A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

Marty, Francisco M; Chemaly, Roy F; Mullane, Kathleen M; Lee, Dong-Gun; Hirsch, Hans H; Small, Catherine B; Bergeron, Anne; Shoham, Shmuel; Ljungman, Per; Waghmare, Alpana; Blanchard, Elodie; Kim, Yae-Jean; McKevitt, Matt; Porter, Danielle P; Jordan, Robert; Guo, Ying; German, Polina; Boeckh, Michael; Watkins, Timothy R; Chien, Jason W; Dadwal, Sanjeet S

Patients were randomly assigned (1:1) to receive presatovir or placebo, stratified centrally by supplemental oxygen use (none to ≤2 L/min vs >2 L/min) and ribavirin use (prescribed at randomization, any route of administration) during the current RSV infection. The randomization schedule used permuted blocks of 2. Allocation was concealed by use of presatovir and placebo tablets with identical appearance. Study treatment assignment information was provided by an interactive web response system (Bracket Global, Wayne, PA, USA). Patients, all study staff, and sponsor were masked to study treatment.