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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Imatinib Mesylate; Drug: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Imatinib Mesylate; Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.; Other Names: Imatinib
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).	Drug: Imatinib Mesylate; Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.; Other Names: Imatinib
ACTIVE_COMPARATOR: Control; Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).	Drug: 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.; Other Names: Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint: Disease Progression	Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Hypoxic Index	Improvement of Hypoxic index( PaO2 / FiO2) calculated daily	From inclusion to 30 days follow up
Hospital Length of Stay	Hospital Length of stay	From inclusion to 30 days follow up
Days on invasive mechanical ventilation	Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation	From inclusion to 30 days follow up
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
Viral clearance	Rate of viral clearance as monitored by SARS-COV-2 PCR	From inclusion to 30 days
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
Safety of Imatinib	Rate of serious adverse events (SAEs)	From inclusion to 60 days

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Science, Technology & Innovation Funding Authority (STIFA), Egypt
• Investigators: Principal Investigator: Hany ASSAAD, MD, PhD, University of Alexandria

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Pneumonia; ARDS; Cytokine Storm
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: Alex CCM 2020/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No