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1.
Viruses ; 15(5)2023 05 19.
Article in English | MEDLINE | ID: covidwho-20233031

ABSTRACT

INTRODUCTION: Remdesivir (REM) and monoclonal antibodies (mAbs) could alleviate severe COVID-19 in at-risk outpatients. However, data on their use in hospitalized patients, particularly in elderly or immunocompromised hosts, are lacking. METHODS: All consecutive patients hospitalized with COVID-19 at our unit from 1 July 2021 to 15 March 2022 were retrospectively enrolled. The primary outcome was the progression to severe COVID-19 (P/F < 200). Descriptive statistics, a Cox univariate-multivariate model, and an inverse probability treatment-weighted (IPTW) analysis were performed. RESULTS: Overall, 331 subjects were included; their median (q1-q3) age was 71 (51-80) years, and they were males in 52% of the cases. Of them, 78 (23%) developed severe COVID-19. All-cause in-hospital mortality was 14%; it was higher in those with disease progression (36% vs. 7%, p < 0.001). REM and mAbs resulted in a 7% (95%CI = 3-11%) and 14% (95%CI = 3-25%) reduction in the risk of severe COVID-19, respectively, after adjusting the analysis with the IPTW. In addition, by evaluating only immunocompromised hosts, the combination of REM and mAbs was associated with a significantly lower incidence of severe COVID-19 (aHR = 0.06, 95%CI = 0.02-0.77) when compared with monotherapy. CONCLUSIONS: REM and mAbs may reduce the risk of COVID-19 progression in hospitalized patients. Importantly, in immunocompromised hosts, the combination of mAbs and REM may be beneficial.


Subject(s)
COVID-19 , Aged , Male , Humans , Aged, 80 and over , Female , Retrospective Studies , COVID-19 Drug Treatment , Antibodies, Monoclonal/therapeutic use , Antibodies, Neutralizing , Immunocompromised Host , Disease Progression
2.
Sci Rep ; 13(1): 9035, 2023 06 03.
Article in English | MEDLINE | ID: covidwho-20244246

ABSTRACT

In respiratory infections, anemia is both a consequence of acute inflammation and a predictor of poor clinical outcomes. There are few studies investigating the role of anemia in COVID-19, suggesting a potential role in predicting disease severity. In this study, we aimed to assess the association between the presence of anemia at admission and incidence of severe disease and death in patients hospitalized for COVID-19. Data from all adult patients admitted for COVID-19 in University Hospital "P. Giaccone" Palermo, and University Hospital of Bari, Italy, were retrospectively collected from 1st of September 2020 to 31 August 2022. The association between anemia (defined as Hb < 13 g/dl and < 12 g/dl in males and females, respectively), in-hospital mortality and severe COVID-19 was tested using a Cox's regression analysis. Severe COVID-19 forms were defined as admission to intensive or sub-intensive care unit or a qSOFAscore ≥ 2 or CURB65scores ≥ 3. p values were calculated using the Student's t test for continuous variables and the Mantel-Haenszel Chi-square test for categorical ones. The association between anemia and the mortality was made using a Cox's regression analysis, adjusted, in two models, for the potential confounders and using a propensity score. Among the 1562 patients included in the analysis, prevalence of anemia was 45.1% (95% CI 43-48%). Patients with anemia were significantly older (p < 0.0001), reported more co-morbidities, and presented higher baseline levels of procalcitonin, CRP, ferritin and IL-6. Overall, the crude incidence of mortality was about four times higher in patients with anemia compared to those without. After adjusting for 17 potential confounders, the presence of anemia significantly increased the risk of death (HR = 2.68; 95% CI: 1.59-4.52) and of risk of severe COVID-19 (OR = 2.31; 95% CI: 1.65-3.24). The propensity score analysis substantially confirmed these analyses. Our study provides evidence that, in patients hospitalized for COVID-19, anemia is both associated with a more pronounced baseline pro-inflammatory profile and higher incidence of in-hospital mortality and severe disease.


Subject(s)
Anemia , COVID-19 , Male , Adult , Female , Humans , COVID-19/complications , Retrospective Studies , Anemia/epidemiology , Risk Factors , Disease Progression
3.
Pathog Glob Health ; 117(5): 513-519, 2023 07.
Article in English | MEDLINE | ID: covidwho-2269913

ABSTRACT

Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.


Subject(s)
COVID-19 , Pregnancy , Infant, Newborn , Humans , Female , SARS-CoV-2 , Pregnant Women , Antibodies, Monoclonal , Disease Progression
4.
J Cardiovasc Dev Dis ; 10(2)2023 Jan 31.
Article in English | MEDLINE | ID: covidwho-2225346

ABSTRACT

COVID-19 has threatened the capability of receiving and allocating patients in emergency departments (EDs) all over the world. This is a retrospective cohort study to explore the role of a simple procedure like an ECG to screen for the severity of COVID-19 on admission to the ED. For this study, 548 consecutive patients were enrolled in a multicenter international registry and stratified upon ECG on admission with a simple distinction between normal vs. abnormal rhythm. Among patients in the abnormal ECG group were those with heart rates higher than 100 beats per minute and/or atrial fibrillation. Survival in patients with normal ECG rhythm was deemed below 75% after 58 days and then stabilized, while survival in patients with abnormal ECG rhythm was deemed below 75% after 11 days and below 50% after 21 days. A multivariate analysis including abnormal rhythm, gender, age, diabetes, obesity, respiratory failure during hospitalization, heart failure during hospitalization, and abnormal rhythm was an independent predictor of death (HR 7.20 95% CI 3.63-14.28, p < 0.01). This finding, if confirmed in large prospective studies, is promising for identifying a cheap and simple procedure for patients in need of a closer look.

5.
Antibiotics (Basel) ; 11(11)2022 Oct 31.
Article in English | MEDLINE | ID: covidwho-2089985

ABSTRACT

Secondary bloodstream infections (BSIs) caused by KPC- and NDM-producing Klebsiella pneumoniae (K.p.) during the course of COVID-19 infections lead to significant mortality. Herein, a comparative retrospective case series of KPC- or NDM-K.p. BSIs occurring in COVID-19 subjects treated with Ceftazidime/Avibactam (CAZ/AVI) for KPC-K.p., or CAZ/AVI+ Aztreonam (ATM) for NDM-K.p is reported. All patients hospitalized for COVID-19 in two Italian hospitals with a BSI between March and September 2021 were included. The main outcome was 14-day mortality. Overall, 44 patients were included: 23 with KPC-K.p. and 21 with NDM-K.p. BSIs. The median (q1-q3) age was 67 (57-75) years, and 32 (72%) were males. The two groups were similar in terms of baseline comorbidity, or severity of COVID-19. Notably, 14-day mortality of KPC-K.p. BSIs and NDM-K.p. BSIs (26% vs. 38%, p = 0.521) and 28-day mortality (35% vs. 48%, p = 0.541) were similar. A Cox regression model of delayed initiation of an appropriate antibiotic therapy after the onset of symptoms independently predicted mortality: initiation between 24 and 72 h (aHR = 12.03; 95% CI = 1.10-130, p = 0.041); and initiation after 72h (aHR = 36.9, 95% CI = 3.22-424, p = 0.004). Moreover, a trend towards an increased risk of mortality was observed for polymicrobial infections (aHR = 3.73, 95% CI = 0.87-15.8, p = 0.074), while a protective effect was observed for a beta-lactam loading dose at the start of treatment (aHR = 0.16, 95% CI = 0.02-1.10, p = 0.064). The high mortality of KPC and NDM-K.p. BSIs in COVID-19 patients may be reduced by an early and appropriate antibiotic therapy. Further efforts should be made to develop antimicrobial stewardship and infection control programs in COVID-19 wards.

6.
Ann Glob Health ; 88(1): 26, 2022.
Article in English | MEDLINE | ID: covidwho-1847566

ABSTRACT

Background: The COVID-19 pandemic has undone years of progress in providing essential TB services and controlling the TB burden. Italy, a low TB burden country, has an incidence of 7.1 cases per 100,000 people. To control the TB spreading in Italy is critical to investigate the characteristics of patients with the worst outcomes and the highest risk of adverse events related to antituberculosis therapy. Therefore, we conducted a large retrospective study in TB patients admitted to the Clinic of Infectious Diseases University of Bari, Italy, in order to describe the clinical presentation and the factors associated with adverse events and outcomes. Methods: We retrospectively evaluated the patients admitted to the Clinic of Infectious Diseases from January 2013 to 15 December 2021. We stratified our cohort into two groups: <65 years of age and ≥65 years in order to assess any differences between the two groups. Two logistic regression models were implemented considering the dependent variables as: (I) the adverse events; and (II) the unsuccessful treatments. Results: In total, 206 consecutive patients [60% (n = 124) M, median age 39 years, range 16-92] were diagnosed and admitted with TB at Clinic of Infectious Diseases. Of the whole sample, 151 (74%) were <65 years and 55 (26%) were ≥65. Statistically significant differences between the two groups were detected (p-value < 0.05) for nationality (p-value = 0.01), previous contact with TB patient (p-value = 0.00), type of TB (p-value = 0.00), unsuccessful treatment (p-value = 0.00), length of hospitalization (p-value = 0.02) and diagnostic delay (p-value = 0.01). Adverse events related to TB drug regimen were reported in 24% (n = 49). Age < 65 years (O.R. = 3.91; 95% CI 1.72-4.21), non-Italian nationality (O.R. = 4.45; 95% CI 2.22-4.98.), homeless (O.R. = 3.23; 95% CI 2.58-4.54), presence of respiratory symptoms (O.R. = 1.23; 95% CI 1.10-1.90), diagnostic delay (O.R = 2.55; 95% CI 1.98-3.77) resulted associated with unsuccessful treatment outcome (death, failure or lost to follow up). Finally, age < 65 years (O.R. = 1.73; 95% CI 1.31-2.49), presence of pulmonary TB (O.R. = 1.15; 95% CI 1.02-1.35), length of hospitalization (O.R. = 1.82; 95% CI 1.35-2.57) and TB culture positive (O.R. = 1.35; 95% CI 1.12-1.82) were associated with adverse events in our populations. Conclusions: The pharmacological approach alone seems insufficient to treat and cure a disease whose ethiopathogenesis is not only due to the Mycobacterium tuberculosis, but also to the poverty or the social fragility. Our data suggest that young foreigners, the homeless, and the people with low social and economic status are at higher risk of an unfavorable outcome in low incidence TB countries. Targeted actions to support this highly vulnerable population both in terms of outcome and occurrence of adverse events are needed.


Subject(s)
COVID-19 , Tuberculosis, Pulmonary , Adolescent , Adult , Aged , Aged, 80 and over , Antitubercular Agents/adverse effects , Delayed Diagnosis , Hospitals , Humans , Middle Aged , Pandemics , Referral and Consultation , Retrospective Studies , Tuberculosis, Pulmonary/drug therapy , Tuberculosis, Pulmonary/epidemiology , Young Adult
7.
Sci Rep ; 12(1): 5736, 2022 04 06.
Article in English | MEDLINE | ID: covidwho-1778634

ABSTRACT

The aims of this study were to characterize new SARS-CoV-2 genomes sampled all over Italy and to reconstruct the origin and the evolutionary dynamics in Italy and Europe between February and June 2020. The cluster analysis showed only small clusters including < 80 Italian isolates, while most of the Italian strains were intermixed in the whole tree. Pure Italian clusters were observed mainly after the lockdown and distancing measures were adopted. Lineage B and B.1 spread between late January and early February 2020, from China to Veneto and Lombardy, respectively. Lineage B.1.1 (20B) most probably evolved within Italy and spread from central to south Italian regions, and to European countries. The lineage B.1.1.1 (20D) developed most probably in other European countries entering Italy only in the second half of March and remained localized in Piedmont until June 2020. In conclusion, within the limitations of phylogeographical reconstruction, the estimated ancestral scenario suggests an important role of China and Italy in the widespread diffusion of the D614G variant in Europe in the early phase of the pandemic and more dispersed exchanges involving several European countries from the second half of March 2020.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , Communicable Disease Control , Europe/epidemiology , Genome, Viral/genetics , Humans , Italy/epidemiology , Phylogeography , SARS-CoV-2/genetics
8.
Clin Infect Dis ; 73(11): e4031-e4038, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1559750

ABSTRACT

BACKGROUND: Prolonged QTc intervals and life-threatening arrhythmias (LTA) are potential drug-induced complications previously reported with antimalarials, antivirals, and antibiotics. Our objective was to evaluate the prevalence and predictors of QTc interval prolongation and incidences of LTA during hospitalization for coronavirus disease 2019 (COVID-19) among patients with normal admission QTc. METHODS: We enrolled 110 consecutive patients in a multicenter international registry. A 12-lead electrocardiograph was performed at admission, after 7, and at 14 days; QTc values were analyzed. RESULTS: After 7 days, 15 (14%) patients developed a prolonged QTc (pQTc; mean QTc increase 66 ± 20 msec; +16%; P < .001); these patients were older and had higher basal heart rates, higher rates of paroxysmal atrial fibrillation, and lower platelet counts. The QTc increase was inversely proportional to the baseline QTc level and leukocyte count and directly proportional to the basal heart rate (P < .01).We conducted a multivariate stepwise analysis including age, male gender, paroxysmal atrial fibrillation, basal QTc values, basal heart rate, and dual antiviral therapy; age (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.13; P < .05), basal heart rate (OR, 1.07; 95% CI, 1.02-1.13; P < .01), and dual antiviral therapy (OR, 12.46; 95% CI, 2.09-74.20; P < .1) were independent predictors of QT prolongation.The incidence rate of LTA during hospitalization was 3.6%. There was 1 patient who experienced cardiac arrest and 3 with nonsustained ventricular tachycardia. LTAs were recorded after a median of 9 days from hospitalization and were associated with 50% of the mortality rate. CONCLUSIONS: After 7 days of hospitalization, 14% of patients with COVID-19 developed pQTc; age, basal heart rate, and dual antiviral therapy were found to be independent predictors of pQTc. Life-threatening arrhythmias have an incidence rate of 3.6%, and were associated with a poor outcome.


Subject(s)
COVID-19 , Long QT Syndrome , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/etiology , Electrocardiography , Hospitalization , Humans , Male , Registries , SARS-CoV-2
9.
Minerva Med ; 113(4): 667-674, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1513375

ABSTRACT

BACKGROUND: Cardiac involvement significantly contributes to coronavirus disease 2019 (COVID-19) mortality.12-lead electrocardiogram (ECG) represents a fast, cheap, and easy to perform exam with the adjunctive advantage of the remote reporting possibility. In this study, we sought to investigate if electrocardiographic parameters can identify patients, deemed at low-risk at admission, who will face in-hospital unfavorable course. METHODS: From March 1, 2020, through March 30, 2021, 384 consecutive patients with confirmed low-risk COVID-19 were hospitalized at the University Hospital of Bari (Italy). Criteria for low risk were: admission to the division of Pneumology or Infectious Diseases, no need for immediate (within 24 hours from admission) transfer to Intensive Care Unit or for respiratory support with invasive mechanical ventilation (IMV) or for circulation support (either mechanical or pharmacological). Admission ECGs were reviewed and interpreted by two expert cardiologists. The primary outcomes were in-hospital death and the composite outcome of in-hospital death and IMV. RESULTS: In low-risk COVID-19 patients, atrial fibrillation (AF), poor R wave progression (PRWP), tachycardia, and right bundle branch block (RBBB) resulted as statistically significant and independent predictors of in-hospital all-cause mortality; AF, PRWP, Tachycardia, RBBB, and corrected QT interval showed to be statistically significant and independent risk factors for the occurrence of the composite endpoint of death and IMV. CONCLUSIONS: Our study demonstrated for the first time that RBBB and PRWP, assessed upon admission with ECG, are associated with unfavorable clinical course in a baseline low-risk population hospitalized for COVID-19.


Subject(s)
COVID-19 , Bundle-Branch Block/epidemiology , COVID-19/diagnosis , Electrocardiography , Hospital Mortality , Humans , Prognosis , Tachycardia
10.
J Med Virol ; 93(5): 3158-3164, 2021 May.
Article in English | MEDLINE | ID: covidwho-1085668

ABSTRACT

Data regarding the immunological memory and long-time kinetics of immunoglobulin (IgG) against viral nucleoprotein (NP) and spike protein S1 receptor-binding domain (S1RBD) of Severe Acute Respiratory Syndrome-associated Coronavirus 2 (SARS-CoV-2) are lacking. All consecutive COVID-19 patients admitted to our Clinic between March 1, 2020, and May 1, 2020, who were tested at hospital admission for anti-S1RBD and anti-NP IgG were enrolled. Serum samples were tested for anti-SARS-CoV-2 antibodies with the use of two commercially available enzyme-linked immunosorbent assays. Results are expressed as optical density measurements at 450 nm (OD450 ). Overall, 111 patients were included; the median (q1-q3) age was 57 (49-73) years, 59 (53%) males. According to disease severity, 31 (28%), 47 (42%), and 33 (30%) patients were considered affected by mild/moderate, severe, and critical SARS-CoV-2 infection, respectively. During hospitalization, patients with the critical disease showed a higher peak value of both anti-NP (median OD450 : 3.66 vs. 3.06 vs. 3.00 respectively, p = .043) and anti-S1RBD IgG (median OD450 : 2.33 vs. 1.6 vs. 0.91, respectively, p < .001). By testing 48 subjects 6 months or above from discharge, a significant decrease of anti-NP IgG was observed (r: -0.5838; p < .0001), whereas anti-S1RBD IgG showed only a modest reduction (r: -0.1507; p = .0647). Accordingly, 10 (21%) and 2 (4%) patients had a negative serological status for anti-NP and anti-S1RBD IgG, respectively; no association with clinical severity was found. IgGs against SARS-CoV-2 persisted several months after discharge, regardless of disease severity, suggesting that vaccination could be a valid strategy to fight the pandemic.


Subject(s)
Antibodies, Viral/physiology , COVID-19/immunology , COVID-19/pathology , SARS-CoV-2/immunology , Spike Glycoprotein, Coronavirus/immunology , Aged , Female , Humans , Male , Middle Aged , Protein Binding , Protein Domains , SARS-CoV-2/metabolism
11.
Clin Exp Med ; 21(2): 249-268, 2021 May.
Article in English | MEDLINE | ID: covidwho-1068751

ABSTRACT

There is limited information on the presenting characteristics, prognosis, and therapeutic approaches of young patients hospitalized for coronavirus disease 2019 (COVID-19). We sought to investigate the baseline characteristics, in-hospital treatment, and outcomes of a wide cohort < 65 years admitted for COVID-19. Using the international multicenter HOPE-COVID-19 registry, we evaluated the baseline characteristics, clinical presentation, therapeutic approach, and prognosis of patients < 65 years discharged (deceased or alive) after hospital admission for COVID-19, also compared with the elderly counterpart. Of the included 5746 patients, 2676 were < 65 and 3070 ≥ 65 years. All risk factors and several parameters suggestive of worse clinical presentation augmented through increasing age classes. In-hospital mortality rates were 6.8% and 32.1% in the younger and older cohort, respectively (p < 0.001). Among young patients, mortality, access to ICU and treatment with IMVwere positively correlated with age. Contrariwise, over 65 years of age this trend was broken so that only the association between age and mortality was persistent, while the rates of access to ICU and IMV started to decline. Younger patients also recognized specific predictors of case fatality, such as obesity and gender. Age negatively impacts on mortality, access to ICU and treatment with IMV in patients < 65 years. In elderly patients only case fatality rate keeps augmenting in a stepwise manner through increasing age categories, while therapeutic approaches become more conservative. Besides age, obesity, gender, history of cancer, and severe dyspnea, tachypnea, chest X-ray bilateral abnormalities, abnormal level of creatinine and leucocyte among admission parameters seem to play a central role in the outcome of patients younger than 65 years.


Subject(s)
Aging , COVID-19/diagnosis , COVID-19/mortality , Adult , Age Factors , Aged , Aged, 80 and over , Antiviral Agents/therapeutic use , Comorbidity , Female , Humans , Male , Middle Aged , Registries , Retrospective Studies , SARS-CoV-2/drug effects , Treatment Outcome , Young Adult , COVID-19 Drug Treatment
12.
Intern Emerg Med ; 16(4): 957-966, 2021 06.
Article in English | MEDLINE | ID: covidwho-915237

ABSTRACT

Recently the coronavirus disease (COVID-19) outbreak has been declared a pandemic. Despite its aggressive extension and significant morbidity and mortality, risk factors are poorly characterized outside China. We designed a registry, HOPE COVID-19 (NCT04334291), assessing data of 1021 patients discharged (dead or alive) after COVID-19, from 23 hospitals in 4 countries, between 8 February and 1 April. The primary end-point was all-cause mortality aiming to produce a mortality risk score calculator. The median age was 68 years (IQR 52-79), and 59.5% were male. Most frequent comorbidities were hypertension (46.8%) and dyslipidemia (35.8%). A relevant heart or lung disease were depicted in 20%. And renal, neurological, or oncological disease, respectively, were detected in nearly 10%. Most common symptoms were fever, cough, and dyspnea at admission. 311 patients died and 710 were discharged alive. In the death-multivariate analysis, raised as most relevant: age, hypertension, obesity, renal insufficiency, any immunosuppressive disease, 02 saturation < 92% and an elevated C reactive protein (AUC = 0.87; Hosmer-Lemeshow test, p > 0.999; bootstrap-optimist: 0.0018). We provide a simple clinical score to estimate probability of death, dividing patients in four grades (I-IV) of increasing probability. Hydroxychloroquine (79.2%) and antivirals (67.6%) were the specific drugs most commonly used. After a propensity score adjustment, the results suggested a slight improvement in mortality rates (adjusted-ORhydroxychloroquine 0.88; 95% CI 0.81-0.91, p = 0.005; adjusted-ORantiviral 0.94; 95% CI 0.87-1.01; p = 0.115). COVID-19 produces important mortality, mostly in patients with comorbidities with respiratory symptoms. Hydroxychloroquine could be associated with survival benefit, but this data need to be confirmed with further trials. Trial Registration: NCT04334291/EUPAS34399.


Subject(s)
COVID-19/mortality , Aged , COVID-19/complications , COVID-19/therapy , Female , Hospitalization , Humans , Italy , Male , Middle Aged , Propensity Score , Registries , Risk Assessment , Risk Factors , Spain , Survival Rate
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