Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : June 25, 2020
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC (An AbbVie Company)
Information provided by (Responsible Party):
AbbVie

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 will 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.


Condition or disease Intervention/treatment Phase
CoronaVirus Induced Disease-2019 (COVID-19) Drug: Ibrutinib Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)
Actual Study Start Date : June 6, 2020
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : September 10, 2020


Arm Intervention/treatment
Experimental: Ibrutinib
Participants will receive Ibrutinib along with supportive care.
Drug: Ibrutinib
Oral Capsule
Other Name: Imbruvica

Placebo Comparator: Placebo
Participants will receive Placebo along with supportive care.
Drug: Placebo
Oral Capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. All-Cause Mortality [ Time Frame: Up to Day 28 ]
    Percentage of participants with mortality from any cause.

  4. 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.

  5. Mechanical Ventilation-Free Survival [ Time Frame: Up to Day 56 ]
    Percentage of participants alive and not requiring mechanical ventilation.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Oxygenation Index [ Time Frame: Up to Day 56 ]
    Oxygenation Index is a parameter of pulmonary function of participants.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requires hospitalization for COVID-19 infection.
  • Has Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (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 48 hours, and on no more than 6 Litres/minute, and on breathing room air have oxygen saturation levels of 94% or less.
  • Adequate hematologic, hepatic and renal function as described in the protocol.
  • Must be within 10 days of confirmed diagnosis of COVID-19.

Exclusion Criteria:

  • Participant is on mechanical ventilation.
  • Unable to take study medication.
  • 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.
  • 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.
  • Participants with cancer.
  • Co-enrolled in another interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375397


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Layout table for location information
United States, California
Stanford Univ School Medicine /ID# 221954 Not yet recruiting
Stanford, California, United States, 94305
United States, District of Columbia
Medstar Washington Hospital Center /ID# 221886 Recruiting
Washington, District of Columbia, United States, 20010-3017
GW Medical Faculty Associates /ID# 222023 Not yet recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Midway Immunology and Research /ID# 222004 Recruiting
Fort Pierce, Florida, United States, 34982
United States, Massachusetts
Brigham & Women's Hospital /ID# 221847 Recruiting
Boston, Massachusetts, United States, 02115
United States, Utah
Intermountain Healthcare /ID# 221955 Recruiting
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
AbbVie
Janssen Research & Development, LLC
Pharmacyclics LLC (An AbbVie Company)
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04375397    
Other Study ID Numbers: M20-310
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

Layout table for additional information
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
Keywords provided by AbbVie:
CoronaVirus Induced Disease-2019
COVID-19
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Pulmonary Injury
Ibrutinib
Imbruvica
Respiratory failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency
Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Lung Diseases
Thoracic Injuries
Wounds and Injuries