A Phase I/II Clinical Trial to evaluate the efficacy of baricitinib to prevent respiratory insufficiency progression in onco-hematological patients affected with COVID19: A structured summary of a study protocol for a randomised controlled trial
COVID19에 감염된 종양-혈액학적 환자에서 호흡 부전 진행을 예방하기 위한 바리시티닙의 효능을 평가하기 위한 I/II상 임상 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약
Letter
[키워드] 1:1
AAK1
absence
activator
Acute respiratory failure
Administered
administration
Adverse
adverse events
affected
alkaline phosphatase
All participants
allergy
Alpha
alpha error
angina pectoris
Antibiotics
appearance
ARDS
Arm
assigned
AST/ALT
Baricitinib
baseline
beta error
Bilirubin
Blinding
Blood
Breastfeeding
can be used
candidate
Candidates
capture
Cardiac arrhythmia
carried
change
clearance
clinical
clinical condition
clinical suspicion
clinical trials
Coagulation
Cohort
Common Terminology Criteria
Comorbidity
Complete
completion
Compliance
congestive heart failure
control arm
Controlled trial
corticoid
Corticosteroids
COVID19
creatinine
creatinine clearance
CRP
D-dimer
Day
Deep venous thrombosis
description
Deterioration
Dexamethasone
dimer
discharge
discretion
disease
dissemination
diverticulitis
dose
dropout rate
Duration of therapy
ECMO
Efficacy
electronic case report form
element
eligibility criteria
Enrollment
evaluate
exclusion criteria
expected
experimental arm
extracorporeal membrane oxygenation
febrile neutropenia
ferritin
followed by
form
fraction
Gas exchange
greater
HBV
HCV
hemodynamic instability
High-flow nasal cannula
HIV
HIV infection
ICU
immobilization
immunological
impossibility
incidence
include
indication
Infection
infection with SARS-CoV-2
Inflammatory response
interfere
interferon
Interim
interim analysis
interleukin
interleukin 6
interstitial pneumonia
Intervention
intestinal perforation
Invasive mechanical ventilation
investigational agent
investigator
jak inhibitors
Jak-STAT
Laboratory
laboratory parameter
Laboratory parameters
LDH
less
limit
limits
management
mechanical ventilation
medical history
Medicine
meet
Methylprednisolone
Mild ARDS
Mortality
multi organ failure
nasal
nasal cannula
need for oxygen
neutropenia
neutrophil
Neutrophils
Non-invasive
number
objective
on mechanical ventilation
oncological patients
onset of symptom
open
open label
oral medication
organ dysfunction
Organ failure
outcome
oxygen
oxygen support
PaFi
participant
Participants
Participation
pathogen
Pathogens
pathway
Patient
patients
performance status
performed
phase
Phase 1
Phase 2
Phase I
phosphatase
platform
Pneumonia
poor prognosis
positive
Prednisone
pregnancy test
pregnant
prejudice
Prevent
progression
Prophylaxis
Protein
protein kinase
protocol
Psychiatric
psychiatric illness
Pulmonary embolism
radiological
randomisation
randomised
randomised controlled trial
randomization
Randomized
Randomized controlled trial
receive
receptor
recruitment
REDCap
REDcap platform
reduce
reduced
Remdesivir
removal
report
reported
required
respiratory
Respiratory failure
Respiratory function
respiratory insufficiency
respiratory tract
Sample size
SARS-CoV-2
SARS-CoV2
SARS-CoV2 infection
Secondary objectives
Sepsis
severe adverse event
severe adverse events
severe pneumonia
severe respiratory failure
Spain
Spanish
Standard of care
STAT
status
study enrollment
Study protocol
supplemental oxygen requirement
supplemental oxygen requirements
supplementary material
Support
surgical
surgical intervention
Symptom
symptomatic
Tablet
Therapies
therapy
thromboembolic disease
thrombosis
Tocilizumab
total bilirubin
Toxicity
Transcription
transducer
Treatment
treatment period
Trial
unstable angina
use of corticosteroid
Venous thrombosis
Version
viral endocytosis
website
Withdrawal
worsening
[DOI] 10.1186/s13063-021-05072-4 PMC 바로가기 [Article Type] Letter
[DOI] 10.1186/s13063-021-05072-4 PMC 바로가기 [Article Type] Letter