Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
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.