COVID-19
Conditions
Keywords
SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm
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.
Interventions
DRUGImatinib Mesylate
Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
DRUGStandard of Care
Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
Sponsors
Science, Technology & Innovation Funding Authority (STIFA), Egypt
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint: Disease Progression | 30 Days | Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | From inclusion to 30 days follow up | Hospital Length of stay |
| 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 |
| 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) |
| Safety of Imatinib | From inclusion to 60 days | Rate of serious adverse events (SAEs) |
| Viral clearance | From inclusion to 30 days | Rate of viral clearance as monitored by SARS-COV-2 PCR |
Contacts
Primary ContactASSAAD, MD, PhD
Outcome results
None listed