Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19

Novel therapies for SARS-CoV-2 infection have been a focus of research and enquiry, and many promising compounds tested in phase 1 and 2 trials have emerged. In this multinational clinical trial, one such compound—a designed ankyrin repeat protein, ensovibep—was compared with standard of care to determine whether it improved outcomes among patients hospitalized with COVID-19. After randomly assigning 485 patients, the trial was stopped for early futility because the odds of a more favorable pulmonary outcome were no different in those randomized to treatment versus control. This study highlights that effective antiviral therapies for patients hospitalized with COVID-19 remain an unmet need. Even though this trial was negative, important lessons regarding how to conduct such trials and test promising compounds can be gleaned from this study.

Karla P. Zepeda | Christina C. Chang | Kamil H A Kim | W. Self | N. Gerry | A. Ginde | H. Günthard | R. Paredes | R. Dewar | S. Vogel | V. Natarajan | A. Phillips | J. Lundgren | K. Syrigos | A. Weintrob | J. Neaton | A. Kelleher | B. Grund | C. Reilly | D. Murray | D. Lye | D. Vock | N. Koulouris | E. Mylonakis | Z. Barmparessou | I. Kalomenidis | G. Grandits | D. Braun | S. Bhagani | A. Rodger | G. Touloumi | A. Gelijns | B. Trautner | I. Kimuli | B. Young | A. Bednarska | F. Hudson | K. Knowlton | E. Higgs | A. Babiker | S. Pett | C. Barkauskas | M. Teitelbaum | D. Vallée | N. Engen | L. Leither | P. Legenne | P. Robinson | Adriana Sánchez | U. Sandkovsky | G. Poulakou | K. Protopapas | C. Chang | Mamta K. Jain | M. Padilla | Sylvain Laverdure | V. Menon | M. T. Rehman | H. Highbarger | Page E. Crew | E. Almasri | A. Osuji | Srikanth Ramachandruni | Samuel M Brown | R. Chandra | Peter Chen | K. Shaw-Saliba | Francis Kiweewa | A. Vekstein | S. Vasudeva | R. Gottlieb | V. Rapti | Ralph Rogers | B. Thompson | T. Jensen | C. North | E. Mylona | F. Shehadeh | J. Overcash | M. Waters | V. Davey | Adam Schechner | T. Hatlen | V. Kan | H. Lane | G. Matthews | S. Nagy-Agren | M. Matthay | Shweta Sharma | Amiran Baduashvili | A. Hughes | Evan X. Accardi | N. Mosaly | S. H. Diong | J. Badrock | Joseph K. Lutaakome | L. Siegel | Matthew Kaczynski | Rubria Marines‐Price | S. Torbati | Nicholus Sebudde | Eriobu Nnakelu | Robert Kidega | Negin Atri | D. Looney | H. H. Nguyen | Lindsay M. Leither | Samuel M. Brown | M. Jain | J. Lutaakome | S. Laverdure | Daniel D. Murray | Michael Matthay | Page E Crew | Evan Accardi | Helene Highbarger

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