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New brain scans aim to diagnose long COVID's hidden damage

NCT ID NCT05615415

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses advanced PET and MRI scans to look for brain inflammation and blood vessel problems in 30 people with long COVID who have brain fog, anxiety, or depression. The goal is to develop better ways to diagnose these lingering symptoms, not to test a treatment. Participants will have brain scans and provide blood samples.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

30 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The population will include neuropsychiatric PASC patients, as well as patients with a history of SARS-CoV-2 but no NP-PASC. Potential participants may be directly identified, referred through the ongoing PASC projects at NYU Neurology, identified by the NYU Radiology research coordinators, or recruited via ads. Recruitment will strive to match the two groups in age, sex and BMI.

Ages

18 to 50 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neuropsychiatric symptoms are defined as respectively a) objective cognitive dysfunction on bedside cognitive testing (ACE-III (Addenbrooke's Cognitive Examination III) =\< 86/100, at least 12th grade educational level), and/or b) anxiety, depression or psychotic illness as indicated by the DSM-5 diagnostic criteria, evaluated with the MINI (Mini International Psychiatric Interview) or SCID-5 (Structured Clinical Interview for DSM-5 Disorders, Research Version). It is expected some patients may fall into both categories (cognitive and psychiatric complications), in which case they will be included in this study. * Infection with SARS-CoV-2 (3-12 months before study) will be verified based on positive PCR test results provided by the NYU EMR or subject records. Investigators will further record the clinical history and perform nucleoprotein- and spike-antibody testing. Anecdotal evidence shows that anti-nucleoprotein and anti-spike tests will be positive in individuals who had past SARS-CoV-2 infection, but only anti-spike tests will be positive in individuals who were vaccinated but did not have past infection, unless the infected individual has already lost the antibodies due to natural infection . * Able to sign informed consent as evaluated by the UCSD Brief Assessment of Capacity to Consent (UBACC) test. Subgroup Inclusion Criteria * NP-PASC subjects will have new onset a) cognitive and/or b) psychiatric symptoms following SARS-CoV-2 infection. * CC will have a history of SARS-CoV-2 infection but will not meet the criteria for any DSM-5 diagnosis and will perform within normal limits on cognitive tests. Exclusion Criteria: * If vaccinated for SARS-CoV-2, at least 3 months past the last vaccine administration. * Subjects with suicidal ideation who require inpatient or intensive level of care, as determined by a study clinician (Dr. Frankle or Dr. Iosifescu) based on the answers to the screening interview. These patients will be immediately referred to appropriate clinical treatment. * Pregnant women or those who become pregnant as determined by a urine test at the time of the blood test and on the day of the PET/MR scan. * Obese individuals (BMI \>= 30) and individuals with cardiovascular risk factors (e.g., uncontrolled high blood pressure, hypercholesterolemia, current tobacco smokers or smoking in the last 12 months, diabetes mellitus). * Individuals with history of serious or unstable medical illness associated with chronic inflammation other than PASC (e.g., rheumatoid arthritis, SLE, etc). * Current traumatic brain injury. Subjects with a history of chronic pre-existing neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc), i.e. neurological symptoms should be new onset for inclusion. Patients with substance use disorders, including alcohol, active within the last 12 months. * Clinical or laboratory evidence of hypothyroidism. A thyroid stimulating hormone (TSH) test will be drawn in blood, and the patient will be excluded if TSH is abnormal. * Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding baseline. * Subjects who had recently taken psychotropic medications will be scanned only after a period greater than five half-lives since the last dose of their psychotropic medication. Subjects who choose to start treatment (with psychotropic medication) for their symptoms immediately will thus be excluded. * Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems). * Contraindications for Gadolinium-based MRI contrast (allergies to contrast agents and kidney health) * Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits of 5 rem per 12 months as confirmed by the Radiation safety questionnaire. * If CSF sampling: contraindication for a lumbar puncture (i.e. intracranial mass, bleeding diathesis, spinal developmental anomalies, or local skin infection involving the lower back). Complete blood count and coagulation studies will be drawn, and if abnormal (INR\>1.3, platelets less than 100), subjects will be able to complete imaging studies but will not be eligible for the lumbar puncture procedure part of the study. * Unable to sign informed consent or to comply with study assessments. * Urine will be collected for toxicology screening (amphetamine, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine/PCP, THC, and tricyclic antidepressants). Subjects in whom THC is found will be scanned only after abstaining for 7 days. A pregnancy test will be performed on all premenopausal women to ensure exclusion criteria are appropriately screened.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States