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      A simple score (Biovid-19) based on biological parameters predicts transfer to intensive care units and death in COVID-19 patients

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          Abstract

          Background The COVID-19 pandemic, due to SARS-CoV2 infection, was characterized in France by a first wave of patients in the spring of 2020, followed by the current second wave beginning in October 2020. The clinical spectrum of SARS-CoV2 infection is broad, ranging from asymptomatic disease to severe pneumonia with respiratory failure, leading to intensive care unit (ICU) requirement in 14 % of the cases and to an overall estimated death rate around 2 % [1]. Some studies focused on mortality risk factors in patients with COVID-19 and identified age, comorbidities and biological parameters [2]. The relevance of common biological parameters is still to determine, and a scoring system relying on biological features at admittance to predict disease evolution would be highly useful. We present here the result of a monocentric study based on two cohorts, each corresponding to the epidemic waves of spring and fall/winter respectively. The first retrospective cohort of 154 patients, admitted in conventional or intensive care units, identified 3 biological relevant risk factors of increased mortality among the 36 analyzed: plasmatic sodium, potassium levels, and prothrombin time. This score was then prospectively validated in an independent cohort of 81 patients, showing a strong reliability to identify patients at risk of severe COVID-19 evolution. This biological score, relying on broadly available parameters, is an easy and usable tool to early discriminate high-risk patients that are most likely to benefit from intensive care treatment. Material and methods Study design and clinical features The first retrospective derivation cohort included all consecutive adult patients (≥ 18 years old) admitted from February 21 st, 2020 to March 30th, 2020 in University Hospital (CHU) of Amiens and diagnosed with COVID-19 according to the viral detection of SARS-CoV2 (PCR). The second prospective validation cohort included all consecutive adult patients admitted from October 19th, 2020 to November 17th, 2020 in the same hospital and diagnosed with COVID-19 with a similar test. Clinical and biological data were extracted from electronic medical records. The analyzed biological parameters were collected at hospital admittance (day 0). This study was approved by the institutional review board of Amiens University Hospital (number PI2020_843_0031, 30th March), and are in accordance with French legislation of non-interventional studies. Statistical analysis Student's t-test, receiver operating characteristic (ROC) curve analysis and Kaplan-Meier analysis were used as indicated. Univariate and multivariate analyses were performed using a step-by-step backward Cox regression. P < 0.05 was considered as statistically significant. Results Patient demographics and baseline characteristics In the derivation cohort, 154 patients were admitted with confirmed SARS-CoV2 infection in the Amiens hospital. These patients were hospitalized in conventional units (n = 111, 72 %) or ICU (n = 43, 28 %), and 18 of them were transferred from conventional to ICU. The median age at admission was 77 years (range 23–100), 56 % of the patients were male and 44 % female. The median length of stay was 12 days both in conventional care units and ICU. At the time of analysis, 122 patients were alive (79 %) and 32 died (21 %) from SARS-CoV2 infection. The second validation cohort prospectively included 81 SARS-CoV2 patients meeting the same criteria, whose characteristics were not statistically different from the first cohort (data not shown). Biological markers to identify high risk patients We then performed survival analyses to determine if biological parameters at diagnosis could predict clinical outcomes. OS was defined as time to death or latest news. To consider the risk of severe clinical worsening, EFS was defined as time to ICU transfer, death in conventional care units, or latest news. At median follow up, EFS and OS were close to 85 %. Univariate analysis for EFS identified lymphopenia (p = 0.048), hyponatremia (p = 0.003), high uremia levels (p = 0.02) and hypocalcemia (p = 0.01) as risk factors for severe clinical worsening, whereas age had no significant impact (p = 0.53). In multivariate analysis, hyponatremia (HR = 11.7 (95 %CI:3.1–44.2), p < 0.001) and low bicarbonate levels (HR = 5.4 (95 %CI:1.4–21), p = 0.02) negatively affected EFS. Regarding OS, hyponatremia (p = 0.038), hyperkaliemia (p = 0.005), high creatinine levels (p = 0.049), hyperphosphoremia (p = 0.006), and low O2 saturation (p = 0.01) significantly predicted shorter survival in univariate analysis. There was a trend for prolonged prothrombin time > 16,8 s (p = 0.1). Age was also an adverse prognostic factor for OS (p = 0.008, HR = 1.04 (1.01–1.07)). Then, in multivariate analysis, age (HR = 1.13 (95 %CI:1.04-1.22), p = 0.002), prothrombin time > 16,8 s (HR = 4.62 (95 %CI:1.19-17.94), p = 0.03), hyponatremia (HR = 6.99 (95 %CI:1.83-26.72), p = 0.005), and hyperkaliemia (HR = 12.1 (1.66–87.75), p = 0.01) were independent factors predicting shorter OS. Easy usable score to predict early survival in COVID-19 patients: Biovid-19 Based on the results of the multivariate analysis presented above, we proposed a simple biological prognostic score including sodium, potassium levels and prothrombin time. 0, 1 or 2 points are assigned to each of the 3 parameters, according to the weight of their respective HR, resulting in a score ranging from 0 to 6 (Table 1 ). Using ROC analysis, we proposed that a threshold ≥2 predicted poor prognosis with a sensitivity of 80,7 % and a specificity of 93,3 %. Therefore, we independently validated in our second prospective cohort an improved OS with a score <2 (Fig. 1 A), showing a strong reliability of Biovid-19 score to predict the risk of death in time-different waves. Interestingly, we also validated that Biovid-19 score predicts clinical worsening, as it prospectively highlighted a significantly lower cumulative incidence of both secondary transfer to ICU and development of Acute Respiratory Distress Syndrome (ARDS) in patients with a score <2 (Fig. 1B and C). Moreover, our score was significantly lower in non-hospitalized patients and patients hospitalized in conventional units compared to patients hospitalized in ICU (Fig. 1D), reflecting the association with severe disease presentation. Table 1 Biovid-19 score. Table 1 Parameter Range Score point Sodium (mmol/L) ≤130 2 ]130-135] 1 >135 0 Potassium (mmol/L) ≥5,5 2 ]5,5-5] 1 <5 0 PT (s) >20 2 ]20-16,8] 1 ≤16,8 0 Interpretation of the proposal score: Patient at high risk of mortality if score ≥2. Fig. 1 Overall survival according to the proposal score by the Kaplan Meier method. Fig. 1 Taken together, these data suggest that few common and broadly available biological parameters at admittance can easily and reliably identify patients at risk of severe Covid-19 evolution. We assume that the Biovid-19 prognostic score is useful to early identify high-risk patients requiring close monitoring, and could help guidance for early ICU admittance. Declarations Ethics approval and consent to participate : This study was approved by the institutional review board of Amiens University Hospital (number PI2020_843_0031, 30th March). Consent for publication Not applicable. Availability of data and materials Not applicable. Funding Not applicable. Authors’contribution TB and CS designed the research study. TB, CS, GC, ML, OE and AC collected and analysed the data. CF, EB and SC set up the virological diagnosis. RN, JLS, CA, JM managed patients and provided clinical data. TB, CS, GC, ML, AC and LG wrote the paper, which was approved by all the authors. Declaration of Competing Interest The authors declare that they have no competing interests.

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          Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

          Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p<0·0001), and d-dimer greater than 1 μg/mL (18·42, 2·64–128·55; p=0·0033) on admission. Median duration of viral shedding was 20·0 days (IQR 17·0–24·0) in survivors, but SARS-CoV-2 was detectable until death in non-survivors. The longest observed duration of viral shedding in survivors was 37 days. Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.
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            Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

            In December 2019, novel coronavirus (2019-nCoV)-infected pneumonia (NCIP) occurred in Wuhan, China. The number of cases has increased rapidly but information on the clinical characteristics of affected patients is limited.
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              Author and article information

              Journal
              Curr Res Transl Med
              Curr Res Transl Med
              Current Research in Translational Medicine
              Elsevier Masson SAS.
              2452-3186
              4 March 2021
              April 2021
              4 March 2021
              : 69
              : 2
              : 103284
              Affiliations
              [a ]CHU Amiens-Picardie, laboratoire de Biochimie, Amiens, France
              [b ]Equipe CHIMERE, EA 7516, Université de Picardie Jules Verne, Amiens, France
              [0015]CHU Amiens-Picardie, service d’Hématologie Biologique, Amiens, France
              [0020]CHU Amiens-Picardie, Médecine Intensive Et Réanimation, Amiens, France
              [0025]CHU Amiens-Picardie, service de Pathologie Infectieuse, Amiens, France
              [0030]CHU Amiens-Picardie, service de Pneumologie, Amiens, France
              [a ]CHU Amiens-Picardie, laboratoire de Virologie, Amiens, France
              [b ]Equipe AGIR, Université de Picardie Jules Verne, Amiens, France
              [0045]CHU Amiens-Picardie, Médecine Intensive et Réanimation, Amiens, France
              [a ]CHU Amiens-Picardie, service d’Hématologie Biologique, Amiens, France
              [b ]Equipe HEMATIM, EA 4666, Université de Picardie Jules Verne, France
              [a ]CHU Amiens-Picardie, laboratoire de Virologie, Amiens, France
              [b ]Equipe AGIR, Université de Picardie Jules Verne, Amiens, France
              [a ]CHU Amiens-Picardie, service d’Hématologie Clinique et de Thérapie Cellulaire, Amiens, France
              [b ]Equipe HEMATIM, EA 4666, Université de Picardie Jules Verne, France
              [a ]CHU Amiens-Picardie, service d’Hématologie Biologique, Amiens, France
              [b ]Equipe HEMATIM, EA 4666, Université de Picardie Jules Verne, France
              Author notes
              [* ]Corresponding author at: Service d’Hématologie Biologique, Centre de Biologie Humaine, 1 rond point du Pr Christian, Cabrol CHU Amiens-Picardie, 80054, Amiens cedex 1, France.
              Article
              S2452-3186(21)00010-6 103284
              10.1016/j.retram.2021.103284
              7931720
              85e8487d-8daa-4caf-8174-29caecc31c84
              © 2021 Elsevier Masson SAS. All rights reserved.

              Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

              History
              : 8 February 2021
              Categories
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