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)

Status: Completed
Location: See all (20) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Loma Linda University Health
Loma Linda
Cedars-Sinai Medical Center
Los Angeles
Children's Hospital Los Angeles
Los Angeles
Lucile Packard Children's Hospital Stanford
Palo Alto
Georgia
Children's Healthcare of Atlanta
Atlanta
Minnesota
Mayo Clinic Rochester
Rochester
Missouri
St. Louis Children's Hospital
St Louis
North Carolina
Duke University Children's Health Center
Durham
New York
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn
NewYork-Presbyterian Queens Hospital
Flushing
Cohen Children's Medical Center - Northwell Health
New Hyde Park
Hassenfeld Children's Hospital at NYU Langone
New York
Mount Sinai Kravis Children's Hospital
New York
NewYork-Presbyterian Komansky Children's Hospital
New York
Children's Hospital at Montefiore
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
UPMC Children's Hospital of Pittsburgh
Pittsburgh
South Carolina
Medical University of South Carolina, Pediatric Rheumatology
Charleston
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville
Time Frame
Start Date: 2020-11-19
Completion Date: 2023-03-03
Participants
Target number of participants: 244
Treatments
SARS-CoV-2 positive children
Individuals less than 21 years of age who fulfill one or more of the following criteria:~* SARS-CoV-2 detection from a respiratory specimen, and/or~* Meets criteria for MIS-C, and/or~* Meets criteria for MIS-C, except has involvement of only 1 organ system
Sponsors
Collaborators: Clinical Trials in Organ Transplantation in Children, Autoimmunity Centers of Excellence
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov