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

COVID-19 Clinical Trial

Official title:

Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04422678
• Other study ID #: Alex CCM 2020/5
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2020
• Est. completion date: October 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: ASSAAD, MD, PhD
• Phone: 00201223125575
• Email: samir.assaadkhalil[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Imatinib Mesylate
Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
• Standard of Care
Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	Science, Technology & Innovation Funding Authority (STIFA), Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Disease Progression	Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.	30 Days
Secondary	Improvement in Hypoxic Index	Improvement of Hypoxic index( PaO2 / FiO2) calculated daily	From inclusion to 30 days follow up
Secondary	Hospital Length of Stay	Hospital Length of stay	From inclusion to 30 days follow up
Secondary	Days on invasive mechanical ventilation	Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation	From inclusion to 30 days follow up
Secondary	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
Secondary	Viral clearance	Rate of viral clearance as monitored by SARS-COV-2 PCR	From inclusion to 30 days
Secondary	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
Secondary	Safety of Imatinib	Rate of serious adverse events (SAEs)	From inclusion to 60 days