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
iNSPIRE
IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)
1 other identifier
interventional
46
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2020
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedStudy Start
First participant enrolled
June 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2021
CompletedResults Posted
Study results publicly available
June 1, 2022
CompletedJune 1, 2022
May 1, 2022
11 months
May 4, 2020
April 22, 2022
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Alive and Without Respiratory Failure Through Day 28
Respiratory failure is defined as a clinical diagnosis of respiratory failure and initiation of one of the following therapies: endotracheal intubation and mechanical ventilation; OR extracorporeal membrane oxygenation; OR high-flow nasal cannula oxygen delivery (i.e., reinforced nasal cannula delivering heated, humidified oxygen with fraction of delivered oxygen ≥ 0.5 and flow rates of ≥ 30 L/min); OR non-invasive positive pressure ventilation; OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation.
Through Day 28
Secondary Outcomes (11)
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14
At Day 14
Median Reduction in Days Spent on Supplemental Oxygen
Up to Day 28
All-Cause Mortality at Study Days 7, 14, 21, and 28
At Study Days 7, 14, 21, and 28
Percentage of Participants Experiencing Respiratory Failure or Death on Study Days 7, 14, 21, and 28
At Study Days 7, 14, 21, and 28
Mechanical Ventilation-Free Survival
Up to Day 28
- +6 more secondary outcomes
Study Arms (2)
Ibrutinib 420 mg + SOC
EXPERIMENTAL420 mg ibrutinib administered once daily as three hard gelatin capsules (140 mg each) with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
Placebo + SOC
PLACEBO COMPARATORThree hard gelatin placebo capsules administered once daily with approximately 240 mL of water for up to 28 days and supportive care (standard-of-care, SOC)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Requires hospitalization for COVID-19 infection
- Has Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by reverse transcription polymerase chain reaction (RT-PCR) test before study entry
- Requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 5 days, and on breathing room air have oxygen saturation levels of 94% or less
- Has radiographic evidence of pulmonary infiltrates
- Females of childbearing potential (FCBP) must use 1 reliable form of contraception or have complete abstinence from heterosexual intercourse during the following time periods related to this study: while participating in the study; and for at least 1 month after discontinuation of study drug. FCBP must be referred to a qualified provider of contraceptive methods if needed. FCBP must have a negative serum pregnancy test as of screening.
- Men must agree to use a latex condom during treatment and for up to 3 months after the last dose of ibrutinib during sexual contact with a FCBP.
- Adequate hematologic, hepatic and renal function as described in the protocol
- Must be within 10 days of confirmed diagnosis of COVID-19
You may not qualify if:
- Respiratory failure at time of screening as defined per protocol with any of these following therapies:
- Endotracheal intubation and mechanical ventilation
- Extracorporeal membrane oxygenation (ECMO)
- High flow nasal cannula oxygen at flow rates ≥ 30 L/min and fraction of delivered oxygen ≥ 0.5
- Non-invasive positive pressure ventilation
- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- On a Bruton's tyrosine kinase (BTK)-inhibitor, anti-interleukin 6 (IL6), anti-interleukin 6R (IL6R), or Janus kinase inhibitor (JAKi)
- Has received rituximab within 180 days from study entry.
- Known bleeding disorders
- Major surgery within 4 weeks of study entry
- Participants in whom surgery is anticipated to be necessary within 72 hours
- History of stroke or bleeding around or within brain within 6 months prior to enrollment
- Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV)
- Currently active, clinically significant cardiovascular disease
- Asymptomatic arrythmias and or history of ejection fraction \< 40% on an echo
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Stanford University School of Med /ID# 221954
Stanford, California, 94305-2200, United States
Medstar Washington Hospital Center /ID# 221886
Washington D.C., District of Columbia, 20010-3017, United States
Duplicate_GW Medical Faculty Associates /ID# 222023
Washington D.C., District of Columbia, 20037, United States
Midway Immunology and Research /ID# 222004
Ft. Pierce, Florida, 34982, United States
University of Miami /ID# 223227
Miami, Florida, 33136, United States
Triple O Research Institute /ID# 222944
West Palm Beach, Florida, 33407-3100, United States
Brigham & Women's Hospital /ID# 221847
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center /ID# 222994
Boston, Massachusetts, 02215-5400, United States
Intermountain Healthcare /ID# 221955
Salt Lake City, Utah, 84103, United States
Related Publications (1)
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.
PMID: 35493119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 5, 2020
Study Start
June 6, 2020
Primary Completion
May 10, 2021
Study Completion
June 8, 2021
Last Updated
June 1, 2022
Results First Posted
June 1, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Requests for access to individual participant data from ibrutinib clinical studies conducted by AbbVie can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.