Predictive Models for Intensive Care Admission and Death of COVID-19

COVID19 Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04401228
• Other study ID #: 0410508057
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2020
• Source: Clinique Saint Pierre Ottignies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 1, 2021
• Est. primary completion date: May 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• RT-PCR + SARS Cov2 pneumonia

Exclusion Criteria:

• < 18 ans -* GOLD 3 or 4 CPOD

Related Conditions & MeSH terms

• COVID19
• Inflammatory Response
• Pneumonia
• Pneumonia, Viral

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Clinique Saint-Pierre	Ottignies	Brabant Wallon

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Pierre Ottignies

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Collins 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. Erratum in: Ann Intern Med. 2015 Apr 21;162(8):600. — View Citation

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 Apr 7. pii: S0012-3692(20)30673-5. doi: 10.1016/j.chest.2020.04.003. [Epub ahead of print] — View Citation

Wynants L, Van Calster B, Bonten MMJ, Collins GS, Debray TPA, De Vos M, Haller MC, Heinze G, Moons KGM, Riley RD, Schuit E, Smits LJM, Snell KIE, Steyerberg EW, Wallisch C, van Smeden M. Prediction models for diagnosis and prognosis of covid-19 infection: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	admission to ICU		through study completion, an average of 1 year
Secondary	death		through study completion, an average of 1 year