COVID-19NCT05490914
The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test
An observational study of COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Experimental Group：COVID-19 case Control Group：Healthy population without COVID-19
Who may be able to join
- Adult >20 years old
- Retrospective cohort by medical chart review：COVID-19 patients, Influenza patients, and SARS patients at NTUH
- Prospective cohort：COVID-19 confirmed patients intubated and receiving mechanical ventilation > 24 hours at NTUH, got extubated and discharged
Who cannot join
- Pregnancy
- No consent/inability to obtain consent or appropriate legal representative not available
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Conditions
- COVID-19
- Keywords
- COVID-19, ARDS, Lung mechanics, Ventilation strategy, Lung mechanics&function
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | COVID-19 case | |
| Control Group | Healthy population without COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of the retrospective cohort
liberation from mechanical ventilation/ventilator dependency on ventilation day 28
Measured: on ventilation day 28
Primary Outcome of the retrospective cohort
ICU and in-hospital mortality
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jul 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490914
- Sponsor's protocol ID
- 202005059RIND
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test
- ClinicalTrials.gov ID
- NCT05490914
- Acronym / sponsor ID
- 202005059RIND
- Conditions
- COVID-19
- Keywords
- COVID-19, ARDS, Lung mechanics, Ventilation strategy, Lung mechanics&function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –COVID-19 case |
| Control Group | – | –Healthy population without COVID-19 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experimental Group：COVID-19 case Control Group：Healthy population without COVID-19
Key inclusion criteria (3 listed)
- Adult >20 years old
- Retrospective cohort by medical chart review：COVID-19 patients, Influenza patients, and SARS patients at NTUH
- Prospective cohort：COVID-19 confirmed patients intubated and receiving mechanical ventilation > 24 hours at NTUH, got extubated and discharged
Key exclusion criteria (2 listed)
- Pregnancy
- No consent/inability to obtain consent or appropriate legal representative not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome of the retrospective cohort
Time frame: on ventilation day 28
liberation from mechanical ventilation/ventilator dependency on ventilation day 28
Primary Outcome of the retrospective cohort
Time frame: through study completion, an average of 1 year
ICU and in-hospital mortality
1 secondary outcome
Outcome of the prospective cohort: pulmonary function test will be performed daily by the patients after discharge from NTUH
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Chung Shu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome of the retrospective cohort (time frame: on ventilation day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.