The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 05/31/2020 |
| Prvo podneseno: | 06/04/2020 |
| Predviđena prijava poslana: | 06/07/2020 |
| Prvo objavljeno: | 06/08/2020 |
| Posljednje ažuriranje poslano: | 06/07/2020 |
| Posljednje ažuriranje objavljeno: | 06/08/2020 |
| Stvarni datum početka studija: | 05/31/2020 |
| Procijenjeni datum primarnog završetka: | 08/31/2020 |
| Procijenjeni datum završetka studije: | 09/30/2020 |
Stanje ili bolest
Intervencija / liječenje
Drug: Imatinib Mesylate
Drug: Control
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Imatinib Standard Dose 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). | |
| Experimental: Imatinib Low Dose 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). | |
| Active Comparator: Control Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). | Drug: Control Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health. |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Ishod
Primarne mjere ishoda
1. Primary endpoint: Disease Progression [30 Days]
Sekundarne mjere ishoda
1. Improvement in Hypoxic Index [From inclusion to 30 days follow up]
2. Hospital Length of Stay [From inclusion to 30 days follow up]
3. Days on invasive mechanical ventilation [From inclusion to 30 days follow up]
4. Inflammatory Markers [From inclusion to 30 days]
5. Viral clearance [From inclusion to 30 days]
6. Radiological assessment [From inclusion to 30 days]
7. Safety of Imatinib [From inclusion to 60 days]
