harmonization

[키워드] 1:1 24 hour Ability absence accompany activity Administered administration Admission adverse events Affect age alkaline phosphatase allergy ALT alternative hypothesis ambient Analysis ANC Anti-inflammatory anticipated antipyretics antivirals Arm ARMS assumed AST Baltimore baseline benefit blinded block block randomization Blood breastfeeding women Bronchoalveolar lavage calculated Care Cellulose center Chest chest X-ray childbearing potential clinical clinical condition Clinical course clinical impact Clinical improvement Clinical outcome clinical status clinical trial collected competing Compliance concealed Concentration Concomitant conditions conducted congestive heart failure Contraception Control control arm Conventional Corticosteroids COVID-19 COVID-19 disease COVID-19 infection COVID-19 pandemic criteria criterion Critical CT scan current Day Declaration of Helsinki decrease defined detect direct bilirubin disease disorder dissemination dose double-blind drug Drug administration drug-drug interaction drugs Duration ECMO Efficacy Efficacy and safety element eligible endosomal pH Enrollment ethnic group evaluate Evidence exclusion expected exploratory endpoint extracorporeal membrane oxygenation Face mask FDA Fisher Good group handling harmonization hematologic histocompatibility complex Hospitalization Hospitalized hospitalized patient Hydroxychloroquine Hypothesis ICU IL-6 levels Imatinib immunomodulatory immunomodulatory drugs IND information Informed consent inhibitory activity intensive care intensive care unit intention to treat interfere International Conference invasive Invasive mechanical ventilation investigational agent investigator ITT Laboratory Last limit limitation liver Local lysosomal sequestration magnitude matching placebo mechanical ventilation men and women MHC mononuclear cell Mortality nasal nasopharyngeal Nasopharyngeal swab neutrophil count New new oxygen use non-invasive ventilation non-rebreather mask not blinded null hypothesis number objective off-label off-label use Oropharyngeal outcome outcomes oxygen Oxygenation P450 packaged PaO participant Participants Patient patients patients with ARDS patients with COVID-19 PBMCs performed Pharmacist Pharmacy phase 3 study Placebo placebo-controlled Pneumonia positive COVID-19 Practice primary analysis primary endpoint principal progression proportion protocol Psychiatric Radiographic random number generator randomised controlled trial randomization Randomized Randomized controlled trial receive receiving recruitment Regulatory renal dysfunction renal replacement therapy replication of SARS-CoV-2 required requiring supplemental oxygen Respiratory illness respiratory tract risk RT-PCR Safety Sample size sarilumab SARS-CoV SARS-CoV-2 secondary endpoint Seizure Serious Adverse Events service severe disease severity significance level Site Society stability Standard of care status stratified study drug study enrollment study outcomes Study protocol subject submitted supplemental oxygen Support Suspension symptomatic Tablet temperature Test the patient the primary endpoint time TKI TKI-induced attenuation of vascular leak TKI-induced prevention and treatment lung inflammation Tocilizumab transcriptomics Treatment treatment allocation treatment arm treatments for COVID-19 Trial two-sided tyrosine kinase inhibitor uncontrolled university unstable angina vasopressors ventilator ventilator free days viral ABL-1 signalling website with COVID-19
[DOI] 10.1186/s13063-020-04819-9 PMC 바로가기 [Article Type] Letter