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Predictors of Severe Respiratory Failure in Hospitalized Patients with SARS-CoV-2 Infection: Development and Validation of a Prediction Model (PREDI-CO Study)

30 Pages Posted: 3 Jun 2020

See all articles by Michele Bartoletti

Michele Bartoletti

University of Bologna - Infectious Diseases Unit

Maddalena Giannella

University of Bologna - Infectious Diseases Unit

Luigia Scudeller

IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano - Scientific Direction - Clinical Trials Team

Sara Tedeschi

University of Bologna - Infectious Diseases Unit

Matteo Rinaldi

University of Bologna - Infectious Diseases Unit

Linda Bussini

University of Bologna - Infectious Diseases Unit

Giacomo Fornaro

University of Bologna - Infectious Diseases Unit

Renato Pascale

University of Bologna - Infectious Diseases Unit

Livia Pancaldi

University of Bologna - Infectious Diseases Unit

Zeno Pasquini

Azienda Ospedaliera Ospedali Riuniti Marche Nord - Infectious Diseases Unit

Filippo Trapani

University of Bologna - Infectious Diseases Unit

Lorenzo Badia

University of Bologna - Infectious Diseases Unit

Caterina Campoli

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Infectious Disease Unit

Marina Tadolini

University of Bologna - Infectious Diseases Unit

Luciano Attard

University of Bologna - Infectious Diseases Unit

Massimo Puoti

Grande Ospedale Metropolitano Niguarda - Division of Infectious Diseases

Marco Merli

Grande Ospedale Metropolitano Niguarda - Division of Infectious Diseases

Cristina Mussini

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Marianna Menozzi

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Marianna Meschiari

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Mauro Codeluppi

Guglielmo da Saliceto Hospital - Infectious Diseases Unit

Francesco Barchiesi

Azienda Ospedaliera Ospedali Riuniti Marche Nord - Infectious Diseases Unit

Francesco Cristini

Rimini-Forlì-Cesena Hospitals - Infectious Diseases Unit

Annalisa Saracino

University of Bari - Department of Biomedical Sciences and Human Oncology- Infectious Disease Unit

Alberto Licci

August Murri Hospital - Infectious Disease Unit

Silvia Rapuano

GVM Care & Research - Maria Cecilia Hospital

Tommaso Tonetti

University of Bologna - Intensive Care Unit

Paolo Gaibani

Policlinico Sant'Orsola - 3Centro di riferimento regionale per le emergenze microbiologiche (CRREM)

Vito Marco Ranieri

University of Bologna - Intensive Care Unit

Pierluigi Viale

University of Bologna - Infectious Diseases Unit

More...

Abstract

Background: Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-associated coronavirus disease-2019 (COVID-19) is spreading worldwide challenging healthcare resources. To provide the best possible care for patients, efficient prognosis is needed.

Methods: We performed a multicentre cohort study to develop and validate a risk score for severe respiratory failure (SRF) among hospitalized patients diagnosed with COVID-19. Study population included all adult patients with RT-PCR on nasopharyngeal swab positive for SARS-CoV-2, hospitalized from February 22 to April 3 2020, at 11 hospitals from four Italian Regions. Exclusion criteria were early (<24 hours) hospital discharge or early (<24 hours) SRF from hospitalization. Patients were divided into derivation and validation cohorts according to random sorting of hospitals. Exposure variables were assessed at hospital admission and included: demographics, comorbidities, symptoms at onset and at hospitalization, vital signs and laboratory tests. SRF was assessed from admission to hospital discharge and was defined as: SpO2<93% with 100% FiO2, respiratory rate (RR) >30bpm, or respiratory distress.


Findings: Of the 1265 included patients, 1044 patients were analyzed, (581 derivation, 463 validation cohort). Mean age was 65.7±15 years, 661 (63·3%) were male. SRF rates were 29% and 38% in derivation and validation cohort, respectively. At multivariate analysis, risk factors for SRF in the derivation cohort were age ≥70 years, obesity, body temperature ≥38°C, RR ≥22bpm, lymphocytes ≤900/mm3, creatinine ≥ 1 mg/dl, C-reactive protein ≥10mg/dl, and lactate dehydrogenase ≥350IU/L at hospitalization. Area under receiver-operator curve (AUROC) was 0·90 (95%CI 0.86-0.93). Assigning points to each variable an individual risk score (PREDICO score) was obtained. At risk score of >3, sensitivity, specificity, positive and negative predictive values were 71·6% (64-78), 89·1% (85-92), 72·9% (65-79), and 88·4% (85-91), respectively; positive and negative likelihood ratios were 6·56 (95% CI 4·9-8·77) and 0·31 (95%CI 0·25-0·40), respectively. PREDICO score showed similar prognostic ability in the validation cohort: AUROC 0·80 (0·74-0·88).

Interpretation: Using eight variables, easy to obtain at hospitalization, patients with COVID-19 could be classified according to their probability of developing SRF during hospitalization. PREDICO score can be useful to allocate resources and prioritize treatments during COVID-19 pandemic.

Trial Registration: NCT04316949.

Funding Statement: None.

Declaration of Interests: Authors state no conflict of interest related to the content of the present study.

Ethics Approval Statement: The study was approved by the Ethic Committee of the promoting center (Comitato Etico Indipendente di Area Vasta Emilia Centro, n. 283/2020/Oss/AOUBo).

Suggested Citation

Bartoletti, Michele and Giannella, Maddalena and Scudeller, Luigia and Tedeschi, Sara and Rinaldi, Matteo and Bussini, Linda and Fornaro, Giacomo and Pascale, Renato and Pancaldi, Livia and Pasquini, Zeno and Trapani, Filippo and Badia, Lorenzo and Campoli, Caterina and Tadolini, Marina and Attard, Luciano and Puoti, Massimo and Merli, Marco and Mussini, Cristina and Menozzi, Marianna and Meschiari, Marianna and Codeluppi, Mauro and Barchiesi, Francesco and Cristini, Francesco and Saracino, Annalisa and Licci, Alberto and Rapuano, Silvia and Tonetti, Tommaso and Gaibani, Paolo and Ranieri, Vito Marco and Viale, Pierluigi, Predictors of Severe Respiratory Failure in Hospitalized Patients with SARS-CoV-2 Infection: Development and Validation of a Prediction Model (PREDI-CO Study) (4/25/2020). Available at SSRN: https://ssrn.com/abstract=3588558 or http://dx.doi.org/10.2139/ssrn.3588558

Michele Bartoletti

University of Bologna - Infectious Diseases Unit

Italy

Maddalena Giannella (Contact Author)

University of Bologna - Infectious Diseases Unit ( email )

Via Massarenti 11
Bologna, 40137
Italy
+390512143199 (Phone)
+39051343500 (Fax)

Luigia Scudeller

IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano - Scientific Direction - Clinical Trials Team

Milano
Italy

Sara Tedeschi

University of Bologna - Infectious Diseases Unit

Italy

Matteo Rinaldi

University of Bologna - Infectious Diseases Unit

Italy

Linda Bussini

University of Bologna - Infectious Diseases Unit

Italy

Giacomo Fornaro

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Renato Pascale

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Livia Pancaldi

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Zeno Pasquini

Azienda Ospedaliera Ospedali Riuniti Marche Nord - Infectious Diseases Unit

Pesaro
Italy

Filippo Trapani

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Lorenzo Badia

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Caterina Campoli

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Infectious Disease Unit ( email )

Bologna
Italy

Marina Tadolini

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Luciano Attard

University of Bologna - Infectious Diseases Unit

Via Massarenti 11
Bologna, 40137
Italy

Massimo Puoti

Grande Ospedale Metropolitano Niguarda - Division of Infectious Diseases

Milan
Italy

Marco Merli

Grande Ospedale Metropolitano Niguarda - Division of Infectious Diseases

Milan
Italy

Cristina Mussini

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Viale A. Allegri 9
Modena, Modena 42121
Italy

Marianna Menozzi

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Viale A. Allegri 9
Modena, Modena 42121
Italy

Marianna Meschiari

Università degli studi di Modena e Reggio Emilia (UNIMORE) - Infectious Diseases Unit

Viale A. Allegri 9
Modena, Modena 42121
Italy

Mauro Codeluppi

Guglielmo da Saliceto Hospital - Infectious Diseases Unit

Piacenza
Italy

Francesco Barchiesi

Azienda Ospedaliera Ospedali Riuniti Marche Nord - Infectious Diseases Unit

Pesaro
Italy

Francesco Cristini

Rimini-Forlì-Cesena Hospitals - Infectious Diseases Unit

Rimini
Italy

Annalisa Saracino

University of Bari - Department of Biomedical Sciences and Human Oncology- Infectious Disease Unit

Policlinico di Bari
Italy

Alberto Licci

August Murri Hospital - Infectious Disease Unit

Fermo
Italy

Silvia Rapuano

GVM Care & Research - Maria Cecilia Hospital

Italy

Tommaso Tonetti

University of Bologna - Intensive Care Unit

Italy

Paolo Gaibani

Policlinico Sant'Orsola - 3Centro di riferimento regionale per le emergenze microbiologiche (CRREM)

Bologna
Italy

Vito Marco Ranieri

University of Bologna - Intensive Care Unit

Italy

Pierluigi Viale

University of Bologna - Infectious Diseases Unit

Italy

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