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COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
Recruiting
I'm InterestedTrial ID: NCT04588363
Purpose
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)
Eligibility
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.
Intervention(s):
other: SARS-CoV-2 and/or MIS-C Exposure
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Olivia Martinez
650-498-6247