Evaluating a new imaging method for Long COVID-19

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.

This study is testing a new imaging method to see if it can help understand brain changes in people with Long COVID compared to those who have fully recovered.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06223971 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of a novel radiotracer called [11C]CPPC in patients with a history of COVID-19 infection. Participants will undergo positron emission tomography (PET) imaging to identify potential differences in brain structures between those experiencing Long COVID symptoms and those who are symptom-free. The study will also include cognitive testing and neurological exams to explore associations between COVID-19 infection and cognitive function. Ultimately, the goal is to improve understanding and management of Long COVID symptoms through enhanced imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented history of COVID-19 infection at least 6-12 months prior to enrollment.

Not a fit: Patients who do not have a history of COVID-19 infection or those who are not experiencing any symptoms related to Long COVID may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnostic imaging for patients suffering from Long COVID, potentially improving their treatment and care.

How similar studies have performed: While this approach is novel in the context of Long COVID, similar imaging techniques have shown promise in other neurological conditions.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Documented history of COVID infection at least 6 - 12 months before enrollment.
3. Men and women at least 18 years old.
4. 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).
5. Geographic accessibility to the study center and the ability to travel to the clinic for study visits.
6. Agrees to the visit schedule as outlined in the informed consent.
7. Pre-study labs within normal range, or if abnormal, deemed not clinically significant by the site investigator.

Exclusion Criteria:

1. History of recent nosocomial infection.
2. History of chronic neurological disorder, such as epilepsy, or structural Central Nervous System (CNS) abnormality such as stroke or arteriovenous malformation.
3. 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.
4. Active or recent (in the past year) substance dependence (drugs-including nicotine, marijuana or alcohol).
5. Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.
6. Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines within 7 days of administration of study compound.
7. Any concomitant medical disease or condition limiting the safety to participate including, but not limited to:

   * Coagulopathy
   * Active infection
8. Contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
9. Contraindications to PET scanning to include pregnancy, etc.
10. Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
11. Any radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
12. Any history of learning disability or special education (due to the potential to affect performance on neuropsychological testing).

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Licia Luna, M.D., Ph.D. — Johns Hopkins University
• Study coordinator: Mehreen Nabi, MBBS

Conditions COVID Long-Haul