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

Completed

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

In brief

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.

Key facts

Study ID

NCT04588363

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

244

Starts

2020-11-19

Expected to finish

2023-03-03

Last updated by the study team

2024-02-29

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
• Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
• 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.

You may not qualify if…

• Subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent
• -Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.

Where it is running

• 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

Full record on ClinicalTrials.gov

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