Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

Summary

The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.

Timeline

Start

2020-07-06

Primary completion

2021-02-01

Completion

2021-02-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Zanubrutinib + Supportive Care vs Placebo + Supportive Care; p = 0.4099; Odds Ratio (OR) 1.61 (95% CI 0.349 to 7.391); NCT04382586 ↗

registry analysis (superiority test); Zanubrutinib + Supportive Care vs Placebo + Supportive Care; p = 0.7619; Hazard Ratio (HR) 0.918 (95% CI 0.511 to 1.648); NCT04382586 ↗

paper In cohort 1, respiratory failure-free survival and the estimated rates of not returning to breathing room air by day 28 were not significantly different between treatments. PMID 39906744 ↗

paper Despite these immunological findings, zanubrutinib did not show improvement over placebo in clinical recovery from respiratory distress. PMID 39906744 ↗

release “BRUKINSA® (zanubrutinib) in patients hospitalized with respiratory symptoms of COVID-19, requiring supplemental oxygen without mechanical ventilation, did not meet the co-primary efficacy endpoints” beonemedicines.com ↗

Publications

• Treon SP, Kotton CN, Park DJ, Moranzoni G, Lemvigh CK, Gathe JC Jr, Varughese TA, Barnett CF, Belenchia JM, Clark NM, Farber CM, Abid MB, Ahmed G, Patterson CJ, Guerrera ML, Soumerai JD, Chea VA, Carulli IP, Southard J, Li S, Wu CJ, Livak KJ, Holmgren E, Kim P, Shi C, Lin H, Ramakrishnan V, Ou Y, Olszewski S, Olsen LR, Keskin DB, Hunter ZR, Tankersley C, Zimmerman T, Dhakal B. A randomized, placebo-controlled trial of the BTK inhibitor zanubrutinib in hospitalized patients with COVID-19 respiratory distress: immune biomarker and clinical findings. Front Immunol. 2025 Jan 21;15:1369619. doi: 10.3389/fimmu.2024.1369619. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zanubrutinib	Small molecule	320 mg	Oral

Indications