A Randomized Study of Immune Plasma for the Treatment of Severe Influenza

Beigel, John H.; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E.; Cairns, Charles B.; Shoham, Shmuel; Deville, Jaime G.; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O’Neil, Dorothy; Metcalf, Julia A.; King, Karen; Burgess, Timothy H.; Aga, Evgenia; Lane, H. Clifford; Hughes, Michael D.; Davey, Richard T.

The study used units of human plasma that met all requirements for FDA licensed Fresh Frozen Plasma (FFP) and were pre-screened for hemagglutination inhibition (HAI) titer(s) by a central laboratory. All units were required to have a HAI titer of at least 1:40, though the units used for participants with influenza A had a geometric mean HAI titer for H1N1 or H3N2 of 1:259 or 1:158 respectively (range 1:80-1:1280), and for influenza B a geometric mean HAI titer of 1:101 (1:80-1:640). At the beginning of the study, plasma was collected by donor directed programs (screening participants for high titer HAI, and then serially collecting plasma from these individuals). Through the course of the study, the plasma collection was changed to screening units of plasma from blood establishments to identify units with high HAI titers to influenza A or influenza B. This allowed larger volumes of plasma to be collected to support the treatment study.