Trial of Imatinib for Hospitalized Adults With COVID-19

Phase 3

Active, not recruiting

• Conditions: COVID-19

• Registration Number: NCT04394416
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-5-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Inclusion Criteria<br><br>Patients may be included in the study only if they meet all of the following criteria:<br><br> 1. Ability to understand and willingness to sign a written informed consent document.<br> Informed consent must be obtained prior to participation in the study. For patients<br> who are too unwell to provide consent such as patients on invasive ventilator or<br> ECMO, Legally Authorized Representative (LAR) can sign the informed consent.<br><br> 2. Hospitalized patients = 18 years of age<br><br> 3. Positive RT-PCR assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal,<br> nasopharyngeal or BAL) by Center for Disease Control or local laboratory within 7<br> days of randomization.<br><br>Exclusion Criteria<br><br>Patients meeting any of the following criteria are not eligible for the study:<br><br> 1. Patients receiving any other investigational agents in a clinical trial. Off-label<br> use of agents such as hydroxychloroquine is not an exclusion criterion. Therapies<br> that are shown to be effective but may not be licensed can be added as an exception<br> to the exclusion criteria in order to allow for the most contemporary standard of<br> care to include emergency use authorization treatments as they become available.<br> Antivirals such as remdesivir will be permissible given the FDA authorized emergency<br> use.<br><br> 2. Pregnant or breastfeeding women.<br><br> 3. Patients with significant liver or renal dysfunction function at screen as defined<br> as:<br><br> - Direct bilirubin > 2.5 mg/dL<br><br> - AST, ALT, or alkaline phosphatase > 5 x upper limit of normal<br><br> - eGFR = 30 mL/min or requiring renal replacement therapy<br><br> 4. Patients with significant hematologic disorder at screen as defined as:<br><br> - Absolute neutrophil count (ANC) < 500/µL<br><br> - Platelet < 20,000/µL<br><br> - Hemoglobin < 7 g/dL<br><br> 5. Uncontrolled undercurrent illness including, but not limited to, symptomatic<br> congestive heart failure, unstable angina pectoris, uncontrolled active seizure<br> disorder, or psychiatric illness/social situations that per site Principal<br> Investigator's judgment would limit compliance with study requirements.<br><br> 6. Known allergy to imatinib or its component products.<br><br> 7. Any other clinical conditions that in the opinion of the investigator would make the<br> subject unsuitable for the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a two-point change using the 8-category ordinal scale

Secondary Outcome Measures

Name	Time	Method
All-Cause mortality;Time to a 2-point clinical change;Hospitalization;Duration of ECMO or invasive mechanical ventilation;Duration of ICU stay;SARS-CoV-2 negative;Negative oropharyngeal or nasopharyngeal swab;Serious adverse events (SAEs);Discontinuation due to adverse events