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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375397
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC (An AbbVie Company)
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE June 6, 2020
Estimated Primary Completion Date March 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Percentage of Participants Alive and Without Respiratory Failure [ Time Frame: Day 28 ]
Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline [ Time Frame: Day 14 ]
    WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).
  • Median Reduction in Days Spent on Supplemental Oxygen [ Time Frame: Up to Day 28 ]
    Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.
  • All-Cause Mortality [ Time Frame: Up to Day 28 ]
    Percentage of participants with mortality from any cause.
  • Percentage of Participants Experiencing Respiratory Failure or Death [ Time Frame: Up to Day 28 ]
    Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
  • Mechanical Ventilation-Free Survival [ Time Frame: Up to Day 56 ]
    Percentage of participants alive and not requiring mechanical ventilation.
  • Days on Mechanical Ventilation [ Time Frame: Up to Day 56 ]
    Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.
  • Duration of hospitalization [ Time Frame: Up to Day 56 ]
    The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.
  • Time to Discharge [ Time Frame: Up to Day 56 ]
    Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.
  • Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio [ Time Frame: Up to Day 56 ]
    PaO2:FiO2 ratio is an index of respiratory distress.
  • Oxygenation Index [ Time Frame: Up to Day 56 ]
    Oxygenation Index is a parameter of pulmonary function of participants.
  • Number of Participants With Adverse Events [ Time Frame: Up to Day 56 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
  • Number of Participants With Abnormal Laboratory Findings [ Time Frame: Up to Day 56 ]
    Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)
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 is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection.

Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States.

Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care.

There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE CoronaVirus Induced Disease-2019 (COVID-19)
Intervention  ICMJE
  • Drug: Ibrutinib
    Oral Capsule
    Other Name: Imbruvica
  • Drug: Placebo
    Oral Capsule
Study Arms  ICMJE
  • Experimental: Ibrutinib
    Participants will receive Ibrutinib along with supportive care.
    Intervention: Drug: Ibrutinib
  • Placebo Comparator: Placebo
    Participants will receive Placebo along with supportive care.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 25, 2021
Estimated Primary Completion Date March 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 BTK-inhibitor, anti-IL6, anti-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.
  • Participants receiving a strong cytochrome P450 (CYP) 3A4 inhibitor with the exception of those receiving anti-fungal therapy/prophylaxis.
  • Chronic liver disease and hepatic impairment meeting Child Pugh class C.
  • Female participants who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 1 month of last dose of study drug. Male participants who plan to father a child while enrolled in this study or within 3 months after the last dose of study drug.
  • Unwilling or unable to participate in all required study evaluations and procedures.
  • Vaccinated with a live, attenuated vaccine within 4 weeks.
  • Uncontrolled high blood pressure.
  • On therapeutic anticoagulation at baseline.
  • Participants with cancer.
  • Co-enrolled in another interventional trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04375397
Other Study ID Numbers  ICMJE M20-310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (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
URL: http://yoda.yale.edu/
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE
  • Janssen Research & Development, LLC
  • Pharmacyclics LLC (An AbbVie Company)
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP