Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial
Date
2020-10-28Journal
TrialsPublisher
Springer NatureType
Article
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Show full item recordAbstract
Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO2 ≤92% on ambient air or PaO2/FiO2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy.Keyword
COVID-19Randomised controlled trial
SARS-CoV
TKI
TKI-induced attenuation of vascular leak
TKI-induced prevention and treatment lung inflammation
imatinib
lysosomal sequestration
protocol
tyrosine kinase inhibitor
viral ABL-1 signalling
Identifier to cite or link to this item
http://hdl.handle.net/10713/14022ae974a485f413a2113503eed53cd6c53
10.1186/s13063-020-04819-9
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