Covid19NCT04485338
Chest Radiography in COVID-19 Patients
An observational study of Covid19, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 139 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2020to 1 Sep 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.
Who may be able to join
- Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020
- Having had received invasive ventilation
- Having had received at least one chest radiograph under invasive ventilation
- Confirmed novel coronavirus diseases (COVID-19)
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Assessment of Lung Edema in Invasively Ventilated COVID-19 Patients (RALE-COVID) - Protocol for an International Multicenter Retrospective Study
To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.
- Conditions
- Covid19
- Keywords
- Chest radiography, RALEscore, Radiographic Assessment of Lung Edema, ICU, invasively ventilated
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.
Measured: 90 days
Secondary outcomes (2)
The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19
Measured: 90 days
Number of ventilator-free day and alive at day 28 (VFD)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro, Mahidol University, Universitair Ziekenhuis Brussel, Chonburi hospital
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J. Schultz, Prof., Principal investigator, Amsterdam University Medical Centers, location 'AMC'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485338
- Sponsor's protocol ID
- RALE-COVID
- Status last verified
- Feb 2022
- First submitted
- 23 Jul 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Lung Edema in Invasively Ventilated COVID-19 Patients (RALE-COVID) - Protocol for an International Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04485338
- Acronym / sponsor ID
- RALE-COVID
- Conditions
- Covid19
- Keywords
- Chest radiography, RALEscore, Radiographic Assessment of Lung Edema, ICU, invasively ventilated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University of Bari Aldo Moro, Mahidol University, Universitair Ziekenhuis Brussel, Chonburi hospital
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Jul 2020 (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.
To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.
Key inclusion criteria (4 listed)
- Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020
- Having had received invasive ventilation
- Having had received at least one chest radiograph under invasive ventilation
- Confirmed novel coronavirus diseases (COVID-19)
Key exclusion criteria (1 listed)
- Age < 18 years
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
The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.
Time frame: 90 days
2 secondary outcomes
The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19
Time frame: 90 days
Number of ventilator-free day and alive at day 28 (VFD)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marcus J. Schultz, Prof. principal investigator
Amsterdam University Medical Centers, location 'AMC'
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 Covid19, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Feb 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19. (time frame: 90 days). 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 16 Feb 2022; AzTrials last refreshed its copy on 3 Nov 2026.