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)
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|ClinicalTrials.gov Identifier: NCT04375397|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : April 15, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|CoronaVirus Induced Disease-2019 (COVID-19)||Drug: Ibrutinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||May 10, 2021|
|Estimated Study Completion Date :||June 11, 2021|
Participants will receive Ibrutinib along with supportive care.
Other Name: Imbruvica
Placebo Comparator: Placebo
Participants will receive Placebo along with supportive care.
- 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.
- 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.
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
|United States, California|
|Stanford Univ School Medicine /ID# 221954|
|Stanford, California, United States, 94305|
|United States, District of Columbia|
|Medstar Washington Hospital Center /ID# 221886|
|Washington, District of Columbia, United States, 20010-3017|
|GW Medical Faculty Associates /ID# 222023|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Midway Immunology and Research /ID# 222004|
|Fort Pierce, Florida, United States, 34982|
|University of Miami /ID# 223227|
|Miami, Florida, United States, 33136|
|Triple O Research Institute /ID# 222944|
|West Palm Beach, Florida, United States, 33407-3100|
|United States, Massachusetts|
|Brigham & Women's Hospital /ID# 221847|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center /ID# 222994|
|Boston, Massachusetts, United States, 02215-5400|
|United States, Utah|
|Intermountain Healthcare /ID# 221955|
|Salt Lake City, Utah, United States, 84103|
|Study Director:||AbbVie Inc.||AbbVie|