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Trial record 8 of 8 for:    budesonide | Covid19

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278404
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date February 18, 2020
First Posted Date February 20, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date March 5, 2020
Estimated Primary Completion Date April 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2020)
  • 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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Official Title Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, effluent samples, and plasma.
Sampling Method Non-Probability Sample
Study Population Children under 21 years of age.
Condition
  • Coronavirus Infection (COVID-19)
  • Pulmonary Arterial Hypertension
  • Urinary Tract Infections in Children
  • Hypertension
  • Pain
  • Hyperphosphatemia
  • Primary Hyperaldosteronism
  • Edema
  • Hypokalemia
  • Heart Failure
  • Hemophilia
  • Menorrhagia
  • Insomnia
  • Pneumonia
  • Skin Infection
  • Arrythmia
  • Asthma in Children
  • Bronchopulmonary Dysplasia
  • Adrenal Insufficiency
  • Fibrinolysis; Hemorrhage
  • Attention Deficit Hyperactivity Disorder
  • Multisystem Inflammatory Syndrome in Children (MIS-C)
  • Kawasaki Disease
  • Coagulation Disorder
  • Down Syndrome
Intervention 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 Names:
  • 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
Study Groups/Cohorts 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.
Intervention: 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:
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 18, 2020)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 24, 2024
Estimated Primary Completion Date April 24, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Participant is < 21 years of age and

    1. is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR
    2. is NOT receiving one or more of the study drugs of interest but is SARS-CoV-2 positive within 60 days prior to enrollment

      2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA

      Exclusion Criteria:

      1. Participant has a known pregnancy

        For 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)

      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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 20 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chi Hornik (919) 260-7626 chi.hornik@duke.edu
Contact: Jerry Kirchner (919) 812-1798 jerry.kirchner@duke.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04278404
Other Study ID Numbers Pro00103838
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators
  • The Emmes Company, LLC
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Chi Hornik Duke Clinical Research Institute
PRS Account Duke University
Verification Date October 2020