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Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients

NCT04794088 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-01-23

No results posted yet for this study

Summary

The SARS-CoV2 pandemic and resulting COVID-19 infection has led to a large increase in the number of patients with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterised by inflammation and fluid in the lungs. There is no proven therapy to reduce fluid leak, also known as pulmonary oedema, in ARDS. However, recent studies have discovered that imatinib strengthens the cell barrier and prevents fluid leak in the lungs in inflammatory conditions, while leaving the immune response intact. The investigators hypothesize that imatinib limits pulmonary oedema observed in ARDS due to COVID-19, and may thus help to reverse hypoxemic respiratory failure and to hasten recovery.

The hypothesis will be tested by conducting a randomised, double-blind, parallel-group, placebo-controlled multi-centre clinical study of intravenous imatinib in 90 mechanically-ventilated, adult subjects with COVID-19-related ARDS.

Study participants will receive the study drug (imatinib or placebo) twice daily for a period of 7 days. The effect of the intervention will be tested by measuring extravascular lung water (i.e. pulmonary oedema) difference between day 1 and day 4, using a PiCCO catheter (= pulse contour cardiac monitoring device).

Other measurements will include regular blood tests to investigate the safety and the pharmacokinetic properties of imatinib, as well as biomarkers of inflammation and cellular dysfunction. Furthermore, parameters of ventilation and morbidity and mortality will be recorded as secondary outcome measures.

Conditions

  • ARDS
  • Acute Respiratory Distress Syndrome
  • Covid19
  • Endothelial Dysfunction
  • Pulmonary Edema

Interventions

DRUG

Imatinib Mesylate intravenous solution

A 25ml volume of IMP will be administered over 2-hours as an intravenous infusion. This corresponds to a dose of 200mg imatinib (100mg/h).

DRUG

Placebo

A 25ml volume of IMP will be administered over 2-hours as an intravenous infusion. This corresponds to a dose of 25ml placebo (12.5ml/h).

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • Exvastat Ltd.

    collaborator INDUSTRY

  • KABS laboratories

    collaborator UNKNOWN

  • Dr. Jurjan Aman

    lead OTHER

Principal Investigators

  • Jurjan Aman, Dr. · Amsterdam Universitair Medische Centra, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-14
Primary Completion
2022-03-16
Completion
2022-04-07

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794088 on ClinicalTrials.gov