Serious Adverse Events

[키워드] 1:1 24 hours 7-point ordinal scale acute respiratory distress acute respiratory distress syndrome Administered administration Admission Adult patient Adult patients Adverse Adverse drug reactions AEs age All trial participants all-cause mortality allergy Allogeneic ARDS assessment assigned baseline Biomarker blinded Blinding C-reactive protein carcinoma carcinoma in situ carried cellular chain change childbearing potential Chloroquine Clinical practice clinical status clinical trial coagulation test coagulation tests conducted Control control arm Course COVID COVID-19 CRF criteria CT scan cumulative incidence current Cytokines D-dimer Day death described determined by Diagnosis disease dissemination double-blind drug Duration ECMO Efficacy Efficacy and safety element eligible End endpoints enrolment EudraCT evaluate evaluate the effect event exclusion criteria Extracorporeal extracorporeal membrane oxygenation failure ferritin fibrosis FiO2 form GRADE grade 3 greater Haemodialysis handling hemofiltration history hospital Hospitalization hydroxy ICU ICU admission IMPROVE include inclusion criteria Informed consent intravenous Intravenous administration intravenous dose intubation Invasive mechanical ventilation invasive ventilation investigational medicinal product involved laboratory confirmation laboratory-confirmed SARS-CoV-2 infection lactation LDH less Level Local Lopinavir Lopinavir/ritonavir lung disorder lymphocyte marker Mechanical mechanical ventilation Medicine Medicines Mesenchymal stromal cells moderate to severe Mortality MSC negative pregnancy test neoplasm neutrophil neutrophil counts Non-invasive number objective occur off-label opinion Ordinal Scale organ oropharyngeal swab oropharyngeal swabs Other outcome oxygen oxygen saturation Oxygen therapy PaO2 PaO2/FiO2 ratio parameters participant Patient PCR percentage Placebo polymerase chain reaction Pregnancy primary endpoint product Production profile progression protocol Pulmonary embolism pulmonary fibrosis Pulmonary function tests randomised randomised controlled trial randomization Randomized Randomly Rapid antigen tests reaction receive recruitment Registered Remdesivir report respiratory Respiratory distress syndrome Resuscitation Ritonavir SAEs Sample size SARS-COV-2 infection secondary Secondary endpoints Sequential Organ Failure Assessment Serious Adverse Events SOFA Spain specificity specimen Sponsor Standard of care status stromal cell stromal cells Study protocol subpopulations supplemental oxygen supplementary material syndrome the cell the disease the patient the primary endpoint the WHO time Tocilizumab Tolerability Treatment treatment arm treatment for COVID-19 treatment group Treatment protocol Trial trial participant Trial registration unit website women worldwide pandemic written consent
[DOI] 10.1186/s13063-020-04964-1 PMC 바로가기 [Article Type] Letter