Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04278404 | RECRUITING | Coronavirus Infection (COVID-19)

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

Duke University

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.

Condition or disease

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/treatment

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:

Study Type : OBSERVATIONAL
Estimated Enrollment : 5000 participants
Official Title : Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Actual Study Start Date : 2020-03-05
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Location Details

NCT04278404

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, Arizona

Phoenix Children's Hospital

Phoenix, arizona, United States, 85016

RECRUITING

United States, Arkansas

Arkansas Children's Hospital Research Institute

Little Rock, arkansas, United States, 72202

RECRUITING

United States, California

University of California, Los Angeles Medical Center

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Lucile Packard Children's Hospital

Palo Alto, California, United States, 94304

RECRUITING

United States, Colorado

Colorado University Denver

Aurora, Colorado, United States, 80045

RECRUITING

United States, Colorado

The Children's Hospital Colorado

Aurora, Colorado, United States, 80045

COMPLETED

United States, Delaware

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States, 19803

RECRUITING

United States, Florida

University of Florida Jacksonville Shands Medical Center

Jacksonville, florida, United States, 32209

RECRUITING

United States, Hawaii

Kapiolani Womens and Childrens Medical Center

Honolulu, Hawaii, United States, 96826

RECRUITING

United States, Illinois

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States, 60614

RECRUITING

United States, Indiana

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Iowa

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

COMPLETED

United States, Kansas

University of Kansas Medical Center-JG Kidney Institute

Kansas City, Kansas, United States, 66160

RECRUITING

United States, Kentucky

University of Louisville Norton Childrens Hospital

Louisville, Kentucky, United States, 40202

COMPLETED

United States, Louisiana

Tulane University Health Science Center

New Orleans, Louisiana, United States, 70112

RECRUITING

United States, Louisiana

Ochsner Baptist Clinical Trials Unit

New Orleans, Louisiana, United States, 70115

COMPLETED

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

ENROLLING BY INVITATION

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Lexington, Massachusetts, United States, 02421

COMPLETED

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

COMPLETED

United States, Mississippi

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States, 39110

COMPLETED

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

RECRUITING

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68114

COMPLETED

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

COMPLETED

United States, New Mexico

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States, 87131

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Ohio

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Oklahola

Board of Regents of the University of Oklahoma

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Pennsylvania State University--Hershey Children's Hospital

Hershey, Pennsylvania, United States, 17033

COMPLETED

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

RECRUITING

United States, South Carolina

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, United States, 29425

COMPLETED

United States, South Carolina

University of South Carolina

Columbia, South Carolina, United States, 29208

COMPLETED

United States, South Dakota

Avera McKennan Hospital & University Medical Center

Sioux Falls, South Dakota, United States, 57108

RECRUITING

United States, Tennessee

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Texas

Dell Children's Medical Center of Central Texas

Austin, Texas, United States, 78723

ACTIVE NOT RECRUITING

United States, Texas

University of Texas-Southwestern Medical Center Dallas

dallas, Texas, United States, 75390

RECRUITING

United States, Texas

University of Texas--Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

The Womens Hospital of Texas

Houston, Texas, United States, 77054

RECRUITING

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84113

RECRUITING

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

ACTIVE NOT RECRUITING

United States, West Virginia

West Virginia University Hospital

Morgantown, West Virginia, United States, 26506

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705

ENROLLING BY INVITATION

United States, Wisconsin

University Wisconsin Madison

Madison, Wisconsin, United States, 53705

RECRUITING

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

RECRUITING

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada,

RECRUITING

Canada, Quebec

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5