CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04375397
NCT04375397Phase 2Completed
CompareCT.gov

IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)

AbbVie·interventional·Posted May 5, 2020·Updated Jun 1, 2022

In Brief

A Phase 2 clinical trial evaluating Ibrutinib and Placebo for CoronaVirus Induced Disease-2019 (COVID-19). Completed, enrolled 46 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronaVirus Induced Disease-2019 (COVID-19)
CountriesUnited States
CollaboratorsJanssen Research & Development LLC; Pharmacyclics LLC (An AbbVie Company)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 5, 2020
Enrollment StartJun 6, 2020
Primary CompletionMay 10, 2021
Study CompletionJun 8, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.2 years ago

Interventions

Ibrutinibdrug

Capsules were to be administered orally with water once daily. For participants who required nasogastric tube (NGT) placement while on study, capsules may have been administered by opening the capsules, mixing with water, and flushing down the NGT.

Placebodrug

Capsules were to be administered orally with water once daily. For participants who required nasogastric tube (NGT) placement while on study, capsules may have been administered by opening the capsules, mixing with water, and flushing down the NGT.