Intravenous imatinib for corona virus-related lung injury.

Phase 1

• Conditions: COVID-19 related Acute Respiratory Distress Syndrome (ARDS) in mechanically-ventilated patients on the Intensive Care Unit.; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005447-23-NL
• Lead Sponsor: Amsterdam Universitair Medische Centra, location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age = 18 years;
2. Moderate-severe ARDS, as defined by Berlin definition for ARDS, 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;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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 µg/kg/min) for > 6 hours;
2. Pre-existing chronic pulmonary disease, including: o Known diagnosis of Interstitial Lung disease
o Known diagnosis of COPD Gold IV or FEV1<30%pred o DLCO <45% (if test results are available)
o Total lung capacity (TLC) < 60% of predicted (if test results are available);
3. Chronic home oxygen treatment;
4. Pre-existing heart failure with a known left ventricular ejection
fraction <40%;
5. Active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year;
6. Currently receiving extracorporeal life support (ECLS);
7. Severe chronic liver disease with Child-Pugh score > 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 study drug administration within 48 hours of screening;
10. Known to be pregnant or breast-feeding;
11. Enrolled in a concomitant clinical trial of an investigational
medicinal product;
12. White blood count < 2.5x109/l;
13. Haemoglobin < 4.0 mmol/l;
14. Thrombocytes < 50x109/l;
15. The use of strong CYP3A4 inducers, including the following drugs:
Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified