The University of Nebraska Medical Center and Nebraska Medicine established its variation of the Clinical Characterization Protocol for Severe Emerging Infections (CCPSEI) during the COVID-19 pandemic. CCPSEI is a prospective, observational cohort study that enrolls suspected and confirmed cases of high consequence pathogens, such as pandemic-threat disease, those listed on the U.S. Select Agent list, and other emerging and re-emerging threats that are particularly problematic for patients and communities.The protocol was adapted from the harmonized clinical trial efforts of the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC).
CCPSEI is approved by the UNMC | NM Institutional Review Board, protocol number 146-20-FB, and has been adopted by other centers both through the central IRB mechanism for the Special Pathogen Research Network as well as independently. A brief description of the study and its initiation is available on-line.(https://doi.org/10.4269/ajtmh.20-0205)