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

NCT ID: NCT04422678

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2020-10-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.

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).

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.

Control

Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.

Interventions

Imatinib Mesylate

Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Imatinib; Standard

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Science, Technology & Innovation Funding Authority (STIFA), Egypt

UNKNOWN

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hany ASSAAD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Central Contacts

ASSAAD, MD, PhD

Role: CONTACT

samir.assaadkhalil@alexmed.edu.eg

00201223125575

Other Identifiers

Alex CCM 2020/5

Identifier Type: -

Identifier Source: org_study_id