COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus Disease 2019 (COVID-19); Multisystem Inflammatory Syndrome in Children (MIS-C)

Treatments: Other: SARS-CoV-2 and/or MIS-C Exposure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04588363

NIAID CRMS ID#: 38772 (Other Identifier)

DAIT PRISM-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 244 patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

244 participants in 1 patient group

SARS-CoV-2 positive children

Description:

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

Treatment:

Other: SARS-CoV-2 and/or MIS-C Exposure