A randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
Primary endpoint: Disease Progression
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
Time frame: 30 Days
Improvement in Hypoxic Index
Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Time frame: From inclusion to 30 days follow up
Hospital Length of Stay
Hospital Length of stay
Time frame: From inclusion to 30 days follow up
Days on invasive mechanical ventilation
Days on mechanical ventilation for patients needing intubation \& invasive mechanical ventilation
Time frame: From inclusion to 30 days follow up
Inflammatory Markers
Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
Time frame: From inclusion to 30 days
Viral clearance
Rate of viral clearance as monitored by SARS-COV-2 PCR
Time frame: From inclusion to 30 days
Radiological assessment
Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
Time frame: From inclusion to 30 days
Safety of Imatinib
Rate of serious adverse events (SAEs)
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Time frame: From inclusion to 60 days