Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05490914 |
Other study ID # |
202005059RIND |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
April 2022 |
Source |
National Taiwan University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging infectious
disease with high transmissibility. Around 20-25% of infected individuals develop severe
COVID-19 disease requiring hospitalization and 5-8% require intubation secondary to viral
pneumonia and acute respiratory distress syndrome (ARDS). Distinct features of COVID-19 ARDS
were found since Nov 2019, including relatively normal lung mechanics, activation of the RAAS
system, selective injury of type II alveolar cells, and presence of vasodilation vessel and
micro-thrombosis. The mechanism, potential useful biomarker, and the optimal ventilation
strategies for COVID-19 ARDS need to be systematically studied. This study hypothesized that
the low-tidal volume ventilation strategy is effective in COVID-19 ARDS. We will
retrospectively review the clinical presentation, epidemiologic data, laboratory and image
examination, medication use, lung mechanicsăserum biomarker, long-term pulmonary function
test, and clinical outcomes in COVID-19 ARDS, influenza ARDS, and SARS ARDS patients. We will
also prospectively monitor the lung function of COVID ARDS patients using personal pulmonary
function devices after discharge from NTUH. The overall purpose of this study is to
investigate the prognostic indicators of COVID ARDS patients and their long-term pulmonary
function follow-up.
Description:
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging infectious
disease with high transmissibility. Around 20-25% of infected individuals develop severe
COVID-19 disease requiring hospitalization and 5-8% require intubation secondary to viral
pneumonia and acute respiratory distress syndrome (ARDS). Distinct features of COVID-19 ARDS
were found since Nov 2019, including relatively normal lung mechanics, activation of the RAAS
system, selective injury of type II alveolar cells, and presence of vasodilation vessel and
micro-thrombosis. The mechanism, potential useful biomarker, and the optimal ventilation
strategies for COVID-19 ARDS need to be systematically studied. This study hypothesized that
the low-tidal volume ventilation strategy is effective in COVID-19 ARDS. We will
retrospectively review the clinical presentation, epidemiologic data, laboratory and image
examination, medication use, lung mechanicsăserum biomarker, long-term pulmonary function
test, and clinical outcomes in COVID-19 ARDS, influenza ARDS, and SARS ARDS patients. We will
also prospectively monitor the lung function of COVID ARDS patients using personal pulmonary
function devices after discharge from NTUH. The overall purpose of this study is to
investigate the prognostic indicators of COVID ARDS patients and their long-term pulmonary
function follow-up.The SARS-CoV-2 (COVID-19) ARDS is an emerging novel devastating disease
with high mortality. Distinct features were found since Nov 2019, including relatively normal
lung mechanics, activation of the RAAS system, selective injury of type II alveolar cells,
and presence of vasodilation vessel and micro-thrombosis. The optimal ventilation strategies
for COVID-19 ARDS need to be systematically studied. The overall purpose of this study is to
investigate the prognostic indicators in COVID-19 ARDS patients.Specific Aim 1: To develop a
REDcap database of clinical and biologic information in subjects with COVID-19, and to
investigate the prognostic indicators compared with influenza and SARS ARDS patients.Specific
Aim 2: To follow up the long-term change pulmonary function test of COVID ARDS patients using
home-based personal pulmonary function test device