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


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.


  • 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


Eligible Ages
Under 20 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. Participant is < 21 years of age and 1. is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR 2. 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

Exclusion Criteria

  1. 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) 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

Study Design

Study Type
Observational Model
Time Perspective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
    Other names:
    • Aminocaproic acid
    • Amiodarone
    • Bosentan
    • Budesonide
    • Cefdinir
    • Cefepime
    • Ceftazidime
    • Clindamycin
    • Clobazam
    • Dexamethasone
    • Dexmedetomidine
    • Dextroamphetamine/Amphetamine
    • Fosfomycin
    • Furosemide
    • Gabapentin
    • Guanfacine
    • Hydrocortisone
    • Labetalol
    • Meropenem
    • Metformin
    • Milrinone
    • Nalbuphine
    • Nicardipine
    • Nifedipine
    • Oseltamivir
    • Oxycodone
    • Risperidone
    • Sertraline
    • Sevelamer Carbonate / Sevelamer Hydrochloride
    • Spironolactone
    • Terbutaline
    • Tranexamic acid
    • Voriconazole
    • Zolpidem
    • Azithromycin
    • Lopinavir/Ritonavir
    • Ribavirin
    • Tocilizumab
    • Anakinra
    • Aspirin
    • Canakinumab
    • Colchicine
    • Interferon
    • Remdesivir
    • Ruxolitinib
    • Sarilumab

Recruiting Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Theresa Rogers

More Details

Duke University

Study Contact

Chi Hornik
(919) 260-7626