The study investigators are interested in learning more about how drugs, that are givento children by their health care provider, act in the bodies of children and young adultsin hopes to find the most safe and effective dose for children. The primary objective ofthis study is to evaluate the PK of understudied drugs currently being administered tochildren per SOC as prescribed by their treating provider.
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 Name: 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,Abatacept,Infliximab
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
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of California, Los Angeles Medical Center
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Colorado University Denver
Aurora, Colorado, United States
The Children's Hospital Colorado
Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida, United States
Kapiolani Womens and Childrens Medical Center
Honolulu, Hawaii, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States
University of Kansas Medical Center-JG Kidney Institute
Kansas City, Kansas, United States
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States
Tulane University Health Science Center
New Orleans, Louisiana, United States
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Lexington, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Pennsylvania State University--Hershey Children's Hospital
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
University of South Carolina
Columbia, South Carolina, United States
Avera McKennan Hospital & University Medical Center
Sioux Falls, South Dakota, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas-Southwestern Medical Center Dallas
Dallas, Texas, United States
University of Texas--Memorial Hermann Texas Medical Center
Houston, Texas, United States
The Womens Hospital of Texas
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University Wisconsin Madison
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte-Justine
Montréal, Quebec, Canada
Chi Hornik
(919) 260-7626
chi.hornik@duke.edu
Jerry Kirchner
(919) 812-1798
jerry.kirchner@duke.edu
Chi Hornik, Principal Investigator
Duke Clinical Research Institute