Dasatinib for the Treatment of Moderate and Severe COVID-19

• Status: Not yet recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

• Patients must have laboratory test proven COVID19 and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction [PCR]) within 14 days

• Able to sign informed consent for participation in the study

• Subject is hospitalized with one or more of the following:

• Moderate disease: peripheral capillary oxygen saturation (SpO2) >= 93% on room air with one of the following risk factors for developing severe disease: age >= 60 years, history of hypertension, diabetes mellitus, cardiac disease, chronic lung disease, obesity (calculated body mass index [BMI] >= 30 kg/m^2), and cardiovascular disease, clinical and/or radiological evidence of chest involvement, CRP > 2X upper limit of normal, doubling of CRP in 24 hours where chest findings and CRP elevation not explained by other underlying disease.

After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable:

• Severe disease:

• Respiratory rate >= 30 breaths/ minute (min)

• SpO2 < 93% while breathing room air

• Partial pressure of oxygen measurement (PaO2)/fraction of inspired oxygen (FiO2) =< 300 mmHg

• Absolute neutrophil count (ANC) > 1000 (baseline blood counts)

• Platelets > 50,000 / mmc (baseline blood counts)

• Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 5 times the upper limit of the normality

• Total bilirubin < 3 x institutional upper limit of normal (IULN)

• Creatinine < 2.5 times the upper limit of the normality

• Azithromycin allowed but if on both drugs patient should be on constant cardiovascular (CV) monitoring

• Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment/procedures being conducted

• Subject is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

• Pleural effusion > grade 2 evident on chest x-ray (CXR) or chest computed tomography (CT)

• Intubation/mechanical ventilation

• Known hypersensitivity to dasatinib

• Patient being treated with immunomodulators or anti-rejection drugs

• Known active infections or other clinical condition that contraindicate dasatinib and cannot be treated or solved according to the judgement of the clinician

• ALT/AST > 5 times the upper limit of the normality

• Total bilirubin > 3 x IULN

• Neutrophils < 1000 / mmc unless; platelets < 50,000 / mmc