COVID Long-HaulEarly Phase 1NCT06223971

Long COVID-19 [11C]CPPC Study

A Early Phase 1 study testing [11C]CPPC Injection in people with COVID Long-Haul, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID Long-Haul
What is being tested?: [11C]CPPC Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 6 Aug 2024to 31 Mar 2026
Phase: Early Phase 1
Are there results?: None posted in the registry

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.
Documented history of COVID infection at least 6 - 12 months before enrollment.
Men and women at least 18 years old.
Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy, oophorectomy or surgical sterilization).
Geographic accessibility to the study center and the ability to travel to the clinic for study visits.
Agrees to the visit schedule as outlined in the informed consent.
Pre-study labs within normal range, or if abnormal, deemed not clinically significant by the site investigator.

Who cannot join

History of recent nosocomial infection.
History of chronic neurological disorder, such as epilepsy, or structural Central Nervous System (CNS) abnormality such as stroke or arteriovenous malformation.
History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition including stroke, seizure (excluding childhood febrile seizure), or visible structural abnormality on prior MRI.
Active or recent (in the past year) substance dependence (drugs-including nicotine, marijuana or alcohol).
Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.
Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines within 7 days of administration of study compound.

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Any concomitant medical disease or condition limiting the safety to participate including, but not limited to:
Coagulopathy
Active infection
Contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
Contraindications to PET scanning to include pregnancy, etc.
Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
Any radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
Any history of learning disability or special education (due to the potential to affect performance on neuropsychological testing).

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Phase l Study to Assess the Safety and Tolerability of PET Imaging With [11 C]CPPC [5-cyano-N-( 4-( 4-[l l CJ me1hylpiperazin-l-yl)-2-(Piperidin-l-yl)Phenyl)Furan-2-carboxamide] Radioligand and Magnetic Resonance (MR) Imaging in Patients With Long COVID.

The goal of this study is to evaluate the safety of using the [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] ([11C]CPPC) radiotracer in positron emission tomography (PET) imaging of people with history of COVID-19 infection, with and without symptoms. The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with history of COVID-19 infection and still exhibiting symptoms or healthy patients with history of COVID-19 infection but exhibiting no current symptoms.

Read the detailed description

This is a Phase 1 study of safety and tolerability of an investigational radiotracer drug called [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] ([11C]CPPC). A radiotracer is a substance that chemically marks certain structures in the body. In this case, [11C]CPPC highlights structures expressing colony stimulating factor receptor (CSF1R), a receptor that is expressed on microglial cells. A safety and tolerability study is looking to see if there are any unanticipated, possibly harmful, effects of the use of the radiotracer in humans. However, ultimately, the investigators would like to know if this drug can be used to make better images of the brain for patients with history of COVID-19 infection, which could help doctors better understand the disease and help take care of patients suffering from Long COVID symptoms. This study will use a radiotracer to look for a chemical receptor which may be affected in patients who report of Long COVID. After receiving the radiotracer, participants' brains will be scanned with a positron emission tomography (PET) imaging machine. Each participant will also undergo magnetic resonance imaging (MRI) without contrast, detailed cognitive testing and a neurological exam. This study will assess possible associations between COVID-19 infection, cognitive function, other neurological symptoms, and 11C-CPPC PET neuroimaging in subjects.

Conditions: COVID Long-Haul
Being tested: [11C]CPPC Injection
Medical subject headings: Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[11C]CPPC InjectionDrug
A single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.
Other Name: [5-cyano-N-(4-(4-[11C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide]
[11C]CPPC InjectionDrug
A single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.
Other Name: [5-cyano-N-(4-(4-[11C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide]

Study groups in NCT06223971
Study group	Role	What they receive
Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)	Experimental	Participants with a diagnosis of Long- COVID will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan. Receives: Drug: [11C]CPPC Injection
Healthy Participants with history of COVID-19 infection but not experiencing any symptoms.	Experimental	Healthy participants (without any history of post-COVID symptoms) will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan. Receives: Drug: [11C]CPPC Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.
Safety and tolerability will be determined by evaluation of spontaneously reported adverse events, clinical laboratory test results, physical, cognitive and neurologic exams and imaging (PET).
Measured: Baseline and up to 2 days follow-up after scan
Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete blood count (CBC) test.
Safety of use of [11C]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-Covid and healthy participants with history of COVID-19 infection. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range.
Measured: Baseline and up to 2 days follow-up after scan
Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete metabolic panel (CMP) test.
Safety of use of [11C]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-COVID and healthy participants with history of COVID-19 infection. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range
Measured: Baseline and up to 2 days follow-up after scan

Secondary outcomes (6)

Biodistribution of [11C]CPPC by PET imaging
Image analysis of PET imaging obtained of patients and healthy participants. The PET compartmental model fits will be applied to the regional time activity curves (TACs) will be first assessed visually before the relative goodness of fit will be assessed using the statistical F test.
Measured: 1 day
Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)
NIH Toolbox Cognition Battery (NIHTB-CB), which is an iPad-based instrument assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. Score range 59 - 140, higher score means better cognition.
Measured: 1 day
Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)
The Rey-Osterrieth complex figure test (ROCF) is a neuro-psychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the 36-point scoring system (0 being the worst score and 36 the best).
Measured: 1 day
Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)
The MMSE is a measure of global cognitive function, scores range from 0-30, a lower score indicates greater cognitive impairment.
Measured: 1 day
Dementia as assessed by the Clinical Dementia Rating (CDR) scale
The Clinical Dementia Rating Dementia Staging Instrument minimum score = 0, maximum score = 18. Low scores indicate less problems.
Measured: 1 day
Hospital Anxiety and Depression Scale (HADS) score
Scoring for the Hospital Anxiety and Depression scale is 0-21; Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21) higher score indicates worse outcome.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 202431 Mar 2026

First posted25 Jan 2024
Study start6 Aug 2024
Primary completion30 Apr 2025
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID Long-HaulStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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: Early Phase 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06223971
Sponsor's protocol ID: IRB00361674
Status last verified: Apr 2026
First submitted: 23 Jan 2024
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID Long-Haul trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase l Study to Assess the Safety and Tolerability of PET Imaging With [11 C]CPPC [5-cyano-N-( 4-( 4-[l l CJ me1hylpiperazin-l-yl)-2-(Piperidin-l-yl)Phenyl)Furan-2-carboxamide] Radioligand and Magnetic Resonance (MR) Imaging in Patients With Long COVID.
ClinicalTrials.gov ID: NCT06223971
Acronym / sponsor ID: IRB00361674
Conditions: COVID Long-Haul
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Radiological Society of North America
Study start: 6 Aug 2024 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 25 Jan 2024 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)	Experimental	Drug: [11C]CPPC InjectionParticipants with a diagnosis of Long- COVID will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.
Healthy Participants with history of COVID-19 infection but not experiencing any symptoms.	Experimental	Drug: [11C]CPPC InjectionHealthy participants (without any history of post-COVID symptoms) will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.
Documented history of COVID infection at least 6 - 12 months before enrollment.
Men and women at least 18 years old.
Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy, oophorectomy or surgical sterilization).
Geographic accessibility to the study center and the ability to travel to the clinic for study visits.

Key exclusion criteria (14 listed)

History of recent nosocomial infection.
History of chronic neurological disorder, such as epilepsy, or structural Central Nervous System (CNS) abnormality such as stroke or arteriovenous malformation.
History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition including stroke, seizure (excluding childhood febrile seizure), or visible structural abnormality on prior MRI.
Active or recent (in the past year) substance dependence (drugs-including nicotine, marijuana or alcohol).
Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.

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]CPPC InjectionA single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan. Other Name: [5-cyano-N-(4-(4-[11C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide]	Drug	Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)
[11C]CPPC InjectionA single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan. Other Name: [5-cyano-N-(4-(4-[11C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide]	Drug	Healthy Participants with history of COVID-19 infection but not experiencing any symptoms.

Primary outcome

To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.
Time frame: Baseline and up to 2 days follow-up after scan
Safety and tolerability will be determined by evaluation of spontaneously reported adverse events, clinical laboratory test results, physical, cognitive and neurologic exams and imaging (PET).
Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete blood count (CBC) test.
Time frame: Baseline and up to 2 days follow-up after scan
Safety of use of [11C]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-Covid and healthy participants with history of COVID-19 infection. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range.
Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete metabolic panel (CMP) test.
Time frame: Baseline and up to 2 days follow-up after scan
Safety of use of [11C]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-COVID and healthy participants with history of COVID-19 infection. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range

6 secondary outcomes

Biodistribution of [11C]CPPC by PET imaging
Time frame: 1 day
Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)
Time frame: 1 day
Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)
Time frame: 1 day
Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)
Time frame: 1 day
Dementia as assessed by the Clinical Dementia Rating (CDR) scale
Time frame: 1 day
Hospital Anxiety and Depression Scale (HADS) score
Time frame: 1 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Individual participant dataSharing planned: No

Related trials for COVID Long-Haul

Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
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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.

Licia Luna, M.D., Ph.D. principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [11C]CPPC Injection in people with COVID Long-Haul, run by Johns Hopkins University 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 30 Apr 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously. (time frame: Baseline and up to 2 days follow-up after scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223971.

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 Apr 2026.