The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Imatinib Standard Dose
Imatinib Low Dose
Control
Arm 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).
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 for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
Outcomes
Primary Outcome Measures
Primary endpoint: Disease Progression
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
Secondary Outcome Measures
Improvement in Hypoxic Index
Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Hospital Length of Stay
Hospital Length of stay
Days on invasive mechanical ventilation
Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation
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
Viral clearance
Rate of viral clearance as monitored by SARS-COV-2 PCR
Radiological assessment
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
Rate of serious adverse events (SAEs)
Full Information
NCT ID
NCT04422678
First Posted
June 5, 2020
Last Updated
June 8, 2020
Sponsor
Alexandria University
Collaborators
Science, Technology & Innovation Funding Authority (STIFA), Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04422678
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
Collaborators
Science, Technology & Innovation Funding Authority (STIFA), Egypt
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imatinib Standard Dose
Arm Type
Experimental
Arm 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).
Arm Title
Imatinib Low Dose
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
Intervention Type
Drug
Intervention Name(s)
Imatinib Mesylate
Other Intervention Name(s)
Imatinib
Intervention Description
Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Standard
Intervention Description
Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
Primary Outcome Measure Information:
Title
Primary endpoint: Disease Progression
Description
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Improvement in Hypoxic Index
Description
Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Time Frame
From inclusion to 30 days follow up
Title
Hospital Length of Stay
Description
Hospital Length of stay
Time Frame
From inclusion to 30 days follow up
Title
Days on invasive mechanical ventilation
Description
Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation
Time Frame
From inclusion to 30 days follow up
Title
Inflammatory Markers
Description
Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
Time Frame
From inclusion to 30 days
Title
Viral clearance
Description
Rate of viral clearance as monitored by SARS-COV-2 PCR
Time Frame
From inclusion to 30 days
Title
Radiological assessment
Description
Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
Time Frame
From inclusion to 30 days
Title
Safety of Imatinib
Description
Rate of serious adverse events (SAEs)
Time Frame
From inclusion to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ASSAAD, MD, PhD
Phone
00201223125575
Email
samir.assaadkhalil@alexmed.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany ASSAAD, MD, PhD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
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