NCT07256795
Blood-Brain Barrier Integrity and Immune Dynamics in Neuropsychiatric Sequelae of Post-SARS-CoV-2 Onset ME/CFS Versus Pre-Pandemic ME/CFS Patients
Enrolling by Invitation
Not specifiedAges 18–70ObservationalJohns Hopkins UniversityInvestigator-initiated
~200 participants
Updated 2026-06-11 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Permeability Surface-Area Product (PS)
Measured over Up to 5 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Alba Azola, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
18-70 years of age
At least 8th grade education
Onset of the following symptoms prior to July 2019 (Pre-SARS-CoV-2 pandemic) and meeting 2015 IOM diagnostic criteria for MECFS:
Substantial reduction in functioning and persistent and profound fatigue for at least 6 months. The person is unable to undertake the same level of activity before they became - . Their fatigue is not the result of significant exertion and is not substantially alleviated by rest.
Post-exertional malaise.
Unrefreshing sleep
At least one of the following two symptoms:
Cognitive impairment (difficulty with memory, finding words, understanding etc).
Orthostatic intolerance (symptoms like palpitations, sweating, dizziness, nausea when standing that are reduced or eliminated when lying down).
18-70 years of age
At least 8th grade education
Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the World Health Organization:
Suspected case of SARS-CoV-2 infection
Three options, A through C:
Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia.
Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization) C. Presents with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test.
Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
Confirmed case of SARS-CoV-2 infection - Two options, i. and ii.:
A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or
Meeting clinical criteria AND/OR epidemiological criteria (See suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
Post SARS CoV 2 onset of the following symptoms, meeting 2015 IOM diagnostic criteria for ME/CFS:
Substantial reduction in functioning and persistent and profound fatigue for at least 6 months. The person is unable to undertake the same level of activity before they became - - Their fatigue is not the result of significant exertion and is not substantially alleviated by rest.
Post-exertional malaise.
Unrefreshing sleep.
At least one of the following two symptoms:
Cognitive impairment (difficulty with memory, finding words, understanding etc).
Orthostatic intolerance (symptoms like palpitations, sweating, dizziness, nausea when standing that are reduced or eliminated when lying down).
Given that our application focuses on MECFS patients with neuropsychiatric symptoms the investigators will require participants to report \>1 symptom with at least one of the symptoms being neuropsychiatric in nature (e.g., brain fog, anxiety, depression, headaches).
History of Axis I psychiatric disorders (including alcohol and drug dependence) except for mood disorders which developed after onset of ME/CFS symptoms.
Severe or unstable medical condition that would interfere with physical participation.
Neurological disorders, such as stroke, epilepsy, multiple sclerosis, Parkinson's disease, or dementia.
History of severe head injury that resulted in persistent traumatic brain injury sequelae.
Any condition that is contraindicated for the MRI environment (e.g., metal in the body, pacemaker, claustrophobia)
Currently pregnant.
Lack of English proficiency (to ensure validity in verbal outcome measures)
Active or recent (within 3 months) substance misuse (which is known to affect BBB permeability) assessed by clinical interview and toxicology (nicotine/cannabis allowed)
History of psychosis
What this trial measures
- Permeability Surface-Area Product (PS)Up to 5 years
Investigate BBB permeability in MECFS patients using WEPCAST MRI as measured by Permeability Surface-Area Product (PS)
- Inflammatory biomarkers levelsUp to 5 years
Inflammatory biomarkers levels and their relation to BBB or and its relationship to cognitive impairments