COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04794088

Not reported

Not reported

2021-03-11

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - 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;

- 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;

2

Dr. Jurjan Aman

18

100

Netherlands

Critical disease at enrollment

8: Critical disease at enrollment

67

Change in extravascular lung water index

None

Phase 2

[{"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]