|February 18, 2020
|February 20, 2020
|October 14, 2020
|March 5, 2020
|April 24, 2024 (Final data collection date for primary outcome measure)
- Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Elimination rate constant (ke) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Half-life (t1/2) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Absorption rate constant (ka) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- AUC (area under the curve) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Maximum concentration (Cmax) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
- Time to achieve maximum concentration (Tmax) as measured by PK sampling [ Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. ]
|Same as current
|Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
|Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
|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 most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
|Observational Model: Other
Time Perspective: Prospective
|Retention: Samples With DNA
Whole blood, effluent samples, and plasma.
|Children under 21 years of age.
- Coronavirus Infection (COVID-19)
- Pulmonary Arterial Hypertension
- Urinary Tract Infections in Children
- Primary Hyperaldosteronism
- Heart Failure
- Skin Infection
- Asthma in Children
- Bronchopulmonary Dysplasia
- Adrenal Insufficiency
- Fibrinolysis; Hemorrhage
- Attention Deficit Hyperactivity Disorder
- Multisystem Inflammatory Syndrome in Children (MIS-C)
- Kawasaki Disease
- Coagulation Disorder
- Down Syndrome
|Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
- Aminocaproic acid
- Sevelamer Carbonate / Sevelamer Hydrochloride
- Tranexamic acid
|Children and young adults who are prescribed drugs of interest
Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
Intervention: Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
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|Same as current
|April 24, 2024
|April 24, 2024 (Final data collection date for primary outcome measure)
Participant is < 21 years of age and
- is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR
is NOT receiving one or more of the study drugs of interest but is SARS-CoV-2 positive within 60 days prior to enrollment
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA
Participant has a known pregnancy
For 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)
- 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
|Sexes Eligible for Study:
|up to 20 Years (Child, Adult)
|Canada, United States
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
- The Emmes Company, LLC
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
||Duke Clinical Research Institute