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

This phase 2, randomized, double-blind, placebo-controlled, 2-group parallel study recruited HCT recipients 18-75 years of age from 17 centers in 5 countries (Supplemental material, Appendix). Patients presenting any time post-HCT with upper and lower respiratory tract RSV infection documented ≤6 days before start of study treatment and evidence of new abnormalities on chest X-ray obtained ≤48 hours from screening were eligible for inclusion. Lower respiratory tract involvement could be documented from induced sputum, bronchoalveolar lavage, or lung biopsy, but not spontaneous sputum. Patients with documented concurrent LRTI with other respiratory viruses were excluded. Full eligibility criteria are provided in Supplemental methods.