Long COVIDPhase 1NCT06920628
PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
A Phase 1 study testing 11C-PS13 in people with Long COVID and Post Acute Sequelae of COVID-19, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Post Acute Sequelae of COVID-19
- What is being tested?
- 11C-PS13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 22 Feb 2029
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria:
- Aged 18 to 70 years of age.
- Participants must be in good general health as evidenced by medical history and physical examination.
- Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Participants must have undergone a screening assessment under protocol #000089, Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health or #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC.
- Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
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- Participants must agree to adhere to the lifestyle considerations.
- Healthy Volunteers: To be eligible to participate in this study, healthy volunteers must meet all of the following criteria:
- Aged 18 to 70 years of age.
- Able to provide informed consent.
- Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.
- Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing.
- Participants must be at least six weeks out since the onset of SARS-CoV-2 symptoms with no fever for at least one week.
- Participants must report having at least one prior SARS-CoV-2 infection.
- Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Agree to adhere to the lifestyle considerations.
Who cannot join
- Participants with Neuro-PASC who meet any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing based on individual clinical judgement. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two times the upper limit or lower values, as per the investigator s judgment. Creatinine level >1.3 mg/dL.
- Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to each PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken within one month prior to each PET scan.
- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.
- Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
- Are unable to travel to the NIH.
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- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits as determined by the study team.
- Have an inability to lie flat and/or lie still on the camera bed for at least two hours,including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Pregnancy or Breastfeeding Women.
- HIV Infection.
- Healthy volunteers who meet any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Participants should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for two weeks prior to the PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g., methotrexate) must not have been taken within one month prior to the PET scan.
- Participants with an active SARS-CoV-2 infection.
- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.
- Are unable to travel to the NIH.
- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
- Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Pregnancy or Breastfeeding Women.
- HIV Infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders.
Read more
Objective:
To see if a radioactive tracer ([11C]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.
Eligibility:
Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed.
Design:
Participants will have up to 5 clinic visits.
Participants will be screened. They will have blood tests and a test of their heart function.
They will have imaging scans:
Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain.
Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours.
Study involvement is 11 to 14 weeks....
Read the detailed description
Study Description:
This study will examine whether cyclooxygenase-1 (COX-1), a biomarker of neuroinflammation, is elevated in the brains of individuals with neurological manifestations of Post-Acute Sequelae of SARS-CoV-2 infection (Neuro-PASC).
Objectives:
Primary Objective 1: To determine whether COX-1 is elevated in the striatum of individuals with Neuro-PASC compared to an ageand sex-matched group of healthy volunteers.
Primary Objective 2: To assess the effect of IVIg treatment on Neuro-PASC participants.
Secondary Objective 1: To determine if COX-1 is elevated in all brain regions of individuals with Neuro-PASC compared to healthy volunteers.
Secondary Objective 2: To determine the correlation between COX-1 expression in the striatum of Neuro-PASC participants and three variables: a) plasma CRP levels as an overall measure of inflammation, b) speed on the finger-tapping test, and c) clinical improvement.
Endpoints:
Primary endpoints:
- COX-1 binding in the striatal region (i.e., caudate plus putamen) will be quantified using pharmacokinetic modeling to compare striatal COX-1 in the Neuro-PASC participants to healthy volunteers
- Neuro-PASC participants will be separated into responders and non-responders to the IVIg treatment and scanned a second time to assess COX-1 expression.
Secondary endpoints:
- Comparison of the whole brain COX-1 densities at the voxel level between the Neuro-PASC participants and healthy volunteers.
- COX-1 striatal expression relation to Neuro-PASC participants plasma CRP levels, speed on the finger-tapping test, and clinical improvement.
- Conditions
- Long COVID, Post Acute Sequelae of COVID-19
- Being tested
- 11C-PS13
- Keywords
- Inflammation, COVID, SARS, Neuro-PASC
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-PS13Drug
Injected IV followed by PET scanning.
| Study group | Role | What they receive |
|---|---|---|
| one arm | Other | All subjects will receive the same tests Receives: Drug: 11C-PS13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure distribution volume for 11C-PS13
Target quantification of COX-1
Measured: 36 months
Secondary outcomes (4)
Voxel-wise correlation of distribution volume between healthy volunteers and Neuro-PASC participants
Comparing between COX-1 in healthy volunteers and participants on voxel-level
Measured: 36 months
Correlation of Distribution Volume with CRP
To determine if CRP correlates with COX-1
Measured: 36 months
Correlation of Distribution Volume with Finger Tapping Speed
To determine if Finger-tapping correlates with COX-1
Measured: 36 months
Correlation of Distribution Volume with Clinical Improvement
To determine if Clinical Improvement correlates with COX-1
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start18 Jun 2025
- Primary completion22 Feb 2028 (estimated)
- Study completion22 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920628
- Sponsor's protocol ID
- 10002117
- Other IDs
- 002117-M
- Status last verified
- 14 Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be submitted to ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
- ClinicalTrials.gov ID
- NCT06920628
- Acronym / sponsor ID
- 10002117
- Conditions
- Long COVID, Post Acute Sequelae of COVID-19
- Keywords
- Inflammation, COVID, SARS, Neuro-PASC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 22 Feb 2029 (estimated)
- First posted
- 10 Apr 2025 (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.
Background:
SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders.
Objective:
To see if a radioactive tracer ([11C]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.
Eligibility:
Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed.
Design:
Participants will have up to 5 clinic visits.
Participants will be screened. They will have blood tests and a test of their heart function.
They will have imaging scans:
Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain.
Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours.
Study involvement is 11 to 14 weeks....
Detailed description
Study Description:
This study will examine whether cyclooxygenase-1 (COX-1), a biomarker of neuroinflammation, is elevated in the brains of individuals with neurological manifestations of Post-Acute Sequelae of SARS-CoV-2 infection (Neuro-PASC).
Objectives:
Primary Objective 1: To determine whether COX-1 is elevated in the striatum of individuals with Neuro-PASC compared to an ageand sex-matched group of healthy volunteers.
Primary Objective 2: To assess the effect of IVIg treatment on Neuro-PASC participants.
Secondary Objective 1: To determine if COX-1 is elevated in all brain regions of individuals with Neuro-PASC compared to healthy volunteers.
Secondary Objective 2: To determine the correlation between COX-1 expression in the striatum of Neuro-PASC participants and three variables: a) plasma CRP levels as an overall measure of inflammation, b) speed on the finger-tapping test, and c) clinical improvement.
Endpoints:
Primary endpoints:
- COX-1 binding in the striatal region (i.e., caudate plus putamen) will be quantified using pharmacokinetic modeling to compare striatal COX-1 in the Neuro-PASC participants to healthy volunteers
- Neuro-PASC participants will be separated into responders and non-responders to the IVIg treatment and scanned a second time to assess COX-1 expression.
Secondary endpoints:
- Comparison of the whole brain COX-1 densities at the voxel level between the Neuro-PASC participants and healthy volunteers.
- COX-1 striatal expression relation to Neuro-PASC participants plasma CRP levels, speed on the finger-tapping test, and clinical improvement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | Other | Drug: 11C-PS13All subjects will receive the same tests |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria:
- Aged 18 to 70 years of age.
- Participants must be in good general health as evidenced by medical history and physical examination.
- Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Participants must have undergone a screening assessment under protocol #000089, Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health or #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC.
Key exclusion criteria (22 listed)
- Participants with Neuro-PASC who meet any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing based on individual clinical judgement. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two times the upper limit or lower values, as per the investigator s judgment. Creatinine level >1.3 mg/dL.
- Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to each PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken within one month prior to each PET scan.
- Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.
- Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
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 |
|---|---|---|
| 11C-PS13Injected IV followed by PET scanning. | Drug | one arm |
Primary outcome
To measure distribution volume for 11C-PS13
Time frame: 36 months
Target quantification of COX-1
4 secondary outcomes
Voxel-wise correlation of distribution volume between healthy volunteers and Neuro-PASC participants
Time frame: 36 months
Correlation of Distribution Volume with CRP
Time frame: 36 months
Correlation of Distribution Volume with Finger Tapping Speed
Time frame: 36 months
Correlation of Distribution Volume with Clinical Improvement
Time frame: 36 months
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 18 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results will be submitted to ClinicalTrials.gov
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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.
Robert B Innis, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11C-PS13 in people with Long COVID and Post Acute Sequelae of COVID-19, run by National Institute of Mental Health (NIMH) 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 17 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 18 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Tara N Turon, C.R.N.P. ((301) 827-6599, tara.turon@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure distribution volume for 11C-PS13 (time frame: 36 months). 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 18 Aug 2026.