Acute Respiratory Distress Syndrome door COVID-19
Conditions
Interventions
1:1 randomisation to either imatinib mesilate 150mg b.i.d. (administered as a 8
mg/mL solution for direct intravenous (i.v.) injection) or placebo (identical
volume of solution for direct i.v. injec
Sponsors
Amsterdam Universitair Medisch Centrum, locatie VUMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age * 18 years; 2. Moderate-severe ARDS, as defined by Berlin definition for ARDS (Table 1), and intubated for mechanical ventilation. 3. PCR positive for SARS-CoV2 within the current disease episode. 4. Provision of signed written informed consent from the patient or patient*s legally authorised representative;
Exclusion criteria
Exclusion criteria: 1. Persistent septic shock (>24h) with a Mean Arterial Pressure (MAP) * 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation and vasopressor use (norepinephrine > 0.2 *g/kg/min) for > 6 hours; 2. Pre-existing chronic pulmonary disease, including: * Known diagnosis of Interstitial Lung disease * Known diagnosis of COPD GOLD Stage IV or FEV1 12; 8. Subjects in whom a decision to withdraw medical care is made (e.g. palliative setting); 9. Inability of the ICU staff to initiate IMP administration within 24 48 hours of admission to ICUintubation; 10. Known to be pregnant or breast-feeding; 11. Enrolled in a concomitant clinical trial of an investigational medicinal product; 12. White blood count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is the change in Extra Vascular Lung Water Index (EVLWi) between baseline (Day 0) and Day 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters include change in oxygenation and ventilation parameters, length of invasive mechanical ventilation/ventilator-free days, length of ICU stay and mortality during a 28day period after randomization, as well as parameters of pathophysiology, safety, tolerability and pharmacokinetics. | — |
Countries
Netherlands
Outcome results
None listed