Status:
WITHDRAWN
Dasatinib for the Treatment of Moderate and Severe COVID-19
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Symptomatic COVID-19 Infection Laboratory-Confirmed
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 in...
Detailed Description
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 OBJ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04830735
Start Date
August 5 2022
End Date
December 15 2024
Last Update
August 10 2022
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033