Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe … (NCT04375397) | Clinical Trial Compass
CompletedPhase 2
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
United States46 participantsStarted 2020-06-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ox…
What they're measuring
1
Percentage of Participants Alive and Without Respiratory Failure Through Day 28