mandatory

[키워드] 24 hours active malignancy acute kidney Acute kidney injury acute respiratory distress syndrome addition Administered administration adverse event adverse events AEs age Alpha alpha-1 antitrypsin Amendment Anti-viral Antibiotics anticipated antitrypsin antivirals approval approved ARDS ARMS authority bacterial pneumonia baseline Berlin criteria blinded to treatment Blinding BMI body weight Cancer changes in Child-Pugh score chloride Chronic kidney disease chronic liver disease circulating class clinical Clinical outcome clinical trial Combination commenced Committee comparator Complete conducted Consent Controlled trial correction COVID-19 Culture cytokine level cytokine levels Data collection defined determine Diagnosis diagnosis of ARDS dialysis dissemination DNAR double-blind Echocardiogram Effect Effectiveness elapsed element ELISA enrolled EudraCT excluded exclusion exclusion criteria facilitate Follow-up followed by for inclusion group Health Products regulatory Authority hospital Hospital admission hypertension ICU IgA deficiency IL-10 IL-1β IL-6 IL-8 incidence inclusion criteria individual information intensive care unit intensive care units interim analysis interleukin interleukin-10 interleukin-1β interleukin-6 interleukin-8 interpreter Intervention intravenous intravenous infusion intravenously invasive investigational medicinal product investigator Ireland Kidney disease Laboratory laboratory-confirmed life Local maintain major trauma malignancy mandatory marker mechanical ventilation Microscopy moderate moderate to severe Mortality Non-invasive non-invasive mechanical ventilation non-invasive ventilation number objective occur Organ failure outcome outcome measure PaO participant Patient patient recruitment patients with moderate PCR-confirmed Phase 2 physician Placebo placebo-controlled plasma plasma analysis plasma concentration plasma concentrations pregnant preparation product protocol provided Pulmonary embolism pulmonary hypertension purified Radiographic randomisation randomisation list randomised randomised controlled trial rationale readmission REC receiving receptor recruited recruitment reduce Regulatory removal renal renal replacement therapy replacement therapy reported required Research Research Ethics Research Ethics Committee research nurse research nurses respiratory respiratory distress Respiratory distress syndrome resulting Resuscitation SAE SAEs Sample size SARS-CoV-2 secondary secondary bacterial pneumonia Secondary objective Secondary objectives Secondary outcomes secretion Sequential Organ Failure Assessment Serious Adverse Event Serious Adverse Events severe ARDS Shock single dose skin cancer Sodium chloride SOFA Standard statistician stratified study participation Study protocol subject submitted supplementary material Support sustained TNF TNF-α Tolerability trauma Treatment treatment allocation Trial trial protocol Trial registration vasopressors ventilator verbal Version Volume website WHO Withdrawal writing
[DOI] 10.1186/s13063-021-05254-0 PMC 바로가기 [Article Type] Letter