This phase II trial investigates how well dasatinib works in treating patients with moderate and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce the strong inflammation caused by COVID-19 that can damage the lungs or other organs.
PRIMARY OBJECTIVES: I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying. II. To determine 1 month survival. SECONDARY OBJECTIVES: I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection. II. To determine change in C-reactive protein (CRP) levels after starting therapy. III. To document activity of dasatinib in lessening cytokine release syndrome (CRS) and sequential organ failure assessment (SOFA) score. EXPLORATORY OBJECTIVES: I. Interleukin-6 /cytokine assay weekly on treatment protocol. II. Ferritin levels at study entry and every (q) 2 days on treatment protocol. III. D-dimer levels at study entry and q 2 days on treatment protocol. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dasatinib anhydrous orally (PO) once daily (QD) for 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Given PO
Given PO
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying
Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying.
Time frame: Up to 28 days
Absolute lymphocyte count
Assessment via standard blood chemistry and metabolic panel
Time frame: Baseline, during treatment (day 1-14) up to 1 month
CRP (C-reactive protein) level
Assessment via standard blood chemistry and metabolic panel
Time frame: Baseline, during treatment (day 1-14) up to 1 month
Change of the SOFA (Sequential Organ Failure Assessment)
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Time frame: Baseline, during treatment (day 1-14) up to 1 month
Number of participants with treatment-related side effects
Outcome reported as the number of adverse events and serious adverse events that occurred.
Time frame: During treatment and up to 30 days after the last treatment dose
Radiological response
Will be evaluated by chest x-ray or pulmonary computed tomography (CT)
Time frame: Baseline (optional), after seven days and if clinically indicated(up to 1 month)
Duration of hospitalization
Outcome reported as the duration of hospitalization of patients
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Time frame: From baseline up to patient's discharge (up to 1 month)
Remission of respiratory symptoms
Time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation.
Time frame: Up to 1 month
Remission of respiratory symptoms
Time to definitive extubation calculated from intubation (any time occurred) to extubation in days.
Time frame: Up to 1 month
Remission of respiratory symptoms
Time to independence from oxygen therapy in days.
Time frame: Up to 1 month