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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.

3.
Respir Med ; 176: 106261, 2021 01.
Article in English | MEDLINE | ID: covidwho-943576

ABSTRACT

BACKGROUND: Asthma prevalence among COVID-19 patients seems to be surprisingly low. However the clinical profile of COVID-19 asthmatic patients and potential determinants of higher susceptibility/worse outcome have been scarcely investigated. We aimed to describe the prevalence and features of asthmatic patients hospitalized for COVID-19 and to explore the association between their clinical asthma profile and COVID-19 severity. METHODS: Medical records of patients admitted to COVID-Units of six Italian cities major hospitals were reviewed. Demographic and clinical data were analyzed and compared according to the COVID-19 outcome (death/need for ventilation vs discharge at home without requiring invasive procedures). RESULTS: Within the COVID-Units population (n = 2000) asthma prevalence was 2.1%. Among the asthmatics the mean age was 61.1 years and 60% were females. Around half of patients were atopic, blood eosinophilia was normal in most of patients. An asthma exacerbation in the 6 months before the Covid-Unit admittance was reported by 18% of patients. 24% suffered from GINA step 4-5 asthma, and 5% were under biologic treatment. 31% of patients were not on regular treatment and a negligible use of oral steroid was recorded. Within the worse outcome group, a prevalence of males was detected (64 vs 29%, p = 0.026); they suffered from more severe asthma (43 vs 14%, p = 0.040) and were more frequently current or former smokers (62 vs 25%, p = 0.038). CONCLUSIONS: Our report, the first including a large COVID-19 hospitalized Italian population, confirms the low prevalence of asthma. On the other side patients with GINA 4/5 asthma, and those not adequately treated, should be considered at higher risk.


Subject(s)
Asthma/epidemiology , COVID-19/complications , Adult , Aged , Asthma/therapy , Asthma/virology , COVID-19/diagnosis , COVID-19/therapy , Critical Care , Female , Hospitalization , Humans , Italy , Male , Middle Aged , Prevalence , Respiration, Artificial , Retrospective Studies , Severity of Illness Index
6.
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
7.
J Clin Invest ; 130(9): 4694-4703, 2020 09 01.
Article in English | MEDLINE | ID: covidwho-401302

ABSTRACT

BACKGROUNDCoronavirus disease 19 (COVID-19) is an emerging infectious disease caused by SARS-CoV-2. Antiviral immune response is crucial to achieve pathogen clearance; however, in some patients an excessive and aberrant host immune response can lead to an acute respiratory distress syndrome. The comprehension of the mechanisms that regulate pathogen elimination, immunity, and pathology is essential to better characterize disease progression and widen the spectrum of therapeutic options.METHODSWe performed a flow cytometric characterization of immune cell subsets from 30 patients with COVID-19 and correlated these data with clinical outcomes.RESULTSPatients with COVID-19 showed decreased numbers of circulating T, B, and NK cells and exhibited a skewing of CD8+ T cells toward a terminally differentiated/senescent phenotype. In agreement, CD4+ T and CD8+ T, but also NK cells, displayed reduced antiviral cytokine production capability. Moreover, a reduced cytotoxic potential was identified in patients with COVID-19, particularly in those who required intensive care. The latter group of patients also showed increased serum IL-6 levels that inversely correlated to the frequency of granzyme A-expressing NK cells. Off-label treatment with tocilizumab restored the cytotoxic potential of NK cells.CONCLUSIONThe association between IL-6 serum levels and the impairment of cytotoxic activity suggests the possibility that targeting this cytokine may restore antiviral mechanisms.FUNDINGThis study was supported by funds from the Department of Experimental and Clinical Medicine of University of Florence (the ex-60% fund and the "Excellence Departments 2018-2022 Project") derived from Ministero dell'Istruzione, dell'Università e della Ricerca (Italy).


Subject(s)
Betacoronavirus , Coronavirus Infections/immunology , Cytotoxicity, Immunologic , Interleukin-6/immunology , Pneumonia, Viral/immunology , Adult , Aged , Aged, 80 and over , B-Lymphocytes/immunology , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , COVID-19 , Coronavirus Infections/blood , Coronavirus Infections/epidemiology , Critical Care , Cytokines/blood , Cytokines/immunology , Female , Granzymes/blood , Granzymes/immunology , Humans , Interleukin-6/blood , Killer Cells, Natural/immunology , Male , Middle Aged , Models, Immunological , Pandemics , Pneumonia, Viral/blood , Pneumonia, Viral/epidemiology , SARS-CoV-2
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