Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 InfectionNCT05615415
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO Positron Emission Tomography (PET) and MRI
An observational study of Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection, run by NYU Langone Health at 1 site in United States.
Trial summary
The overarching goal of this study is to develop PET/MR techniques for the diagnosis of neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate neuropsychiatric PASC (NP-PASC). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection
- What is being tested?
- PET Tracer, MRI Tracer and 3T PET/MRI
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Immunological and Vascular Dysfunction in Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO PET and MRI
The overarching goal of this study is to develop PET/MR techniques for the diagnosis of neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate neuropsychiatric PASC (NP-PASC).
- Being tested
- PET Tracer, MRI Tracer, 3T PET/MRI
- Keywords
- Long COVID, COVID-19, Cognitive Deficit Following COVID-19, Depression and Anxiety following COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET TracerDrug
Also called C11-ER176
Standard radiopharmaceutical injected via intravenous catheter during PET-MR scanning.
MRI TracerDrug
Also called Gadolinium-Based Contrast Agent (GBCA)
Injected via intravenous catheter during PET-MR scanning.
3T PET/MRIDevice
Used to evaluate neuroinflammation and cerebrovascular measures. Some MRI image acquisitions will employ work in progress (WIP) sequences, including ASL (Arterial Spin Labeling), Diffusion and T2-weighted EPI (DT2W), Golden-angle radial sparse parallel (GRASP) DCE-MRI, and Magnetization Transfer (MT) imaging.
| Study group | Role | What they receive |
|---|---|---|
| NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2) | Individuals with new onset a) cognitive and/or b) psychiatric symptoms following SARS-CoV-2 infection. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample. Receives: Drug: PET Tracer; Drug: MRI Tracer; Device: 3T PET/MRI | |
| CC (COVID Control) | Individuals with a history of SARS-CoV-2 infection who do not meet the criteria for any DSM-5 diagnosis and perform within normal limits on cognitive tests. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample. Receives: Drug: PET Tracer; Drug: MRI Tracer; Device: 3T PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Translocator Protein (TSPO)
Binding of PET tracer to TSPO.
Measured: PET/MR Visit (Day 1)
Occurrence of Microhemorrhages
Evaluated using MRI images (Susceptibility Weighted MRI (SWI), Fluid Attenuated Inversion Recovery (FLAIR), Diffusion Weighted Imaging (DWI), and anatomical MRI).
Measured: PET/MR Visit (Day 1)
Permeability Surface Area Product (PS)
Used to evaluate disruptions in the blood-brain-barrier. Derived from the DCE-MRI.
Measured: PET/MR Visit (Day 1)
Cerebral Blood Flow
Evaluated using cerebral blood flow maps from Arterial Spin Labeling (ASL).
Measured: PET/MR Visit (Day 1)
Peripheral Levels of Pro-Inflammatory Cytokines
Evaluated using blood samples.
Measured: PET/MR Visit (Day 1)
Peripheral Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Evaluated using blood samples.
Measured: PET/MR Visit (Day 1)
CSF Levels of Pro-Inflammatory Cytokines
Evaluated using cerebrospinal fluid collection (optional procedure).
Measured: CSF Visit (Screening) (Optional)
CSF Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Evaluated using cerebrospinal fluid collection (optional procedure).
Measured: CSF Visit (Screening) (Optional)
Free Diffusing Water Fraction
Calculated using DWI.
Measured: PET/MR Visit (Day 1)
Extra-Axonal Water Fraction
Calculated using DWI.
Measured: PET/MR Visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Baete, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615415
- Sponsor's protocol ID
- 21-00945
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Steven.baete@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Immunological and Vascular Dysfunction in Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO PET and MRI
- ClinicalTrials.gov ID
- NCT05615415
- Acronym / sponsor ID
- 21-00945
- Keywords
- Long COVID, COVID-19, Cognitive Deficit Following COVID-19, Depression and Anxiety following COVID-19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this study is to develop PET/MR techniques for the diagnosis of neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate neuropsychiatric PASC (NP-PASC).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2) | – | Drug: PET Tracer, Drug: MRI Tracer, Device: 3T PET/MRIIndividuals with new onset a) cognitive and/or b) psychiatric symptoms following SARS-CoV-2 infection. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample. |
| CC (COVID Control) | – | Drug: PET Tracer, Drug: MRI Tracer, Device: 3T PET/MRIIndividuals with a history of SARS-CoV-2 infection who do not meet the criteria for any DSM-5 diagnosis and perform within normal limits on cognitive tests. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET TracerAlso: C11-ER176Standard radiopharmaceutical injected via intravenous catheter during PET-MR scanning. | Drug | CC (COVID Control), NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2) |
| MRI TracerAlso: Gadolinium-Based Contrast Agent (GBCA)Injected via intravenous catheter during PET-MR scanning. | Drug | CC (COVID Control), NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2) |
| 3T PET/MRIUsed to evaluate neuroinflammation and cerebrovascular measures. Some MRI image acquisitions will employ work in progress (WIP) sequences, including ASL (Arterial Spin Labeling), Diffusion and T2-weighted EPI (DT2W), Golden-angle radial sparse parallel (GRASP) DCE-MRI, and Magnetization Transfer (MT) imaging. | Device | CC (COVID Control), NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2) |
Primary outcome
Level of Translocator Protein (TSPO)
Time frame: PET/MR Visit (Day 1)
Binding of PET tracer to TSPO.
Occurrence of Microhemorrhages
Time frame: PET/MR Visit (Day 1)
Evaluated using MRI images (Susceptibility Weighted MRI (SWI), Fluid Attenuated Inversion Recovery (FLAIR), Diffusion Weighted Imaging (DWI), and anatomical MRI).
Permeability Surface Area Product (PS)
Time frame: PET/MR Visit (Day 1)
Used to evaluate disruptions in the blood-brain-barrier. Derived from the DCE-MRI.
Cerebral Blood Flow
Time frame: PET/MR Visit (Day 1)
Evaluated using cerebral blood flow maps from Arterial Spin Labeling (ASL).
Peripheral Levels of Pro-Inflammatory Cytokines
Time frame: PET/MR Visit (Day 1)
Evaluated using blood samples.
Peripheral Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Time frame: PET/MR Visit (Day 1)
Evaluated using blood samples.
CSF Levels of Pro-Inflammatory Cytokines
Time frame: CSF Visit (Screening) (Optional)
Evaluated using cerebrospinal fluid collection (optional procedure).
CSF Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Time frame: CSF Visit (Screening) (Optional)
Evaluated using cerebrospinal fluid collection (optional procedure).
Free Diffusing Water Fraction
Time frame: PET/MR Visit (Day 1)
Calculated using DWI.
Extra-Axonal Water Fraction
Time frame: PET/MR Visit (Day 1)
Calculated using DWI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Steven.baete@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Baete principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Translocator Protein (TSPO) (time frame: PET/MR Visit (Day 1)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.