Trials / Completed
CompletedNCT04588363
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 244 (actual)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Multisystem Inflammatory Syndrome in Children (MIS-C)
- Coronavirus Disease 2019 (COVID-19)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | SARS-CoV-2 and/or MIS-C Exposure | This is an observational cohort study. |
Timeline
- Start date
- 2020-11-19
- Primary completion
- 2023-03-03
- Completion
- 2023-03-03
- First posted
- 2020-10-19
- Last updated
- 2024-02-29
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04588363. Inclusion in this directory is not an endorsement.