This phase III trial compares imatinib with placebo in treating hospitalized adults with COVID-19 infection. Imatinib is an enzyme inhibitor and may have some antiviral activities. This trial aims to see whether adding imatinib to the best conventional care may help improve outcomes of hospitalized adult patients with COVID-19 infection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04394416.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy and safety of oral administration of imatinib mesylate (imatinib) combined with best conventional care (BCC) versus (vs.) placebo plus BCC in hospitalized patients with human coronavirus 2019 infection (COVID-19).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive imatinib mesylate orally (PO) daily for 14 days in the absence of unacceptable toxicity. Patients also receive BCC.
ARM II: Patients receive placebo PO daily for 14 days in the absence of unacceptable toxicity. Patients also receive BCC.
After completion of study treatment, patients are followed up at 60 days.
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorAndrea R. Levine