COVID19NCT04401228
Predictive Models for Intensive Care Admission and Death of COVID-19
An observational study of COVID19 and Pneumonia, Viral, run by Clinique Saint Pierre Ottignies at 1 site in Belgium.
Trial summary
To build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19, Pneumonia, Viral, Inflammatory Response
- What is being tested?
- predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2020to 1 Jan 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: all patient with COVID 19 with viral pneumonia
Who may be able to join
- RT-PCR + SARS Cov2 pneumonia
Who cannot join
- < 18 ans -* GOLD 3 or 4 CPOD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Predictive Models for Intensive Care Admission and Death of COVID-19 Patients in a Secondary Care Hospital in Belgium.
To build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines.
The outcomes of the study are (i) admission in the Intensive Care Unit admission and (ii) death.
Read more
All patients admitted in the Emergency Department with a positive reverse transcription-polymerase chain reaction SARS-COV2 test were included in the study. Routine clinical and laboratory data were collected at their admission and during their stay. Chest X-Rays and CT-Scans were performed and analyzed by a senior radiologist.
Generalized Linear Models using a binomial distribution with a logit link function (R software version X) were used to develop predictive scores for (i) admission to ICU among emergency ward patients; (ii) death among ICU patients. A first panel of Number Models with the highest AIC (BIC) was preselected. Ten-fold cross-validation was then used to estimate the out-of-sample prediction error among these preselected models. The one with the smallest prediction error was in the end singled out .
- Conditions
- COVID19, Pneumonia, Viral, Inflammatory Response
- Being tested
- predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?
- Keywords
- COVID19, prediction scores, ICU admission, death, TRIPOD.
- Medical subject headings
- COVID-19, Pneumonia, Viral, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?Other
patients were questioned about their usual medication (Sartan, angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory drug, immunosuppressive drugs), their health condition (diabetes, hypertension, tobacco use, mental status). The Body mass index was computed.
Age, gender, caucasian/african, weight, body mass index, number of days with symptoms before hospitalization, asthenia, pyrexia, dyspnea, chest pain, digestive sign, anosmia, ageusia, confusion, Travel or contact < one month, cigarette consumption ,hypertension, diabetes, mental status, angiotensin-converting-enzyme inhibitors, Sartan, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, SpO2,Thoracic Computerized Tomography : % of lung injury, Thoracic Computerized Tomography : density of lung injury, blood type, white blood cells, neutrophils, lymphocytes, blood platelets, fibrinogen, ferritin, triglycerides, LDH, troponin, CRP. The dates of admission to ICU and death were recorded
| Study group | Role | What they receive |
|---|---|---|
| covid ICU patients | Not described Receives: Other: predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? | |
| covid conventionnal ward | Not described Receives: Other: predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? |
What is being measured
The primary outcome is the main question the study is designed to answer.
admission to ICU
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
death
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 posted26 May 2020
- Study start1 Mar 2020
- Primary completion1 May 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Pierre Ottignies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Parisi, Clinique Saint Pierre Ottignies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401228
- Sponsor's protocol ID
- 0410508057
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rubin GD, Ryerson CJ, Haramati LB, Sverzellati N, Kanne JP, Raoof S, Schluger NW, Volpi A, Yim JJ, Martin IBK, Anderson DJ, Kong C, Altes T, Bush A, Desai SR, Goldin J, Goo JM, Humbert M, Inoue Y, Kauczor HU, Luo F, Mazzone PJ, Prokop M, Remy-Jardin M, Richeldi L, Schaefer-Prokop CM, Tomiyama N, Wells AU, Leung AN. The Role of Chest Imaging in Patient Management During the COVID-19 Pandemic: A Multinational Consensus Statement From the Fleischner Society. Chest. 2020 Jul;158(1):106-116. doi: 10.1016/j.chest.2020.04.003. Epub 2020 Apr 7.
PubMed 32275978Wynants L, Van Calster B, Collins GS, Riley RD, Heinze G, Schuit E, Bonten MMJ, Dahly DL, Damen JAA, Debray TPA, de Jong VMT, De Vos M, Dhiman P, Haller MC, Harhay MO, Henckaerts L, Heus P, Kammer M, Kreuzberger N, Lohmann A, Luijken K, Ma J, Martin GP, McLernon DJ, Andaur Navarro CL, Reitsma JB, Sergeant JC, Shi C, Skoetz N, Smits LJM, Snell KIE, Sperrin M, Spijker R, Steyerberg EW, Takada T, Tzoulaki I, van Kuijk SMJ, van Bussel B, van der Horst ICC, van Royen FS, Verbakel JY, Wallisch C, Wilkinson J, Wolff R, Hooft L, Moons KGM, van Smeden M. Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328.
PubMed 32265220Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015 Jan 6;162(1):55-63. doi: 10.7326/M14-0697.
PubMed 25560714
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Predictive Models for Intensive Care Admission and Death of COVID-19 Patients in a Secondary Care Hospital in Belgium.
- ClinicalTrials.gov ID
- NCT04401228
- Acronym / sponsor ID
- 0410508057
- Conditions
- COVID19, Pneumonia, Viral, Inflammatory Response
- Keywords
- COVID19, prediction scores, ICU admission, death, TRIPOD.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinique Saint Pierre OttigniesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 26 May 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 build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines.
The outcomes of the study are (i) admission in the Intensive Care Unit admission and (ii) death.
All patients admitted in the Emergency Department with a positive reverse transcription-polymerase chain reaction SARS-COV2 test were included in the study. Routine clinical and laboratory data were collected at their admission and during their stay. Chest X-Rays and CT-Scans were performed and analyzed by a senior radiologist.
Generalized Linear Models using a binomial distribution with a logit link function (R software version X) were used to develop predictive scores for (i) admission to ICU among emergency ward patients; (ii) death among ICU patients. A first panel of Number Models with the highest AIC (BIC) was preselected. Ten-fold cross-validation was then used to estimate the out-of-sample prediction error among these preselected models. The one with the smallest prediction error was in the end singled out .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covid ICU patients | – | Other: predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? |
| covid conventionnal ward | – | Other: predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patient with COVID 19 with viral pneumonia
Key inclusion criteria (1 listed)
- RT-PCR + SARS Cov2 pneumonia
Key exclusion criteria (1 listed)
- < 18 ans -* GOLD 3 or 4 CPOD
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 |
|---|---|---|
| predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?patients were questioned about their usual medication (Sartan, angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory drug, immunosuppressive drugs), their health condition (diabetes, hypertension, tobacco use, mental status). The Body mass index was computed. Age, gender, caucasian/african, weight, body mass index, number of days with symptoms before hospitalization, asthenia, pyrexia, dyspnea, chest pain, digestive sign, anosmia, ageusia, confusion, Travel or contact < one month, cigarette consumption ,hypertension, diabetes, mental status, angiotensin-converting-enzyme inhibitors, Sartan, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, SpO2,Thoracic Computerized Tomography : % of lung injury, Thoracic Computerized Tomography : density of lung injury, blood type, white blood cells, neutrophils, lymphocytes, blood platelets, fibrinogen, ferritin, triglycerides, LDH, troponin, CRP. The dates of admission to ICU and death were recorded | Other | covid ICU patients, covid conventionnal ward |
Primary outcome
admission to ICU
Time frame: through study completion, an average of 1 year
1 secondary outcome
death
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 26 May 2020.
- Background: PubMed 32275978Rubin GD, Ryerson CJ, Haramati LB, Sverzellati N, Kanne JP, Raoof S, Schluger NW, Volpi A, Yim JJ, Martin IBK, Anderson DJ, Kong C, Altes T, Bush A, Desai SR, Goldin J, Goo JM, Humbert M, Inoue Y, Kauczor HU, Luo F, Mazzone PJ, Prokop M, Remy-Jardin M, Richeldi L, Schaefer-Prokop CM, Tomiyama N, Wells AU, Leung AN. The Role of Chest Imaging in Patient Management During the COVID-19 Pandemic: A Multinational Consensus Statement From the Fleischner Society. Chest. 2020 Jul;158(1):106-116. doi: 10.1016/j.chest.2020.04.003. Epub 2020 Apr 7.
- Background: PubMed 32265220Wynants L, Van Calster B, Collins GS, Riley RD, Heinze G, Schuit E, Bonten MMJ, Dahly DL, Damen JAA, Debray TPA, de Jong VMT, De Vos M, Dhiman P, Haller MC, Harhay MO, Henckaerts L, Heus P, Kammer M, Kreuzberger N, Lohmann A, Luijken K, Ma J, Martin GP, McLernon DJ, Andaur Navarro CL, Reitsma JB, Sergeant JC, Shi C, Skoetz N, Smits LJM, Snell KIE, Sperrin M, Spijker R, Steyerberg EW, Takada T, Tzoulaki I, van Kuijk SMJ, van Bussel B, van der Horst ICC, van Royen FS, Verbakel JY, Wallisch C, Wilkinson J, Wolff R, Hooft L, Moons KGM, van Smeden M. Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328.
- Background: PubMed 25560714Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015 Jan 6;162(1):55-63. doi: 10.7326/M14-0697.
- Individual participant dataSharing planned: Yes
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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 COVID19 and Pneumonia, Viral, run by Clinique Saint Pierre Ottignies at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 26 May 2020. 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 Belgium. 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?
admission to ICU (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401228, which also lists 3 linked publications.
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 26 May 2020.