COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
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.
Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Multisystem Inflammatory Syndrome in Children (MIS-C)
- Coronavirus Disease 2019 (COVID-19)
Eligibility
- Eligible Ages
- Under 20 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
More Details
- Status
- Completed
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Study Contact
Detailed Description
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).