Analysis Resource Core

JH-EPICS Analysis Resource Core Summary The JH-EPICS Analysis Resource Core (ARC) will provide statistical modeling and analysis support to investigators in this U54 proposal. In addition, the ARC will provide guidance in the framing and testing of hypotheses about the intersectionality of gender, age, racial, and ethnic differences in immune mechanisms in COVID-19. In both roles, the ARC will assure that the U54 research is valid, transparent, and reproducible. Current evidence shows that the COVID-19 pandemic has differential effects on men and women, including in relation to disease severity and mortality and negative social and economic impacts. It is vital that we explore how sex and gender intersect with other biological and social stratifiers if we are to have effective and appropriate therapeutic treatment and interventions. In its statistical analysis role, the ARC will develop and implement statistical models and methods for comparing longitudinal trajectories among subgroups of the Johns Hopkins COVID-19 registry using multiple measures of immune function. We will support the three Research Projects to devise tests of specific hypotheses about baseline and time-varying factors that affect disease progression. In its intersectionality function, the Core will provide expert guidance to both Projects to test hypotheses about the intersectionality of gender (social construct), sex (biological construct), race, ethnicity, and age differences with the effects of SARS-CoV-2 on the human immune system. In collaboration with the U54 investigators, the ARC will: 1. Acquire, manage, and curate data from laboratory experiments and from the Johns Hopkins CROWN (COVID-19 Precision Medicine Analytics Platform) Registry of all COVID-19 patients who receive health services within the Johns Hopkins network of 5 hospitals. 2. Frame the investigators' scientific questions in statistical terms, then design laboratory and/or clinical studies that produce the strongest possible evidence to answer the questions posed. 3. Design and implement statistical analyses and collaborate on interpretation of results so as to produce valid, transparent, and reproducible scientific findings. Validity will be assured by distinguishing hypothesis generating from hypothesis testing analyses. Each hypothesis testing analysis will have a pre-specified statistical analysis plan in advance of working with the data. 4. Analyze the role of sex and gender and the intersection of sex and gender with other biological and social stratifiers, such as age, race, and ethnicity, on COVID-19 immunologic responses and clinical outcomes. These analyses will be integrated into Research Projects 1-3.