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 unblinded design was another limitation of the study. Potential placebos (e.g. saline with albumin) were debated during protocol development, although even with elaborate blinding schemes the study team is unlikely to have been effectively blinded. Ultimately it was concluded that incorporation of a placebo should await a larger, more definitive trial. One unintended consequence of this decision was the observation that losses to follow up appeared to be somewhat higher in the participants that received standard care as compared to those that received plasma. After being consented but then informed that no specific study treatment would be provided, we suspect that participants that received standard care were less motivated to complete all study visits. This however, did not compromise our ability to ascertain the primary endpoint.