Pregnancy

[키워드] 6 hours Acute hypoxemic respiratory failure addition Admission Adult patients adverse effect adverse event adverse events age allocation anticipated Autoimmune disease Biochemical parameters blinded Blinding blood gas blood gas analysis body weight C-reactive protein Caregivers carried chronic Chronic kidney disease clinical condition clinical development commercialization comparator compatible symptom compatible symptoms Complete completion computer conducted Confirmed Consent Control control arm control group COVID-19 COVID-19-associated thromboembolic phenomena Critically ill D-dimer daily dose Date determined by disease dissemination double-blind Efficacy and safety element enzyme EU Clinical Trial evaluate evaluate the effect exclusion criteria expected experimental arm experimental group failing organ failing organs family member ferritin Frequency gas analysis GFR greater hematologic Hemodialysis hypoxemic Hypoxemic respiratory failure ICU ICU admission impairment Inclusion inclusion criteria increase in inflammatory state Informed institutional protocols intensive care intensive care unit interleukin interleukin-6 intravenous Kidney disease legal guardian less liver enzymes maximum mechanical ventilation medical illness melatonin Mortality multi-organ failure normal range number objective Organ failure outcome parameters participant Patient patient condition patients with COVID-19 per day performed phase physician Placebo placebo-controlled randomized trial plasma Plasma levels positive RT-PCR Pregnancy pregnancy test Prevent procalcitonin Program protocol provided randomization randomization sequence Randomized Randomized controlled trial randomized placebo-controlled trial receive recruited recruitment reduced reduction Respiratory failure Sample size SARS-COV-2 infection SAS version 9.4 SAS version 9.4 statistical software secondary Secondary objectives Sequential Organ Failure Assessment severity single center single-center SOFA Spain Stage Standard-of-care statistical status study drug study group study groups study period Study protocol systemic inflammatory response Terminal surgical thromboembolic Treatment Trial Trial registration two-arm parallel Ventilator-free days website with COVID-19 worsening written Informed Consent
[DOI] 10.1186/s13063-020-04632-4 PMC 바로가기 [Article Type] Letter