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Understanding how drugs work in children

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Duke University · NCT04278404

This study is trying to find the best and safest doses of certain medications for children and young adults under 21 who are being treated for conditions like COVID-19 and pulmonary arterial hypertension.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages0 Years to 20 Years
SexAll
SponsorDuke University (other)
Locations51 sites (Phoenix, Arizona and 50 other locations)
Trial IDNCT04278404 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 21 years old who are receiving specific drugs or have had a recent COVID-19 infection.

Not a fit: Patients who are pregnant or have had recent organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective drug dosing for children.

How similar studies have performed: Other studies have shown promise in understanding drug effects in pediatric populations, but this specific approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coronavirus Infection, Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.