The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test

COVID-19 Clinical Trial

Official title:

The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05490914
• Other study ID #: 202005059RIND
• Status: Active, not recruiting
• 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
• 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 mechanics、serum 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 mechanics、serum 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adult >20 years old

2. Retrospective cohort by medical chart review:COVID-19 patients, Influenza patients, and SARS patients at NTUH

3. Prospective cohort:COVID-19 confirmed patients intubated and receiving mechanical ventilation > 24 hours at NTUH, got extubated and discharged

Exclusion Criteria:

1. Pregnancy

2. No consent/inability to obtain consent or appropriate legal representative not available

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome of the retrospective cohort	liberation from mechanical ventilation/ventilator dependency on ventilation day 28	on ventilation day 28
Primary	Primary Outcome of the retrospective cohort	ICU and in-hospital mortality	through study completion, an average of 1 year
Secondary	Outcome of the prospective cohort: pulmonary function test will be performed daily by the patients after discharge from NTUH	forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)	through study completion, an average of 1 year