. Fever or respiratory symptoms in the last seven days.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patient Patients with history of Covid-19 infection and persistent neurological symptoms

Recruiting Locations

More Details

NCT ID
NCT04564287
Status
Enrolling by invitation
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

Detailed Description

Study Description: This study will characterize ongoing neurologic abnormalities in those who recovered from acute COVID-19 infection yet have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are neurologic. The NIH Clinical Center provides the breadth of expertise and resources to best investigate this patient group. This study will collect a broad array of specialized neurologic testing in this group who, despite recovering from the acute SARSCoV-2 infection, continue to experience neurological symptoms. It is hypothesized that this group will have abnormalities on neurologic testing that may identify discrete phenotypes of COVID-19 sequelae. Pre-screening for this study will be done under the study, 'Post-Coronavirus Disease 19 Syndrome at the National Institutes of Health.' Potentially eligible participants will be identified under the screening arm of that study and will be referred to the study team. If deemed eligible for this study based on a review of available records and a telephone discussion with the potential participant, participants may enroll. Enrollment will include a visit to the NIH Clinical Center for informed consent and completion of the study procedures. We anticipate that the baseline study procedures will take approximately 2-3 outpatient visits to complete or the participant may be admitted as an inpatient. Participants may return for a repeat of some study procedures within 12 months if there are abnormalities noted on the baseline study procedures. Objectives: Primary Objective: To investigate structural abnormalities by brain MRI in those with prior SARS-CoV-2 infection and persistent neurologic symptoms. Secondary objective: To investigate other components of neurologic function in those with prior SARS-CoV-2 infection and persistent neurologic symptoms. Endpoints: Primary endpoint: The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect COVID-19-associated disease. Secondary endpoints: 1. Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease. 2. Autonomic testing: The number and character of test results indicating autonomic nervous system or catecholaminergic dysfunctions as evidenced by abnormal physiological and neurochemical measures at rest or in responses to the Valsalva maneuver or head-up tilting. Study Population: This study will enroll 50 participants. Description of Sites/Facilities Enrolling Participants: The NIH Clinical Center will be the site of all research studies done under this protocol. Study Duration: We anticipate that this study will begin enrollment September 2020 and will complete data analysis by December 2022. Participant Duration: Participants will complete all required study procedures within an approximately two-week time frame. Participants may return for optional follow up with a repeat of some study procedures and those participants will complete the study at that point.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.