Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial
COVID-19(COVID-AT)로 인한 급성 호흡 곤란 증후군 환자에서 동종 간엽 기질 세포의 효능을 평가하기 위한 이중 맹검, 무작위, 대조 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약
Letter
[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
[DOI] 10.1186/s13063-020-04964-1 PMC 바로가기 [Article Type] Letter