The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia

Alexandria University

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Drug: Standard of Care; Drug: Imatinib Mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT04422678

Alex CCM 2020/5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Imatinib Standard Dose

Experimental group

Description:

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).

Treatment:

Drug: Imatinib Mesylate

Imatinib Low Dose

Experimental group

Description:

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).

Treatment:

Drug: Imatinib Mesylate

Control

Active Comparator group

Description:

Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).

Treatment:

Drug: Standard of Care