Search / Trial NCT06223971

Long COVID-19 [11C]CPPC Study

Launched by JOHNS HOPKINS UNIVERSITY · Jan 23, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

The Long COVID-19 [11C]CPPC Study is a clinical trial designed to explore the safety of a special imaging substance called [11C]CPPC in patients who have had COVID-19. This study aims to see if this imaging can help identify differences between people who are still experiencing symptoms from their COVID-19 infection and those who have fully recovered and show no symptoms. Researchers hope that this will provide better understanding and insights into the long-lasting effects of COVID-19, often referred to as "Long COVID."

To participate in this study, you need to be at least 18 years old and have a documented history of COVID-19 infection at least 6 to 12 months before joining. You should also be able to provide informed consent, meaning you understand the study and agree to take part. Participants will need to visit the study clinic for certain appointments and undergo imaging tests. It’s important to note that some people may not qualify due to certain medical conditions or recent treatments. If you’re interested in learning more or think you might be eligible, it's a good idea to reach out to the study team for further information.

Gender

ALL

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).

Trial Officials

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

Principal Investigator

Johns Hopkins University

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0