Trial of Imatinib for Hospitalized Adults With COVID-19

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria

Patients may be included in the study only if they meet all of the following criteria:

1. Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or ECMO, Legally Authorized Representative (LAR) can sign the informed consent.

2. Hospitalized patients ≥ 18 years of age

3. Positive RT-PCR assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or BAL) by Center for Disease Control or local laboratory within 7 days of randomization.

Exclusion Criteria

Patients meeting any of the following criteria are not eligible for the study:

1. Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion. Therapies that are shown to be effective but may not be licensed can be added as an exception to the exclusion criteria in order to allow for the most contemporary standard of care to include emergency use authorization treatments as they become available. Antivirals such as remdesivir will be permissible given the FDA authorized emergency use.

2. Pregnant or breastfeeding women.

3. Patients with significant liver or renal dysfunction function at screen as defined as:

• Direct bilirubin > 2.5 mg/dL

• AST, ALT, or alkaline phosphatase > 5 x upper limit of normal

• eGFR ≤ 30 mL/min or requiring renal replacement therapy

4. Patients with significant hematologic disorder at screen as defined as:

• Absolute neutrophil count (ANC) < 500/μL

• Platelet < 20,000/μL

• Hemoglobin < 7 g/dL

5. Uncontrolled undercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements.

6. Known allergy to imatinib or its component products.

7. Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study.