Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization

NCT04439006 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-20135NCI-2020-03341
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aplastic Anemia; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Monoclonal B-Cell Lymphocytosis; Monoclonal Gammopathy of Undetermined Significance; Myelodysplastic Syndrome; Symptomatic COVID-19 Infection Laboratory-Confirmed

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with diminished respiratory failure and death

  Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.

  During hospitalization for COVID-19 infection or within 30 days of registration

• Death

  During hospitalization for COVID-19 infection or within 30 days of registration

Secondary Outcomes (14)

• Time from study initiation to 48 hours fever-free

  Up to 14 days

• Duration of hospitalization

  Up to 14 days

• Time in intensive care unit (ICU)

  Up to 14 days

• Time to ICU admission

  Up to 14 days

• Number of days requiring supplemental oxygen

  Up to 14 days

Study Arms (2)

Arm A (ibrutinib)

EXPERIMENTAL

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.

Drug: Ibrutinib

Arm B (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm B (usual care)

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Arm A (ibrutinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• New-onset malignancy requiring urgent initiation of systemic chemotherapy
• Active uncontrolled systemic bacterial or fungal or other viral infection
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
• Currently receiving BTK inhibitor therapy
• Actively receiving anti-cancer therapy (other than hormonal therapies). All anti-cancer therapy (except hormonal therapies) must be stopped at the time of screening; can be resumed as soon as ibrutinib is discontinued. Significantly T cell suppressive chemotherapy (defined as requiring PJP prophylaxis per standard guidelines) is not allowed for 3 months prior to enrollment.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional classification requirement for mechanical ventilation at screening
• Known bleeding disorders (e.g., Von Willebrand's disease, platelet storage pool disorders, or hemophilia)
• Stroke or intracranial hemorrhage within 6 months of screening
• Major surgery or non-healing wound within 4 weeks of enrollment
• Concomitant administration of prohibited medications
• Known history of human immunodeficiency virus (HIV), or active hepatitis B or C infection
• Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)
• Requires chronic treatment with strong CYP3A inhibitors

Sponsors & Collaborators

• Jennifer Woyach: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Anemia, Aplastic; Hematologic Neoplasms; Monoclonal Gammopathy of Undetermined Significance; Myelodysplastic Syndromes

Interventions

Practice Guidelines as Topic; Standard of Care; ibrutinib

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Neoplasms by Site; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Jennifer A Woyach, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 23, 2020
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)