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

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 20 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how drugs given as part of usual care act in the bodies of children and young adults under age 21. It aims to help find the safest and most effective doses for children. People may qualify if they take a study drug or recently tested positive for the virus that causes COVID-19.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are younger than 21.
  • You, your parent, or your legal guardian can understand and agree to study consent and health privacy permission.
  • You are taking at least one study drug when you join, OR you are not taking a study drug but tested positive for the virus that causes COVID-19 within the past 60 days.

Who can't join

  • You are known to be pregnant. The other exclusions below apply only to people receiving study drugs.
  • You had intermittent dialysis (blood cleaning done at set times) in the past 24 hours.
  • You had a kidney transplant in the past 30 days.
  • You had a liver or stem cell transplant in the past year.
  • You had treatment to lower your body temperature in the past 24 hours.
  • You had plasmapheresis (a treatment that removes and replaces the liquid part of blood) in the past 24 hours.
  • You have a ventricular assist device (a pump that helps your heart move blood).
  • The study doctor thinks a health condition makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (50)

AR

AZ

CA

CO

DE

FL

HI

IA

IL

IN

KS

KY

LA

MA

MD

MN

MO

MS

NC

NE

NH

NM

OH

OK

OR

PA

RI

SC

SD

TN

TX

UT

WA

WI

WV