COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C

NCT04588363 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 244

Last updated 2024-02-29

No results posted yet for this study

Summary

The primary objectives of this study are:

* 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.

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • Multisystem Inflammatory Syndrome in Children (MIS-C)
  • Coronavirus Disease 2019 (COVID-19)

Interventions

OTHER

SARS-CoV-2 and/or MIS-C Exposure

This is an observational cohort study.

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER
  • Clinical Trials in Organ Transplantation in Children

    collaborator OTHER
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Steven A. Webber, MBChB, MRCP · Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt

  • James D. Wilkinson, MD, MPH · Vanderbilt Institute for Clinical and Translational Research (VICTR)

  • Natasha B Halasa, MD, MPH · Department of Pediatrics, Vanderbilt University Medical Center

  • Virginia Pascual, MD · Gale and Ira Drukier Institute for Children's Health, Weill Cornell Medicine

  • Betty Diamond, MD · Institute of Molecular Medicine, The Feinstein Institute for Medical Research

  • Ignacio Sanz, MD · Division of Rheumatology, Emory University

  • Olivia Martinez, PhD · Stanford University

  • Sheri Krams, PhD · Stanford University

  • Jeremy Boss, PhD · Emory University

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-03-03
Completion
2023-03-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588363 on ClinicalTrials.gov