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

NCT04422678 | Unknown Phase 3 DMC

• 1 other identifier: Alex CCM 2020/5
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Keywords

SARS-CoV-2; Pneumonia; ARDS; Cytokine Storm

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: Disease Progression

  Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.

  30 Days

Secondary Outcomes (7)

• Improvement in Hypoxic Index

  From inclusion to 30 days follow up

• Hospital Length of Stay

  From inclusion to 30 days follow up

• Days on invasive mechanical ventilation

  From inclusion to 30 days follow up

• Inflammatory Markers

  From inclusion to 30 days

• Viral clearance

  From inclusion to 30 days

Study Arms (3)

Imatinib Standard Dose

EXPERIMENTAL

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

Imatinib Low Dose

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Drug: Standard of Care

Interventions

Imatinib Mesylate DRUG

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

Also known as: Imatinib

Imatinib Low Dose; Imatinib Standard Dose

Standard of Care DRUG

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

Also known as: Standard

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Science, Technology & Innovation Funding Authority (STIFA), Egypt: collaborator

MeSH Terms

Conditions

COVID-19; Pneumonia; Cytokine Release Syndrome

Interventions

Imatinib Mesylate; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hany ASSAAD, MD, PhD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASSAAD, MD, PhD

CONTACT

00201223125575; samir.assaadkhalil@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share