NCT06223971

Long COVID-19 [11C]CPPC Study

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.

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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

Interventions

Type	Name	Description
DRUG	[11C]CPPC Injection	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\]
DRUG	[11C]CPPC Injection	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\]

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-04-30
• Completion: 2026-03-31
• First posted: 2024-01-25
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study