Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury

Phase 2 Completed 46 enrolled AbbVie Janssen Research & Development LLC; Pharmacyclics LLC (An AbbVie Company) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study was to evaluate if ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection.

Timeline

Start: 2020-06-06
Primary completion: 2021-05-10
Completion: 2021-06-08

Outcome

Missed primary endpoint

paper The primary endpoint (proportion of patients alive and without respiratory failure through day 28) was not met PMID 35493119 ↗

registry p =0.599; Adjusted risk difference (%) 5.8 (95% CI -18.1 to 28.7) NCT04375397 ↗

Publications

Coutre SE, Barnett C, Osiyemi O, Hoda D, Ramgopal M, Fort AC, Qaqish R, Hu Y, Ninomoto J, Alami NN, Styles L, Treon SP. Ibrutinib for Hospitalized Adults With Severe Coronavirus Disease 2019 Infection: Results of the Randomized, Double-Blind, Placebo-Controlled iNSPIRE Study. Open Forum Infect Dis. 2022 Mar 24;9(5):ofac104. doi: 10.1093/ofid/ofac104. eCollection 2022 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	420 mg	Oral