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| Name | Class |
|---|---|
| Science,Technology & Innovation Funding Authority, Egypt | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib Standard Dose | Experimental | 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). |
|
| Imatinib Low Dose | Experimental | 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). |
|
| Control | Active Comparator | Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate | Drug | Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint: Disease Progression | Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Hypoxic Index | Improvement of Hypoxic index( PaO2 / FiO2) calculated daily | From inclusion to 30 days follow up |
| Hospital Length of Stay | Hospital Length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ASSAAD, MD, PhD | Contact | 00201223125575 | samir.assaadkhalil@alexmed.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hany ASSAAD, MD, PhD | University of Alexandria | Principal Investigator |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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|
| Standard of Care | Drug | Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health. |
|
|
| From inclusion to 30 days follow up |
| Days on invasive mechanical ventilation | Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation | 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 | From inclusion to 30 days |
| Viral clearance | Rate of viral clearance as monitored by SARS-COV-2 PCR | 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) | From inclusion to 30 days |
| Safety of Imatinib | Rate of serious adverse events (SAEs) | From inclusion to 60 days |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |