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

Study Overview
=================
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 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.

Official Title
-----------------
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Conditions
-----------------
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, 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

Intervention / Treatment
-----------------
* 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:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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, 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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and young adults who are prescribed drugs of interest<br>Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive. | 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:<br>* The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.<br>* Other names: Sarilumab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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. |