Understanding how drugs work in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the pharmacokinetics and pharmacodynamics of understudied drugs administered to children under standard care. By collecting bodily fluid samples from participants, the study seeks to determine the most effective and safe dosages for various conditions, including COVID-19 and pulmonary arterial hypertension. The research focuses on children and young adults under 21 years of age who are either currently receiving these drugs or have recently tested positive for SARS-CoV-2. The findings could help optimize treatment protocols for pediatric patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Lucile Packard Children's Hospital
  Palo Alto, California, United States Recruiting
• Duke University Health System
  Durham, North Carolina, United States Recruiting
• Cincinnati Childrens Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Dell Children's Medical Center of Central Texas
  Austin, Texas, United States Recruiting
• CHU Sainte-Justine
  Montreal, Quebec, Canada Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Completed

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Chi Hornik — Duke Clinical Research Institute
• Study coordinator: Chi Hornik
• Email: chi.hornik@duke.edu
• Phone: (919) 260-7626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.