COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
NCT ID: NCT04588363
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
244 participants
OBSERVATIONAL
2020-11-19
2023-03-03
Brief Summary
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* To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and
* To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
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Detailed Description
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Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals \<21 years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the United States. The study period of participation is 1 year (12 months).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SARS-CoV-2 positive children
Individuals less than 21 years of age who fulfill one or more of the following criteria:
* SARS-CoV-2 detection from a respiratory specimen, and/or
* Meets criteria for MIS-C, and/or
* Meets criteria for MIS-C, except has involvement of only 1 organ system
SARS-CoV-2 and/or MIS-C Exposure
This is an observational cohort study.
Interventions
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SARS-CoV-2 and/or MIS-C Exposure
This is an observational cohort study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
3. Meets criteria for MIS-C, except has involvement of only 1 organ system
Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed MIS-C.
Exclusion Criteria
--Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
20 Years
ALL
No
Sponsors
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Autoimmunity Centers of Excellence
OTHER
Clinical Trials in Organ Transplantation in Children
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Steven A. Webber, MBChB, MRCP
Role: STUDY_CHAIR
Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt
James D. Wilkinson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Institute for Clinical and Translational Research (VICTR)
Natasha B Halasa, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Vanderbilt University Medical Center
Virginia Pascual, MD
Role: PRINCIPAL_INVESTIGATOR
Gale and Ira Drukier Institute for Children's Health, Weill Cornell Medicine
Betty Diamond, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Molecular Medicine, The Feinstein Institute for Medical Research
Ignacio Sanz, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Rheumatology, Emory University
Olivia Martinez, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Sheri Krams, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Jeremy Boss, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Loma Linda University Health
Loma Linda, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
NewYork-Presbyterian Queens Hospital
Flushing, New York, United States
Cohen Children's Medical Center - Northwell Health
New Hyde Park, New York, United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York, United States
NewYork-Presbyterian Komansky Children's Hospital
New York, New York, United States
Mount Sinai Kravis Children's Hospital
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Duke University Children's Health Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Countries
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Related Links
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Clinical Trials in Organ Transplantation in Children
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infection Diseases
Other Identifiers
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NIAID CRMS ID#: 38772
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT PRISM-01
Identifier Type: -
Identifier Source: org_study_id
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