A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial
SARS-CoV-2 유발 급성 호흡곤란 증후군에 대한 정맥내 혈장 정제 알파-1 항트립신의 무작위 이중 맹검 위약 대조 파일럿 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약
Letter
[키워드] 24 hours
active malignancy
acute kidney
Acute kidney injury
acute respiratory distress syndrome
addition
Administered
administration
adverse event
adverse events
AEs
age
Alpha
alpha-1 antitrypsin
Amendment
Anti-viral
Antibiotics
anticipated
antitrypsin
antivirals
approval
approved
ARDS
ARMS
authority
bacterial pneumonia
baseline
Berlin criteria
blinded to treatment
Blinding
BMI
body weight
Cancer
changes in
Child-Pugh score
chloride
Chronic kidney disease
chronic liver disease
circulating
class
clinical
Clinical outcome
clinical trial
Combination
commenced
Committee
comparator
Complete
conducted
Consent
Controlled trial
correction
COVID-19
Culture
cytokine level
cytokine levels
Data collection
defined
determine
Diagnosis
diagnosis of ARDS
dialysis
dissemination
DNAR
double-blind
Echocardiogram
Effect
Effectiveness
elapsed
element
ELISA
enrolled
EudraCT
excluded
exclusion
exclusion criteria
facilitate
Follow-up
followed by
for inclusion
group
Health Products regulatory Authority
hospital
Hospital admission
hypertension
ICU
IgA deficiency
IL-10
IL-1β
IL-6
IL-8
incidence
inclusion criteria
individual
information
intensive care unit
intensive care units
interim analysis
interleukin
interleukin-10
interleukin-1β
interleukin-6
interleukin-8
interpreter
Intervention
intravenous
intravenous infusion
intravenously
invasive
investigational medicinal product
investigator
Ireland
Kidney disease
Laboratory
laboratory-confirmed
life
Local
maintain
major trauma
malignancy
mandatory
marker
mechanical ventilation
Microscopy
moderate
moderate to severe
Mortality
Non-invasive
non-invasive mechanical ventilation
non-invasive ventilation
number
objective
occur
Organ failure
outcome
outcome measure
PaO
participant
Patient
patient recruitment
patients with moderate
PCR-confirmed
Phase 2
physician
Placebo
placebo-controlled
plasma
plasma analysis
plasma concentration
plasma concentrations
pregnant
preparation
product
protocol
provided
Pulmonary embolism
pulmonary hypertension
purified
Radiographic
randomisation
randomisation list
randomised
randomised controlled trial
rationale
readmission
REC
receiving
receptor
recruited
recruitment
reduce
Regulatory
removal
renal
renal replacement therapy
replacement therapy
reported
required
Research
Research Ethics
Research Ethics Committee
research nurse
research nurses
respiratory
respiratory distress
Respiratory distress syndrome
resulting
Resuscitation
SAE
SAEs
Sample size
SARS-CoV-2
secondary
secondary bacterial pneumonia
Secondary objective
Secondary objectives
Secondary outcomes
secretion
Sequential Organ Failure Assessment
Serious Adverse Event
Serious Adverse Events
severe ARDS
Shock
single dose
skin cancer
Sodium chloride
SOFA
Standard
statistician
stratified
study participation
Study protocol
subject
submitted
supplementary material
Support
sustained
TNF
TNF-α
Tolerability
trauma
Treatment
treatment allocation
Trial
trial protocol
Trial registration
vasopressors
ventilator
verbal
Version
Volume
website
WHO
Withdrawal
writing
[DOI] 10.1186/s13063-021-05254-0 PMC 바로가기 [Article Type] Letter
[DOI] 10.1186/s13063-021-05254-0 PMC 바로가기 [Article Type] Letter