COVID-19 PneumoniaRALE-CORADSNCT05047653
RALE Versus CORADS/CT-Severity Score in COVID-19
An observational study of COVID-19 Pneumonia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale Patients with severe coronavirus disease 2019 (COVID-19) frequently fulfill the criteria for acute respiratory distress syndrome (ARDS), with extensive and bilateral abnormalities on the chest radiography (CXR) and the chest computed tomography (CT) abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- RALE score vs. severity score
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Sep 2021to 1 Jan 2022
- 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: Invasive ventilated COVID-19 patients
Who may be able to join
- admitted to the intensive care unit of the Amsterdam UMC, location 'AMC', between March 1, 2020 and May 31, 2020 (the first 3 months of the first wave of the national outbreak in the Netherlands) and between October 1, 2020 and December 31, 2020 (the first 3 months of the second wave in the Netherlands);
- RT-PCR confirmed coronavirus diseases 2019 (COVID-19); and
- having had received at least one chest radiograph (CXR) and one adjacent chest computed tomography (CT) scan during the period a patient was having acute respiratory failure.
Who cannot join
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: The Prognostic Value of the Abnormalities on the Chest Radiography Versus the Chest Computed Tomography in Critically Ill COVID-19 Patients - Protocol for a National Study Comparing the RALE With the CORADS and CT-Severity Score
Rationale Patients with severe coronavirus disease 2019 (COVID-19) frequently fulfill the criteria for acute respiratory distress syndrome (ARDS), with extensive and bilateral abnormalities on the chest radiography (CXR) and the chest computed tomography (CT) abnormalities. The 'Radiographic Assessment of Lung Edema' (RALE) score, the 'COVID-19 Reporting and Data System' (CO-RADS) score, and the 'CT severity score' may all have prognostic value in critically ill patients with acute respiratory failure due to COVID-19.
Objectives To compare the prognostic value of the RALE score, the CO-RADS score and the CT severity score in critically ill patients with ARDS due to COVID-19.
Read more
Hypotheses The RALE score, the CO-RADS score and the CT severity score have prognostic value (primary). The RALE score, the CO-RADS score and the CT severity score correlate well.
Study design National, retrospective observational study. Study population Critically ill COVID-19 patients with acute respiratory failure, who received at least one CXR and one chest CT scan during critical illness.
Method CXRs are visually scored by two independent investigators, using the RALE score approach. Chest CT scans are scored by an independent radiologist, using the CO-RADS score and the CT severity score. Demographic, ventilation and outcome data are captured from the hospital systems.
Main study parameters/endpoints ICU mortality (primary) and hospital-, 28-, 90-mortality, the number of days alive and free from invasive ventilation, duration of ventilation in survivors, and length of stay in ICU and hospital.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Participants will not directly benefit from participation, but burden is absent. The CRX and chest CT scans have already been obtained as part of routine clinical care. Collecting CXR for RALE scoring and chest CT scans for CO-RADS and CT severity scoring, clinical and outcome data is of no harm for individual patients.
- Conditions
- COVID-19 Pneumonia
- Being tested
- RALE score vs. severity score
- Keywords
- RALE score, severity score, CORADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RALE score vs. severity scoreDiagnostic test
RALE score vs. severity score and CORADS
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
The ICU mortality with a maximum of 90 days
Measured: 90 days
Secondary outcomes (3)
hospital mortality
The hospital mortality with a maximum of 90 days
Measured: 90 days
28-day mortality
The 28-day mortality
Measured: 28 days
90-day mortality
The 90-day mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start14 Sep 2021
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047653
- Sponsor's protocol ID
- RALE-CORADS
- Acronym
- RALE-CORADS
- Status last verified
- Feb 2022
- First submitted
- 14 Sep 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- 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
- The Prognostic Value of the Abnormalities on the Chest Radiography Versus the Chest Computed Tomography in Critically Ill COVID-19 Patients - Protocol for a National Study Comparing the RALE With the CORADS and CT-Severity Score
- ClinicalTrials.gov ID
- NCT05047653
- Acronym / sponsor ID
- RALE-CORADS / RALE-CORADS
- Conditions
- COVID-19 Pneumonia
- Keywords
- RALE score, severity score, CORADS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Sep 2021 (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.
Rationale Patients with severe coronavirus disease 2019 (COVID-19) frequently fulfill the criteria for acute respiratory distress syndrome (ARDS), with extensive and bilateral abnormalities on the chest radiography (CXR) and the chest computed tomography (CT) abnormalities. The 'Radiographic Assessment of Lung Edema' (RALE) score, the 'COVID-19 Reporting and Data System' (CO-RADS) score, and the 'CT severity score' may all have prognostic value in critically ill patients with acute respiratory failure due to COVID-19.
Objectives To compare the prognostic value of the RALE score, the CO-RADS score and the CT severity score in critically ill patients with ARDS due to COVID-19.
Hypotheses The RALE score, the CO-RADS score and the CT severity score have prognostic value (primary). The RALE score, the CO-RADS score and the CT severity score correlate well.
Study design National, retrospective observational study. Study population Critically ill COVID-19 patients with acute respiratory failure, who received at least one CXR and one chest CT scan during critical illness.
Method CXRs are visually scored by two independent investigators, using the RALE score approach. Chest CT scans are scored by an independent radiologist, using the CO-RADS score and the CT severity score. Demographic, ventilation and outcome data are captured from the hospital systems.
Main study parameters/endpoints ICU mortality (primary) and hospital-, 28-, 90-mortality, the number of days alive and free from invasive ventilation, duration of ventilation in survivors, and length of stay in ICU and hospital.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Participants will not directly benefit from participation, but burden is absent. The CRX and chest CT scans have already been obtained as part of routine clinical care. Collecting CXR for RALE scoring and chest CT scans for CO-RADS and CT severity scoring, clinical and outcome data is of no harm for individual patients.
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
- Invasive ventilated COVID-19 patients
Key inclusion criteria (3 listed)
- admitted to the intensive care unit of the Amsterdam UMC, location 'AMC', between March 1, 2020 and May 31, 2020 (the first 3 months of the first wave of the national outbreak in the Netherlands) and between October 1, 2020 and December 31, 2020 (the first 3 months of the second wave in the Netherlands);
- RT-PCR confirmed coronavirus diseases 2019 (COVID-19); and
- having had received at least one chest radiograph (CXR) and one adjacent chest computed tomography (CT) scan during the period a patient was having acute respiratory failure.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RALE score vs. severity scoreRALE score vs. severity score and CORADS | Diagnostic test | – |
Primary outcome
ICU mortality
Time frame: 90 days
The ICU mortality with a maximum of 90 days
3 secondary outcomes
hospital mortality
Time frame: 90 days
28-day mortality
Time frame: 28 days
90-day mortality
Time frame: 90 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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A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
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Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pneumonia, 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 3 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?
ICU mortality (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 31 Oct 2026.