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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422678
Recruitment Status : Unknown
Verified June 2020 by Alexandria University.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Science, Technology & Innovation Funding Authority (STIFA), Egypt
Information provided by (Responsible Party):
Alexandria University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Imatinib Mesylate Drug: Standard of Care Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Standard


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


Secondary Outcome Measures :
  1. Improvement in Hypoxic Index [ Time Frame: From inclusion to 30 days follow up ]
    Improvement of Hypoxic index( PaO2 / FiO2) calculated daily

  2. Hospital Length of Stay [ Time Frame: From inclusion to 30 days follow up ]
    Hospital Length of stay

  3. Days on invasive mechanical ventilation [ Time Frame: From inclusion to 30 days follow up ]
    Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation

  4. Inflammatory Markers [ Time Frame: From inclusion to 30 days ]
    Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups

  5. Viral clearance [ Time Frame: From inclusion to 30 days ]
    Rate of viral clearance as monitored by SARS-COV-2 PCR

  6. Radiological assessment [ Time Frame: From inclusion to 30 days ]
    Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)

  7. Safety of Imatinib [ Time Frame: From inclusion to 60 days ]
    Rate of serious adverse events (SAEs)


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422678


Contacts
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Contact: ASSAAD, MD, PhD 00201223125575 samir.assaadkhalil@alexmed.edu.eg

Sponsors and Collaborators
Alexandria University
Science, Technology & Innovation Funding Authority (STIFA), Egypt
Investigators
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Principal Investigator: Hany ASSAAD, MD, PhD University of Alexandria
More Information
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Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT04422678    
Other Study ID Numbers: Alex CCM 2020/5
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alexandria University:
SARS-CoV-2
Pneumonia
ARDS
Cytokine Storm
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
 Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action