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


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Trial ID: NCT04588363


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.

Official Title

An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C)

Stanford Investigator(s)


Inclusion Criteria:

   1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a
   respiratory specimen, and/or

   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:

1. 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.


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


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Olivia Martinez