COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
Trial ID or NCT#
Status
RECRUITING
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)
Eligibility 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.
- 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Olivia Martinez
650-498-6247
View on ClinicalTrials.gov
