By InvitationNot Applicable

Blood-Brain Barrier Integrity and Immune Dynamics in Neuropsychiatric Sequelae of Post-SARS-CoV-2 Onset ME/CFS Versus Pre-Pandemic ME/CFS Patients

United States200 participantsStarted 2026-06-01

Plain-language summary

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex chronic illness impacting multiple body systems and characterized by activity-limiting fatigue and post exertional symptom exacerbation, affecting over 3.5 million adults in the US and as many as half of those with long COVID. The mechanisms behind the frequently profound cognitive impairments in MECFS are elusive; however, disruption of the integrity of the blood brain barrier (BBB) and immune cell migration into the brain are thought to contribute to neuroinflammation and related neuropsychiatric burden in MECFS. This project combines brain imaging, neuropsychiatric assessments, and blood-based measures of inflammation in pre-pandemic and post-pandemic individuals with MECFS to understand the role of BBB permeability and inflammation as contributors to key aspects of cognition and mood.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion criteria for pre-pandemic onset ME/CFS cohort: * 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). Inclusion criteria post SARS-CoV-2 onset ME/CFS: * 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: Meets the clinical OR epidemiological criteria. * 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: …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial seems to be looking at blood-brain barrier permeability and immune markers in people with ME/CFS — what does that actually mean in terms of what they would do to my body during the study, and are any of those procedures risky for someone in my condition?
2Since this study is 'enrolling by invitation only,' how would I even find out if I'm eligible, and is there a way you could help connect me with the research team to see if I qualify?
3The trial is comparing people who developed ME/CFS after COVID-19 with people who had ME/CFS before the pandemic — given my own history, which group would I likely fall into, and does that affect whether this study would even be relevant to me?
4Because this is listed as Phase NA, which suggests it's an observational or mechanistic study rather than a treatment trial, I want to make sure I understand — would participating in this study actually change or add to my treatment in any way, or is it purely for research purposes?
5If I were to take part in this study, how demanding would it be logistically in terms of visits, tests, or travel, and given how debilitating my symptoms can be, is this something you think would realistically be manageable for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Permeability Surface-Area Product (PS)

Timeframe: Up to 5 years

Inflammatory biomarkers levels

Timeframe: Up to 5 years

Trial details

NCT IDNCT07256795

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12

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