Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In

Who is this study for? Adult patients with Solid Tumors or Hematological Malignancy
What treatments are being studied? Ibrutinib
Status: Completed
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug

• Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
Columbus
Time Frame
Start Date: 2020-10-23
Completion Date: 2022-09-20
Participants
Target number of participants: 10
Treatments
Experimental: Arm A (ibrutinib)
Patients receive ibrutinib PO QD on days 1-7. Treatment repeats every 7 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who remain hospitalized or are re-admitted after 2 cycles may receive an additional 2 cycles per physician's discretion.
Active_comparator: Arm B (usual care)
Patients receive usual care.
Sponsors
Leads: Jennifer Woyach
Collaborators: Janssen Scientific Affairs, LLC

This content was sourced from clinicaltrials.gov

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