[11C]CPPC Injection for Long COVID

Recruiting in Palo Alto (17 mi)

Overseen by Licia Luna, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Anti-inflammatories, Immunosuppressants, Benzodiazepines

Disqualifiers: Neurological disorders, Substance dependence, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using anti-inflammatory medications, immunosuppressants, or benzodiazepines at least 7 days before participating. If you are taking any of these, you will need to stop them temporarily.

What data supports the effectiveness of the drug [11C]CPPC for Long COVID?

The research does not provide direct evidence of [11C]CPPC's effectiveness for Long COVID, but it mentions that [11C]CPPC is a radioligand for imaging neuroinflammation, which could be relevant since inflammation is a component of Long COVID. ^{1 2 3 4 5}

Is [11C]CPPC safe for human use?

The [11C]CPPC injection is formulated as a sterile, pyrogen-free solution suitable for human injection, meeting current Good Manufacturing Practice (cGMP) requirements, which suggests it is safe for human use. ^{1 3 4 6 7}

How does the drug [11C]CPPC differ from other treatments for Long COVID?

[11C]CPPC is unique because it is a PET radiotracer designed to image CSF1R, a marker specific to microglia (a type of immune cell in the brain), which may help in understanding and potentially treating Long COVID by targeting brain inflammation. This approach is different from standard treatments as it involves imaging and targeting specific brain cells rather than just addressing symptoms. ^{1 2 3 4 6}

Research Team

Licia Luna, M.D., Ph.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals who have had COVID-19. It's open to those with lingering symptoms (Long-COVID) and those without current symptoms. Participants must be suitable for PET scans using the [11C]CPPC radiotracer, but specific health requirements are not listed.

Inclusion Criteria

I had COVID-19 between 6 and 12 months ago.

Agrees to the visit schedule as outlined in the informed consent.

I am not pregnant and either use birth control, cannot have children, or have been menopausal for 2+ years.

Exclusion Criteria

I have a long-term brain condition like epilepsy or had a stroke.

I have had a severe head injury, stroke, seizures (except fever-related in childhood), or an abnormal brain scan.

Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of [11C]CPPC intravenously followed by PET and MRI scans

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in CMP and CBC tests

2 days

1 visit (in-person)

Treatment Details

Interventions

• [11C]CPPC (Radiotracer)

Trial Overview [11C]CPPC Injection is being tested in this study. The researchers want to see if it's safe and whether it shows differences in PET scan images between Long-COVID patients and recovered individuals without symptoms.

Participant Groups

Group I: Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID) Experimental Treatment 1 Intervention

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.

Group II: Healthy Participants with history of COVID-19 infection but not experiencing any symptoms. Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Findings from Research

The study identified 11C-L-methionine as the most effective amino acid for tumor detection, showing a high uptake in cancerous tissue with a tumor to blood ratio of 11.4, indicating its potential for accurate cancer diagnosis.

11C-DL-methyl-ACPC, a newly synthesized amino acid, also demonstrated significant tumor accumulation, with a tumor to liver ratio of 3.0, suggesting it could be a valuable tool for cancer imaging using positron emission tomography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor detection with carbon-11-labelled amino acids. Kubota, K., Yamada, K., Fukada, H., et al.[2019]

The copper-mediated radiocyanation method allows for the efficient and site-specific introduction of [11C]CN into peptides, even those with complex structures, while maintaining high radiochemical yields and minimizing side reactions.

This technique was successfully used to produce over 40 mCi of [11C]cyano-NOP, which demonstrated the ability of nociceptin to cross the blood-brain barrier and distribute throughout the brain, providing valuable insights for future research on NOP receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copper-Mediated Radiocyanation of Unprotected Amino Acids and Peptides. Sharninghausen, LS., Preshlock, S., Joy, ST., et al.[2023]

The study demonstrated that 11C-1-aminocyclopentane carboxylic acid (11C-ACPC) has a high affinity for malignant tumors, as shown by its significant uptake in VX-2 tumors in rabbits during positron emission tomography imaging.

Kinetic analysis revealed that while 11C-ACPC levels in plasma decreased rapidly post-injection, its concentration in the tumor increased over time, suggesting its potential for effective tumor detection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetic evaluation of 11C-1-aminocyclopentane carboxylic acid in rabbits bearing VX-2 tumors using positron emission tomography. Fujiwara, T., Matsuzawa, T., Kawai, H., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumor location with 1-aminocyclopentane [11C] carboxylic acid: preliminary clinical trials with single-photon detection. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Tumor detection with carbon-11-labelled amino acids. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Radiosynthesis and validation of [5-cyano-N-(4-(4-[11 C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl) furan-2-carboxamide] ([11 C]CPPC), a PET radiotracer for imaging CSF1R, a microglia-specific marker. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Carboxyl-labeled 11C-1-aminocyclopentanecarboxylic acid, a potential agent for cancer detection. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Discovery of a High-Affinity Fluoromethyl Analog of [11C]5-Cyano-N-(4-(4-methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide ([11C]CPPC) and Their Comparison in Mouse and Monkey as Colony-Stimulating Factor 1 Receptor Positron Emission Tomography Radioligands. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Copper-Mediated Radiocyanation of Unprotected Amino Acids and Peptides. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Kinetic evaluation of 11C-1-aminocyclopentane carboxylic acid in rabbits bearing VX-2 tumors using positron emission tomography. [2023]