Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization

Scheinberg P.; Khoshnevis M.R.; Robinson P.A.; Guerreros A.; Sato V.A.H.; Fonseca B.A.L.; Prozesky H.W.; Romero J.O.C.; Fogliatto L.; Meisenberg B.R.; Park D.J.; Gupta A.; Patel P.; Townsley D.M.; Zheng L.; Munugalavadla V. · ImmunoHorizons (2025) · DOI: 10.1093/immhor/vlaf023

Resumen

The efficacy and safety of acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was evaluated in 2 phase 2 studies in hospitalized patients with coronavirus disease 2019 (COVID-19) who received acalabrutinib þ best supportive care (BSC) versus BSC alone (Clinicaltrials.gov: NCT04380688 and NCT04346199). The primary endpoint was the percentage of patients alive and free of respiratory failure on day 14 (rest of the world [RoW] study) and day 28 (US study). In the RoW study, 177 patients were randomized (acalabrutinib þ BSC: n ¼ 89; BSC: n ¼ 88); in the US study, 62 patients were randomized (acalabrutinib þ BSC: n ¼ 31; BSC: n ¼ 31). The percentage of patients who met the primary endpoint was similar in both studies (RoW study: acalabrutinib þ BSC: 83.1%, BSC: 90.9%; US study: acalabrutinib þ BSC: 80.6%, BSC: 83.9%). No new safety concerns were reported. Overall, no significant clinical benefit of adding acalabrutinib to BSC in patients hospitalized with COVID-19 was observed. © The Author(s) 2025.