Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Launched by DUKE UNIVERSITY · Feb 18, 2020

Keywords

ClinConnect Summary

**Trial Summary: POPS Study on Drug Safety and Effectiveness in Children**

The POPS study is looking at how different medications work in children and young adults, particularly those that are not well-studied yet. The goal is to understand how these drugs act in the body to find the safest and most effective dosages for younger patients. The study is open to children under 21 years old who are either currently receiving one of the medications being studied or have tested positive for COVID-19 in the last 60 days.

If you or your child participates, you can expect to provide some information about their health and receive a thorough explanation of the study. This is important because it helps researchers learn how these drugs perform in children, which can lead to better treatment options in the future. It's worth noting that there are some conditions that may exclude participation, such as being pregnant or having had certain medical procedures recently. Your child's safety is a top priority throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is \< 21 years of age
• 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• • 3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
• Exclusion Criteria:
• • 1. Participant has a known pregnancy
• Below exclusion criteria apply only to:
• • Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
• • 2. Has had intermittent dialysis within previous 24 hours
• • 3. Has had a kidney transplant within previous 30 days
• • 4. Has had a liver transplant within previous 1 year
• • 5. Has had a stem cell transplant within previous 1 year
• • 6. Has had therapeutic hypothermia within previous 24 hours
• • 7. Has had plasmapheresis within the previous 24 hours
• • 8. Has a Ventricular Assist Device
• • 9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study