Clinical trial NCT04422678: The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
Official title: Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: SARS-CoV-2
Pneumonia
ARDS
Cytokine Storm
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Science, Technology & Innovation Funding Authority (STIFA), Egypt
First posted: 2020-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint: Disease Progression
timeFrame: 30 Days
Secondary outcomes:
measure: Improvement in Hypoxic Index
timeFrame: From inclusion to 30 days follow up
measure: Hospital Length of Stay
timeFrame: From inclusion to 30 days follow up
measure: Days on invasive mechanical ventilation
timeFrame: From inclusion to 30 days follow up
measure: Inflammatory Markers
timeFrame: From inclusion to 30 days
measure: Viral clearance
timeFrame: From inclusion to 30 days
measure: Radiological assessment
timeFrame: From inclusion to 30 days
measure: Safety of Imatinib
timeFrame: From inclusion to 60 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Alexandria
name: Hany ASSAAD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: