COVID-19 real world data infrastructure: A big data resource for study of the impact of COVID-19 in patient populations with immunocompromising conditions

BackgroundWe created a United States-based real-world data resource to better understand the continued impact of the COVID-19 pandemic on immunocompromised patients, who are typically under-represented in prospective studies and clinical trials. Methods: The COVID-19 Real World Data infrastructure (CRWDi) was created by linking and harmonizing deidentified HealthVerity medical and pharmacy claims data from December 1, 2018 to December 31, 2023, with SARS-CoV-2 virologic and serologic laboratory data from major commercial laboratories and Northwell Health; COVID-19 vaccination data; and for patients with cancer, 2010 to 2021 National Cancer Institute Surveillance, Epidemiology, and End Results registry data. Results: The CRWDi dataset contains data on 5.2 million people. Four populations were included in the dataset: (1) patients with cancer (n=1,294,022); (2) patients with rheumatic conditions receiving pharmacotherapy (n=1,636,940); (3) non-cancer solid organ (n=249,797) and hematopoietic stem cell (n=30,172) transplant recipients; and (4) people from the general population including adults (>18 years of age; n=1,790,162) and pediatric patients (<18 years of age; n=198,907). ConclusionsWe have created a complex real-world data system to address unanswered questions that have arisen during the COVID-19 pandemic. Further, by making the data broadly and freely available to academic researchers from the United States, the CRWDi real-world data system represents an important complement to existing consortia studies and clinical trials that have emerged during the healthcare crisis, and is readily reproducible for future purposing. SummaryThe COVID-19 Real World Data infrastructure dataset contains 5.2 million deidentified patient records, with focus on immunocompromising conditions, and is freely available to approved researchers to study the impact of coronavirus disease 2019 (COVID-19) on patient morbidities and outcomes.