Recruiting

Understudied Drugs

Sponsor:

Duke University

Code:

NCT04278404

Conditions

Coronavirus Infection (COVID-19)

Pulmonary Arterial Hypertension

Urinary Tract Infections in Children

Hypertension

Pain

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Accepted

Interventions

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:

Study Details

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.

Conditions

Coronavirus Infection (COVID-19)

Pulmonary Arterial Hypertension

Urinary Tract Infections in Children

Hypertension

Pain

Study ID

NCT04278404

Start date

Mar 5, 2020

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Chi Hornik

(919) 260-7626chi.hornik@duke.edu

Melissa James, MPH, RD

(704) 502-6491melissa.james@duke.edu

Locations

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Yasaman Nourkhala

650-724-4548yasinour@stanford.edu

Shelby Burk

650-704-2186shelbyb@stanford.edu

Principal Investigator:

Eunice Koh

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Melissa Harward

919-668-3910melissa.harward@dm.duke.edu

Bethany Kristler

919-681-2554bethany.kistler@duke.edu

Principal Investigator:

Chi Hornik

Cincinnati Childrens Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Kelli Krallman

513-636-4837kelli.krallman@cchmc.org

Michaela Collins

513-803-7340michaela.collins@cchmc.org

Principal Investigator:

Stuart Goldstein

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Michael Box

512-820-2136michael.box@ascension-external.org

Jeremy Kulwin

jeremy.kulwin@ascension-external.org

Principal Investigator:

Samantha Dallefeld

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Clothilde Gravel

514-345-4931clotilde.gravel.hsj@ssss.gouv.qc.ca

Vincent Lague

514-345-4931vincent.lague.hsj@ssss.gouv.qc.ca

Principal Investigator:

Julie Autmizguine

More Information

Sponsor

Duke University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.