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1.
Panminerva Med ; 2022 Mar 11.
Article in English | MEDLINE | ID: covidwho-1743139

ABSTRACT

BACKGROUND: To assess the clinical effectiveness of Tocilizumab (TCZ) in moderate-to-severe hospitalized COVID-19 patients and factors associated with clinical response. METHODS: 508 inpatients with moderate-to-severe SARS-CoV-2 infection were enrolled. TCZ effect in addition to standard medical therapy was evaluated in terms of death during hospital stay. Unadjusted and adjusted risk of mortality for TCZ treated patients versus TCZ untreated ones was estimated using robust Cox regression model. We considered the combination of TCZ and ICU as time-dependent exposure and created a model using duplication method to assess the TCZ effect in very severe COVID-19 patients. RESULTS: TCZ REDUCED DEATH DURING HOSPITAL STAY IN THE UNADJUSTED MODEL (HR 0.54, 95%CI 0.33- 0.88) and also in the adjusted model, although with loss of statistical significance (HR 0.72, 0.43- 1.20). Better effectiveness was observed in patients with low SpO2/FiO2 ratio (HR 0.35, 0.21-0.61 vs 1.61, 0.54-4.82, p<0.05), and, without statistical significance, in patients with high CRP (HR 0.51, 0.30-0.87 vs 0.41, 0.12-1.37, p =NS) and high IL-6 (HR 0.49, 0.29-0.82 vs 1.00, 0.28-3.55, p=NS). TCZ was effective in patients not admitted to ICU, both in the unadjusted (HR 0.33, 0.14-0.74) and in the adjusted (HR 0.39, 0.17-0.91) model but no benefit was observed in critical ICU-admitted patients both in the unadjusted (HR 0.66, 0.37-1.15) and in the adjusted model (HR 0.95, 0.54-1.68). CONCLUSIONS: our real-life study suggests clinical efficacy of TCZ in moderate-to-severe COVID-19 patients but not in end-stage disease. Thus, to enhance TCZ effectiveness, patients should be selected before grave compromise of clinical conditions.

2.
Eur J Endocrinol ; 185(1): 137-144, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1477604

ABSTRACT

OBJECTIVE: Hyponatremia is the most common electrolyte disorder in hospitalized patients and occurs in about 30% of patients with pneumonia. Hyponatremia has been associated with a worse outcome in several pathologic conditions The main objective of this study was to determine whether serum sodium alterations may be independent predictors of the outcome of hospitalized COVID-19 patients. DESIGN AND METHODS: In this observational study, data from 441 laboratory-confirmed COVID-19 patients admitted to a University Hospital were collected. After excluding 61 patients (no serum sodium at admission available, saline solution infusion before sodium assessment, transfer from another hospital), data from 380 patients were analyzed. RESULTS: 274 (72.1%) patients had normonatremia at admission, 87 (22.9%) patients had hyponatremia and 19 (5%) patients had hypernatremia. We found an inverse correlation between serum sodium and IL-6, whereas a direct correlation between serum sodium and PaO2/FiO2 ratio was observed. Patients with hyponatremia had a higher prevalence of non-invasive ventilation and ICU transfer than those with normonatremia or hypernatremia. Hyponatremia was an independent predictor of in-hospital mortality (2.7-fold increase vs normonatremia) and each mEq/L of serum sodium reduction was associated with a 14.4% increased risk of death. CONCLUSIONS: These results suggest that serum sodium at admission may be considered as an early prognostic marker of disease severity in hospitalized COVID-19 patients.


Subject(s)
COVID-19/blood , SARS-CoV-2 , Severity of Illness Index , Sodium/blood , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/mortality , Comorbidity , Critical Care/statistics & numerical data , Female , Fluorocarbons/blood , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Hydrocarbons, Brominated/blood , Hypernatremia/epidemiology , Hyponatremia/epidemiology , Interleukin-6/blood , Male , Middle Aged , Respiration, Artificial/statistics & numerical data , Retrospective Studies , SARS Virus
3.
Postgrad Med ; 134(1): 58-63, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1454909

ABSTRACT

BACKGROUND: In COVID-19 patients the progressive clinical deterioration seems secondary to the activation of a cytokine storm. Ferritin is considered a direct mediator of the immune system and some evidences suggested a shared physio-pathogenic basis between COVID-19 and 'Hyperferritinemic Syndromes.' The aim of our study was to evaluate the prognostic role of ferritin in COVID-19 patients. METHODS: We retrospectively studied consecutive COVID-19 patients admitted to four Italian Internal Medicine Units. Role of potential prognostic markers was evaluated with binary logistic regression analysis and results were expressed as odds ratios (ORs) with the corresponding 95% confidence intervals (CIs). Poor outcome was defined as death or need to transfer in the intensive care unit. RESULTS: Two hundred patients were included (mean age 68.75 ± 13.22 years). Ferritin value was highly elevated (>3000 ng/mL) in 8% of our population; 13% of patients were transferred to intensive care units and 12% of patients died. At multivariate analysis, highly elevated ferritin levels (OR 16.67 C.I. 4.89-57.57 p < 0.001) and hemoglobin < 10 g/dL (OR 8.88 C.I. 2.02-39.09 p = 0.004) were independently associated with a bad outcome.Patients with ferritin values > 3000 ng/ml appeared to have an inflammatory activation with elevated values of CRP and D-dimer and low values of lymphocyte count. CONCLUSION: Our results confirm the prognostic role of ferritin in hospitalized COVID-19 patients. Patients with high ferritin levels should be considered critically ill and treated in an adequate setting. Furthermore, COVID-19 seems to share some characteristics with hyperferritinemic syndromes with potential therapeutic implications.


Subject(s)
COVID-19 , Aged , Aged, 80 and over , Ferritins , Humans , Middle Aged , Prognosis , Retrospective Studies , SARS-CoV-2
4.
Int J Infect Dis ; 108: 231-236, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1202384

ABSTRACT

OBJECTIVE: Evaluate the real-world accuracy of Myxovirus resistance protein A (MxA) detected by the rapid, point-of-care FebriDx test during the second-wave pandemic in Italy in patients with acute respiratory infection (ARI) and a clinical suspicion of COVID-19. DESIGN AND METHODS: Prospective, observational, diagnostic accuracy study whereby hospitalized patients with ARI were consecutively enrolled in a single tertiary care center in Italy from August 1, 2020 to January 31, 2021. RESULTS: COVID-19 was diagnosed in 136/200 (68.0%) patients and Non-COVID-19 was diagnosed in 64/200 (32.0%) patients. COVID-19 patients were younger and had a lower Charlson comorbidity index compared to Non-COVID-19 patients (p < 0.001). Concordance between FebriDx, MxA and rt-PCR for SARS-CoV-2 (gold standard) was good (k 0.93, 95% CI 0.87-0.99). Overall sensitivity and specificity were 97.8% [95% CI 93.7-99.5] and 95.3% [95% CI 86.9%-99.0%], respectively. FebriDx demonstrated a negative predictive value of 95.3% (95% CI 86.9-99.0) for an observed disease prevalence of 68%. CONCLUSIONS: FebriDx MxA showed high diagnostic accuracy to identify COVID-19 and could be considered as a real-time triage tool to streamline the management of suspected COVID-19 patients. FebriDx also detected bacterial etiology in Non-COVID-19 patients suggesting good performance to distinguish bacterial from viral respiratory infection.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19 Testing , Humans , Italy/epidemiology , Point-of-Care Testing , Prospective Studies , Sensitivity and Specificity
6.
BMJ Open ; 10(9): e040729, 2020 09 25.
Article in English | MEDLINE | ID: covidwho-797443

ABSTRACT

OBJECTIVES: Several physiological abnormalities that develop during COVID-19 are associated with increased mortality. In the present study, we aimed to develop a clinical risk score to predict the in-hospital mortality in COVID-19 patients, based on a set of variables available soon after the hospitalisation triage. SETTING: Retrospective cohort study of 516 patients consecutively admitted for COVID-19 to two Italian tertiary hospitals located in Northern and Central Italy were collected from 22 February 2020 (date of first admission) to 10 April 2020. PARTICIPANTS: Consecutive patients≥18 years admitted for COVID-19. MAIN OUTCOME MEASURES: Simple clinical and laboratory findings readily available after triage were compared by patients' survival status ('dead' vs 'alive'), with the objective of identifying baseline variables associated with mortality. These were used to build a COVID-19 in-hospital mortality risk score (COVID-19MRS). RESULTS: Mean age was 67±13 years (mean±SD), and 66.9% were male. Using Cox regression analysis, tertiles of increasing age (≥75, upper vs <62 years, lower: HR 7.92; p<0.001) and number of chronic diseases (≥4 vs 0-1: HR 2.09; p=0.007), respiratory rate (HR 1.04 per unit increase; p=0.001), PaO2/FiO2 (HR 0.995 per unit increase; p<0.001), serum creatinine (HR 1.34 per unit increase; p<0.001) and platelet count (HR 0.995 per unit increase; p=0.001) were predictors of mortality. All six predictors were used to build the COVID-19MRS (Area Under the Curve 0.90, 95% CI 0.87 to 0.93), which proved to be highly accurate in stratifying patients at low, intermediate and high risk of in-hospital death (p<0.001). CONCLUSIONS: The COVID-19MRS is a rapid, operator-independent and inexpensive clinical tool that objectively predicts mortality in patients with COVID-19. The score could be helpful from triage to guide earlier assignment of COVID-19 patients to the most appropriate level of care.


Subject(s)
Betacoronavirus/isolation & purification , Coronavirus Infections , Critical Care , Critical Pathways , Pandemics , Pneumonia, Viral , Risk Assessment/methods , Triage , Aged , COVID-19 , Coronavirus Infections/blood , Coronavirus Infections/diagnosis , Coronavirus Infections/mortality , Coronavirus Infections/physiopathology , Critical Care/methods , Critical Care/statistics & numerical data , Critical Pathways/organization & administration , Critical Pathways/standards , Female , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Italy/epidemiology , Male , Middle Aged , Pneumonia, Viral/blood , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Pneumonia, Viral/physiopathology , Prognosis , Respiration, Artificial/statistics & numerical data , Retrospective Studies , SARS-CoV-2 , Triage/methods , Triage/statistics & numerical data
7.
Immunology ; 161(4): 345-353, 2020 12.
Article in English | MEDLINE | ID: covidwho-738708

ABSTRACT

SARS-CoV-2 is responsible for a new infectious disease (COVID-19) in which individuals can either remain asymptomatic or progress from mild to severe clinical conditions including acute respiratory distress syndrome and multiple organ failure. The immune mechanisms that potentially orchestrate the pathology in SARS-CoV-2 infection are complex and only partially understood. There is still paucity of data on the features of myeloid cells involved in this viral infection. For this reason, we investigated the different activation status profiles and the subset distribution of myeloid cells and their correlation with disease progression in 40 COVID-19 patients at different stages of disease. COVID-19 patients showed a decrease in the absolute number of plasmacytoid and myeloid dendritic cells, different subset distribution of monocytes and different activation patterns of both monocytes and neutrophils, coupled to a significant reduction of HLA-DR monocyte levels. We found that some of these alterations are typical of all COVID-19 patients, while some others vary at different stages of the disease and correlate with biochemical parameters of inflammation. Collectively, these data suggest that not only the lymphoid, but also the myeloid compartment, is severely affected by SARS-CoV-2 infection.


Subject(s)
COVID-19/immunology , Dendritic Cells/immunology , Myeloid Cells/immunology , Adult , Aged , COVID-19/pathology , Dendritic Cells/pathology , Female , Flow Cytometry , Humans , Intensive Care Units , Male , Myeloid Cells/pathology
8.
Leukemia ; 35(4): 1121-1133, 2021 04.
Article in English | MEDLINE | ID: covidwho-725732

ABSTRACT

Overwhelming inflammatory reactions contribute to respiratory distress in patients with COVID-19. Ruxolitinib is a JAK1/JAK2 inhibitor with potent anti-inflammatory properties. We report on a prospective, observational study in 34 patients with COVID-19 who received ruxolitinib on a compassionate-use protocol. Patients had severe pulmonary disease defined by pulmonary infiltrates on imaging and an oxygen saturation ≤ 93% in air and/or PaO2/FiO2 ratio ≤ 300 mmHg. Median age was 80.5 years, and 85.3% had ≥ 2 comorbidities. Median exposure time to ruxolitinib was 13 days, median dose intensity was 20 mg/day. Overall survival by day 28 was 94.1%. Cumulative incidence of clinical improvement of ≥2 points in the ordinal scale was 82.4% (95% confidence interval, 71-93). Clinical improvement was not affected by low-flow versus high-flow oxygen support but was less frequent in patients with PaO2/FiO2 < 200 mmHg. The most frequent adverse events were anemia, urinary tract infections, and thrombocytopenia. Improvement of inflammatory cytokine profile and activated lymphocyte subsets was observed at day 14. In this prospective cohort of aged and high-risk comorbidity patients with severe COVID-19, compassionate-use ruxolitinib was safe and was associated with improvement of pulmonary function and discharge home in 85.3%. Controlled clinical trials are necessary to establish efficacy of ruxolitinib in COVID-19.


Subject(s)
COVID-19/drug therapy , COVID-19/virology , Compassionate Use Trials , Janus Kinase 1/antagonists & inhibitors , Janus Kinase 2/antagonists & inhibitors , Janus Kinase Inhibitors/therapeutic use , SARS-CoV-2/drug effects , Aged , Aged, 80 and over , Biomarkers , COVID-19/diagnosis , COVID-19/metabolism , Combined Modality Therapy , Comorbidity , Female , Humans , Janus Kinase Inhibitors/pharmacology , Male , Middle Aged , Nitriles , Prospective Studies , Pyrazoles/pharmacology , Pyrazoles/therapeutic use , Pyrimidines , Severity of Illness Index , Treatment Outcome , Viral Load
9.
J Allergy Clin Immunol Pract ; 8(8): 2575-2581.e2, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-611996

ABSTRACT

BACKGROUND: The early identification of patients at risk of clinical deterioration is of interest considering the timeline of COVID-19 after the onset of symptoms. OBJECTIVE: The aim of our study was to evaluate the usefulness of testing serum IL-6 and other serological and clinical biomarkers, to predict a short-term negative clinical course of patients with noncritical COVID-19. METHODS: A total of 208 patients with noncritical COVID-19 pneumonia at admission were consecutively enrolled. Clinical and laboratory findings obtained on admission were analyzed by using survival analysis and stepwise logistic regression for variable selection. Three-day worsening as outcome in a logistic model to generate a prognostic score was used. RESULTS: Clinical worsening occurred in 63 patients (16 = died; 39 = transferred to intensive care unit; 8 worsening of respiratory failure). Forty-five of them worsened within 3 days after admission. The risk of clinical worsening was progressively enhanced along with increasing quartiles of IL-6 levels. Multivariate analysis showed that IL-6 (P = .005), C-reactive protein (CRP) (P = .003), and SaO2/FiO2 (P = .014) were the best predictors for clinical deterioration in the first 3 days after admission. The combined score yielded an area under the curve = 0.88 (95% confidence interval: 0.83-0.93). A nomogram predicting the probability of 3-day worsening was generated. The score also showed good performance for 7-day and 14- or 21-day worsening and in predicting death occurring during all the follow-up. CONCLUSIONS: Combining IL-6, CRP, and SaO2/FiO2 in a score may help clinicians to identify on admission those patients with COVID-19 who are at high risk for a further 3-day clinical deterioration.


Subject(s)
Clinical Deterioration , Coronavirus Infections/epidemiology , Coronavirus Infections/physiopathology , Interleukin-6/blood , Pneumonia, Viral/epidemiology , Pneumonia, Viral/physiopathology , Adult , Aged , Aged, 80 and over , Betacoronavirus , Biomarkers , C-Reactive Protein/analysis , COVID-19 , Comorbidity , Coronavirus Infections/blood , Coronavirus Infections/mortality , Female , Humans , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Oxygen/blood , Pandemics , Pneumonia, Viral/blood , Pneumonia, Viral/mortality , ROC Curve , Retrospective Studies , SARS-CoV-2 , Time Factors , Young Adult
12.
Euro Surveill ; 25(17)2020 04.
Article in English | MEDLINE | ID: covidwho-142724

ABSTRACT

We analysed the first 84 coronavirus disease (COVID-19) patients hospitalised in an infectious and tropical disease unit in Florence, Italy, over 30 days after the start of the COVID-19 outbreak in Italy. A 12% reduction in the rate of intensive care unit transfer was observed after the implementation of intensity care measures in the regular ward such as increasing the nurse/patient ratio, presence of critical care physicians and using high flow nasal cannulae oxygenation.


Subject(s)
Coronavirus Infections/mortality , Coronavirus Infections/therapy , Coronavirus , Intensive Care Units/organization & administration , Pandemics , Pneumonia, Viral/mortality , Pneumonia, Viral/therapy , Age Distribution , Aged , Betacoronavirus , COVID-19 , Cannula , Cohort Studies , Comorbidity , Contact Tracing , Coronavirus Infections/diagnosis , Critical Care , Disease Outbreaks , Female , Humans , Italy/epidemiology , Male , Middle Aged , Patient Transfer , Pneumonia, Viral/diagnosis , Respiratory Care Units , SARS-CoV-2 , Sex Distribution , Treatment Outcome
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