No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 – 20
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for children and young adults up to 21 years old to learn how certain medications work in their bodies. Participants will either be taking one of the medications of interest or have tested positive for COVID-19 in the last 60 days.
Are You a Good Fit for This Trial?
You may be able to join if
I am under 21 years old.
I can understand the consent process and will give my permission.
I am receiving one or more of the study drugs.
I tested positive for COVID-19 in the last 60 days.
You may not be able to join if
I am pregnant.
I have had intermittent dialysis in the past 24 hours.
I have had a kidney transplant in the past 30 days.
I have had a liver transplant in the past year.
I have had a stem cell transplant in the past year.
I have had therapeutic hypothermia in the past 24 hours.
I have had plasmapheresis in the past 24 hours.
I have a Ventricular Assist Device.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 treati…
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.
Trial Locations
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City
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Status
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) Part…
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
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