Status:
RECRUITING
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Lead Sponsor:
Duke University
Collaborating Sponsors:
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Eligibility:
All Genders
Up to 20 years
Brief Summary
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the m...
Eligibility Criteria
Inclusion
- Participant is \< 21 years of age
- Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
- (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
- 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)
- Has had intermittent dialysis within previous 24 hours
- Has had a kidney transplant within previous 30 days
- Has had a liver transplant within previous 1 year
- Has had a stem cell transplant within previous 1 year
- Has had therapeutic hypothermia within previous 24 hours
- Has had plasmapheresis within the previous 24 hours
- Has a Ventricular Assist Device
- Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Key Trial Info
Start Date :
March 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04278404
Start Date
March 5 2020
End Date
September 1 2027
Last Update
March 12 2025
Active Locations (51)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
4
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304