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

NCT04401228 | Unknown DMC

• 1 other identifier: 0410508057
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

COVID19; Pneumonia, Viral; Inflammatory Response

Keywords

COVID19, prediction scores, ICU admission, death, TRIPOD.

Outcome Measures

Primary Outcomes (1)

• admission to ICU

  through study completion, an average of 1 year

Secondary Outcomes (1)

• death

  through study completion, an average of 1 year

Study Arms (2)

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?

Interventions

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

covid ICU patients; covid conventionnal ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patient with COVID 19 with viral pneumonia

You may qualify if:

• RT-PCR + SARS Cov2 pneumonia

You may not qualify if:

• \< 18 ans -\* GOLD 3 or 4 CPOD

Sponsors & Collaborators

• Clinique Saint Pierre Ottignies: lead

Study Sites (1)

Clinique Saint-Pierre

Ottignies, Brabant Wallon, 1340, Belgium

Location

Related Publications (3)

• 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.

  PMID: 32275978 BACKGROUND

• Wynants 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.

  PMID: 32265220 BACKGROUND

• 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.

  PMID: 25560714 BACKGROUND

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral; Death

Interventions

Death Domain; Biological Products

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Death Domain Superfamily; Protein Interaction Domains and Motifs; Protein Domains; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)