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.
This is a prospective, multicenter, observational cohort study to assess short and long-term
clinical outcomes and immune responses after Severe Acute Respiratory Syndrome Coronavirus 2
(SARS-CoV-2) infection and/or Multisystem Inflammatory Syndrome in Children (MIS-C) in
children (e.g., defined as individuals who have not reached their 21st birthday at the time
of enrollment). SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19)
Participants will be identified through active recruitment measures within hospitals and
through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals <21
years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic
background, from participating medical centers in the United States. The study period of
participation is 1 year (12 months).
Other: SARS-CoV-2 and/or MIS-C Exposure
This is an observational cohort study.
Other Name: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis
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.
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
Saint Louis, Missouri, United States
Children's Hospital at Montefiore
Bronx, New York, 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
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