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SECURE-AIC Registry: Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion for Autoimmune Cytopenias
The SECURE-AIC Registry is designed to capture information about SARS-CoV2 vaccine tolerance and SARS-CoV2 infections in pediatric and young adult patients (ages 0 to 21 years) living with autoimmune cytopenias (AIC) or with a recent history of autoimmune cytopenias (within the last three years). The goal of SECURE-AIC Registry is to report on outcomes of cases of COVID-19, multisystem inflammatory syndrome in children (MIS-C), and vaccine-associated changes in blood counts.
Providers caring for these patients can report all cases of SARS-CoV2 vaccination and/or COVID-19 or MIS-C to this registry, in addition to all applicable federal monitoring sites. Reporting of a case should take about 5 to 10 minutes.
With our community of providers worldwide, working together, we will be able to quickly determine the specific impact of the newly approved pediatric vaccines on patients with autoimmune cytopenias and be able to better counsel patients on safety regarding their specific concerns ("How will this affect my ITP/AIHA?"), as well as the effect of modifying therapies on responses.
Providers who actively contribute to this voluntary reporting system will help to ensure an unbiased data set.
Study Highlights
- The SECURE-AIC Registry is an international effort - we are hoping for robust participation and collaboration.
- We will provide the autoimmune cytopenia community with regularly updated summary information.
- The SECURE-AIC Registry contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards.
- Children's Hospital of Philadelphia's Institutional Review Board has determined that collection, storage, and analysis of de-identified data meets the exemption criteria per 45 CFR 46.104(d) 4(ii).