ACTIVE_NOT_RECRUITING

Long COVID-19 [11C]CPPC Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-08-06

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06223971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Licia Luna, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-08-06

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

COVID Long-Haul