An observational study in Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension and Urinary Tract Infections in Children, sponsored by Duke University. Recruiting at 52 sites in 2 countries. Open to participants aged 0 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Duke University · Observational
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Coronavirus Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children under 21 years of age.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
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.
Also known as: 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, Albuterol, Beclomethasone, Bivalirudin, Bumetanide, Cephalexin, Chlorothiazide, Clonidine, Dapagliflozin, Diazoxide, Drug-Drug Interaction Combinations, Fluticasone, Ganciclovir, Hydralazine, Hydrochlorothiazide, Valganciclovir
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.
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Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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