PRISM is a prospective cohort study of children, adolescents, and young adults recruited at 23 children’s hospitals and academic medical centers from across the U.S. In the initial phase, we will enroll 250 young people infected with SARS-CoV-2 from both inpatient and outpatient settings and follow them for one year.
At regular research visits, PRISM participants will undergo detailed clinical assessments, provide periodic blood, saliva, nasal, urine, and stool specimens, receive research electrocardiograms, echocardiograms, chest CTs, pulmonary function testing, and HRQOL assessments.
The primary study clinical outcomes are rates of hospital and intensive care admissions, mortality, rehospitalizations and major complications including end-organ damage or dysfunction. We will also study difference in clinical features between those hospitalized with MIS-C and non-hospitalized participants.
The primary mechanistic outcome is to determine immunologic mechanisms and immune signatures associated with different phenotypes of disease presentation. The PRISM core mechanistic laboratories will perform testing on participants' biospecimens including viral shedding and antibody responses, immune phenotyping, various T and B cell studies, transcriptomic, proteomic, and metabolomic studies, host and virus genotyping, among others. PRISM will also create a biobank of participants’ biospecimens for future studies.
Longer term goals include increasing the cohort size and follow-up time and to perform additional clinical, immunological, virological and mechanistic testing based on the initial study findings.