NCT04278404 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
| NCT ID | NCT04278404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Coronavirus Infection (COVID-19) |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2020-03-05 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2020-03-05 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Chi Hornik
PRINCIPAL INVESTIGATOR
Duke Clinical Research Institute
Frequently Asked Questions
Who can join the NCT04278404 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 20 Years, studying Coronavirus Infection (COVID-19). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04278404 currently recruiting?
Yes, NCT04278404 is actively recruiting participants. Contact the research team at chi.hornik@duke.edu for enrollment information.
Where is the NCT04278404 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT04278404 clinical trial?
NCT04278404 is sponsored by Duke University. The principal investigator is Chi Hornik at Duke Clinical Research Institute. The trial plans to enroll 5,000 participants.
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