SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion
SPIKE-1: SARS-CoV-2 스파이크 단백질 개시 막 융합을 차단하여 COVID-19의 임상 진행을 줄이는 데 camostat의 사용을 평가하는 커뮤니티 환경에서의 무작위 2상/3상 시험
Letter
[키워드] 1:1
acute respiratory syndrome coronavirus
apyrexia
available data
baseline
best
Biomarkers
Blinding
camostat
clearance
Clinical improvement
clinical trial
Community
conducted
control arm
coronavirus
coronavirus 2
coronavirus disease
Coronavirus disease 2019
COVID-19
COVID-19 infection
COVID-19 symptom
COVID-19 symptoms
COVID-2019
Day
defined
Deterioration
determined by
diagnostics
disease
dissemination
duration of illness
Efficacy
element
eligibility criteria
Eligible patients
EudraCT
evaluate
Evidence
evidence of
Formal
four times daily
functional
Guidance
Health Organization
health protection
high risk
hospital
Hospital admission
Hospital admissions
Host
include
Infection
initial
Interactive Web Response System
interim analysis
Ireland
IWRS
Laboratory testing
maximum
membrane fusion
moderate
Mortality
multicentre
nasal
negative swab
number
objective
open
open label
Open-label
Ordinal Scale
outcome
outcome measure
overall mortality
oxygen
oxygen-free day
Oxygenation
participant
Patient
patient population
patients with SARS-CoV-2
performed
phase
PK data
Prevent
primary care
progression
protection
protocol
provided
Public
Public Health Agency
Public Health England
qPCR
questionnaire
randomisation
randomised
randomised controlled trial
receive
recruit
recruited
recruitment
reduce
reducing
refinement
requiring supplemental oxygen
Research
respiratory
risk
RT-PCR
Saliva
Sample size
Sample size calculations
SARS-CoV-2
SARS-COV-2 infection
secondary
Secondary objective
Secondary objectives
secondary outcome measures
serum antibody
Severe acute respiratory syndrome
severe acute respiratory syndrome coronavirus 2
severity
spike
status
supplemental oxygen
supplementary material
supplementary oxygen
supportive care
Swab
symptom severity
tablets
temperature
the patient
TMPRSS2
translational
Translational research
Treatment
treatment arm
Trial
trial protocol
Trial registration
typical symptom
typical symptoms
upper respiratory
Ventilation
ventilator
ventilator-free day
Ventilator-free days
Viral
Viral load
viral shedding
website
World Health Organization
[DOI] 10.1186/s13063-021-05461-9 PMC 바로가기 [Article Type] Letter
[DOI] 10.1186/s13063-021-05461-9 PMC 바로가기 [Article Type] Letter