Long COVID-19 [11C]CPPC Study (NCT06223971) | Clinical Trial Compass
CompletedEarly Phase 1
Long COVID-19 [11C]CPPC Study
United States6 participantsStarted 2024-08-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.
Timeframe: Baseline and up to 2 days follow-up after scan
2
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.
Timeframe: Baseline and up to 2 days follow-up after scan
3
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.
Timeframe: Baseline and up to 2 days follow-up after scan