Status:
TERMINATED
Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients
Lead Sponsor:
Dr. Jurjan Aman
Collaborating Sponsors:
Simbec-Orion Group
Exvastat Ltd.
Conditions:
ARDS
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 medica...
Detailed Description
1. INTRODUCTION 1.1 Background of ARDS due to COVID-19 The COVID-19 pandemic has led to an unanticipated increase of the number of patients with ARDS admitted to the ICU, contributing to high ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Moderate-severe ARDS, as defined by Berlin definition for ARDS (onset within 1 week of a known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules, respiratory failure not fully explained by cardiac failure or fluid overload and P/F ratio ≤200 mmHg with PEEP ≥5 cmH2O), and intubated for mechanical ventilation.
- PCR positive for SARS-CoV2 within the current disease episode.
- Provision of signed written informed consent from the patient or patient's legally authorised representative;
Exclusion
- 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;
- Pre-existing chronic pulmonary disease, including:
- Known diagnosis of Interstitial Lung disease
- Known diagnosis of COPD GOLD Stage IV or FEV1\<30% predicted
- DLCO \<45% (if test results are available)
- Total lung capacity (TLC) \< 60% of predicted (if test results are available);
- Chronic home oxygen treatment;
- Pre-existing heart failure with a known left ventricular ejection fraction \<40%;
- Active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year;
- Currently receiving extracorporeal life support (ECLS);
- Severe chronic liver disease with Child-Pugh score \> 12;
- Subjects in whom a decision to withdraw medical care is made (e.g. palliative setting);
- Inability of the ICU staff to initiate IMP administration within 48 hours of intubation;
- Known to be pregnant or breast-feeding;
- Enrolled in a concomitant clinical trial of an investigational medicinal product;
- White blood count \< 2.5x109/l;
- Haemoglobin \< 4.0 mmol/l;
- Thrombocytes \< 50x109/l;
- The use of strong CYP3A4 inducers, including the following drugs:
- Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;
Key Trial Info
Start Date :
March 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04794088
Start Date
March 14 2021
End Date
April 7 2022
Last Update
January 23 2023
Active Locations (2)
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1
Amsterdam Universitair Medische Centra, location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
2
Amsterdam Universitair Medische Centra, location AMC
Amsterdam, North Holland, Netherlands, 1105 AZ