Nationwide Expanded Access Program (EAP) to facilitate the use of human convalescent plasma to treat hospitalized coronavirus-2 (SARS-CoV-2) COVID-19 patients

The overall goal of the proposed work is to support a nationwide Expanded Access Program (EAP) to facilitate the use of human convalescent plasma to treat hospitalized coronavirus-2 (SARS-CoV-2) COVID-19 patients. The overarching goal of this project is develop a set of tools that physicians at the bedside can use to administer COVID-19 convalescent plasma to hospitalized COVID-19 patients to increase the survival rate. These tools will be largely web based and include: (1) Comprehensive background information including key administrative and clinical workflows; (2) Robust user support staffed by high-level, content experts via direct calls with physician and nurse navigators, a call center, and dedicated email address; (3) Simple and compliant enrollment documentation for institutions, physicians, and patients; (4) Centralized regulatory and ethical support via central IRB and DSMB; (5) Information and forms about how to consent patients in a safe and compliant manner; (6) Case report forms for timely data reporting; (7) Infrastructure for comprehensive, program-wide data analysis and broad-based reporting of results; (8) Biobank apabilities for retrospective analysis of convalescent plasma samples to determine how factors like antibody titers related to changes in patient outcomes; and (9) Modest financial support for each patient enrolled.