Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization (NCT04439006) | Clinical Trial Compass
CompletedPhase 1
Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization
United States10 participantsStarted 2020-10-23
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History or active diagnosis of cancer (solid or hematologic) or precursor of cancer (monoclonal gammopathy of undetermined significance \[MGUS\]), monoclonal B lymphocytosis (MBL), aplastic anemia or myelodysplastic syndrome) that is associated with immune suppression
* Hospitalization for confirmed polymerase chain reaction (PCR) positive COVID-19 infection
* Patients with evidence of pulmonary involvement who meet any of the followings; presence of infiltrates on chest X-ray or computed tomography (CT) scan or need for supplemental oxygen \< 8 L nasal cannula or pulse oximetry \< 94% on room air
* Creatinine clearance \>= 25 ml/min by Cockcroft-Gault equation
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
* Absolute neutrophil count (ANC) \>= 1000/mm\^3 independent of growth factor support
* Platelets \>= 50,000/mm\^3
* Ability to swallow capsules
* Ability to provide informed consent indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
* Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participatingā¦
What they're measuring
1
Proportion of patients with diminished respiratory failure and death
Timeframe: During hospitalization for COVID-19 infection or within 30 days of registration
2
Death
Timeframe: During hospitalization for COVID-19 infection or within 30 days of registration