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.

To our knowledge, this is the first randomized controlled trial to demonstrate potential efficacy using immune plasma in the treatment of a respiratory virus disease. Although the study was not able to conclusively demonstrate efficacy based upon the primary endpoint (resolution of tachypnea/hypoxia); the fact that 14% more patients in the treatment arm had resolution of tachypnea/hypoxia (p=0·069) coupled with the significant improvement seen in clinical status at Day 7 (p=0·020), decreased mortality (1 vs. 5, p=0·093), and multiple other secondary endpoints all suggest benefit to treatment with immune plasma. Furthermore, it appears that maximum benefit accrues to the use of plasma < 4 days of symptom onset though a definitive conclusion will require further study (see Figure 2B ). Based on this data, a larger, randomized, double blind, placebo controlled trial is currently underway (ClinicalTrials.gov Identifier: NCT02572817).