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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jennifer Woyach
Study ID
NCT04439006
Phase
PHASE1
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive usual care
  • Ibrutinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Oct 23, 2020
Status verified
Dec 2023
Primary completion
Sep 20, 2022
Completion
Sep 20, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Proportion of patients with diminished respiratory failure and death [ Time Frame: During hospitalization for COVID-19 infection or within 30 days of registration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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