COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04361526

Manuel Castellà, MD PhD

mcaste@clinic.cat

2020-04-24

Not reported

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: age 18 or older positive revere transcription polymerase chain reaction (rt-pcr) for covid-19 in a respiratory track sample acute (less than 36 hours) onset of moderate to severe ards, as defined by berlin criteria: having pneumonia or worsening respiratory symptoms bilateral pulmonary infiltrates on chest imaging (x-ray of ct scan) pulmonary wedge pressure <18 mmhg or no clinical signs of left heart failure hypoxemia: arterial oxygen pressure/fraction of inspired oxygen (pao2/fio2 ratio) <200mmhg, moderate dyspnea with signs of important respiratory workload, tachypnoea >30bpm rise of inflammatory biomarkers: c-reactive protein (crp) >10 mg/l

patients with a known contraindication for anticoagulation pregnancy or breast feeding patient already included in another research study decision by a physician that involvement in the study is not in the patient's best interest failure to have patient's authorization. in case of a mechanical intubated patient, lack of authorization from a first line family member multi-organ failure patients treated with tocilizumab at the time of start filtration

2

Manuel Castellà

18

None

Spain

Severe disease at enrollment

6: Severe disease at enrollment

40

Mechanical ventilation-free days

None

Not reported

[{"arm_notes": "", "treatment_id": 370, "treatment_name": "Cytokine adsorption", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]