The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
- Registration Number
- NCT04422678
- Lead Sponsor
- Alexandria University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Patients with PCR positive for SARS-COV-2
- Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
- Informed consent explained & signed by patient or his 1st degree relatives or legally authorized representative.
- Pregnant women (or) breast feeding women
- Patients younger than 18 years of age
- Patients with known allergy to imatinib
- Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN).
- Creatinine clearance (CrCl) < 30 mL/minute.
- Patient already on mechanical ventilation at time of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imatinib Standard Dose Imatinib Mesylate Imatinib 400 mg oral tablet once daily for 21 days In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). Control Standard of Care Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). Imatinib Low Dose Imatinib Mesylate Imatinib 200 mg oral tablet once daily for 21 days. In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
- Primary Outcome Measures
Name Time Method Primary endpoint: Disease Progression 30 Days Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay From inclusion to 30 days follow up Hospital Length of stay
Improvement in Hypoxic Index From inclusion to 30 days follow up Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Radiological assessment From inclusion to 30 days Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
Days on invasive mechanical ventilation From inclusion to 30 days follow up Days on mechanical ventilation for patients needing intubation \& invasive mechanical ventilation
Inflammatory Markers From inclusion to 30 days Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
Viral clearance From inclusion to 30 days Rate of viral clearance as monitored by SARS-COV-2 PCR
Safety of Imatinib From inclusion to 60 days Rate of serious adverse events (SAEs)