Long COVID-19 [11C]CPPC Study

NCT06223971 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB00361674
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID Long-Haul

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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

  Baseline and up to 2 days follow-up after scan

Secondary Outcomes (6)

• Biodistribution of [11C]CPPC by PET imaging

  1 day

• Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)

  1 day

• Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)

  1 day

• Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)

  1 day

• Dementia as assessed by the Clinical Dementia Rating (CDR) scale

  1 day

Study Arms (2)

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.

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.

Drug: [11C]CPPC Injection

Interventions

[11C]CPPC Injection DRUG

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\]

Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Radiological Society of North America: collaborator

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Licia Luna, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 25, 2024
• Study Start: August 6, 2024
• Primary Completion: April 30, 2025
• Study Completion: March 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)