Clinical utility of circulating calprotectin to assist prediction and monitoring of COVID-19 severity: An Italian study.

BACKGROUND: Calprotectin (S100A8/A9) has been identified as a biomarker that can aid in predicting the severity of disease in COVID-19 patients. This study aims to evaluate the correlation between levels of circulating calprotectin (cCP) and the severity of COVID-19. METHODS: Sera from 245 COVID-19 patients and 110 apparently healthy individuals were tested for calprotectin levels using a chemiluminescent immunoassay (Inova Diagnostics). Intensive care unit (ICU) admission and type of respiratory support administered were used as indicators of disease severity, and their correlation with calprotectin levels was assessed. RESULTS: Samples from patients in the ICU had a median calprotectin concentration of 11.6 µg/ml as compared to 3.5 µg/ml from COVID-19 patients who were not in the ICU. The median calprotectin concentration in a cohort of healthy individuals collected before the COVID-19 pandemic was 3.0 µg/ml (95% CI: 2.820-2.969 µg/ml). Patients requiring a Venturi mask, continuous positive airway pressure, or orotracheal intubation all had significantly higher values of calprotectin than controls, with the increase of cCP levels proportional to the increasing need of respiratory support. CONCLUSION: Calprotectin levels in serum correlate well with disease severity and represent a promising serological biomarker for the risk assessment of COVID-19 patients.

Predictors of poor outcome in tocilizumab treated patients with Sars-CoV-2 related severe respiratory failure: A multicentre real world study.

INTRODUCTION: Despite Tocilizumab is now recognized as a concrete therapeutic option in patients with severe SARS-CoV-2 related respiratory failure, literature lacks about factors influencing the response to it in this context. Therefore, the aim of our study was to provide evidence about predictors of poor outcome in Tocilizumab treated patients in the real-world practice. MATERIALS AND METHODS: We retrospectively analyzed clinical, laboratory and chest computer tomography (CCT) data of patients firstly admitted in non Intensive Care Units (ICU) and suffering from severe respiratory failure, who were treated with the IL-6 antagonist Tocilizumab. We compared patients who died and/or required admission to ICU with oro-tracheal intubation (OTI) with those who did not. RESULTS: Two hundreds and eighty-seven patients (29.9% females) with mean age ± SD 64.1 ± 12.6 years were the study population. In-hospital mortality was 18.8%, while the composite endpoint in-hospital mortality and/or ICU admission with OTI occurred in 23.7%. At univariate analysis, patients who died and/or were admitted to ICU with OTI were significantly older and co-morbid, had significantly higher values of creatinine, C-reactive protein (CRP) and procalcitonin and lower lymphocytes count, PaO2/FiO2 ratio (P/F) and room air pulsossimetry oxygen saturation (RAO2S) at hospital admission. Computed tomography ground glass opacities (CT-GGO) involving the pulmonary surface ≥ 50% were found in 55.4% of patients who died and/or were admitted to ICU with OTI and in 21.5% of patients who did not (p=0.0001). At multivariate analysis, age ≥ 65 years (OR 17.3, 95% CI: 3.7-81.0), procalcitonin ≥ 0.14 (OR 9.9, 95%CI: 1.7-56.1), RAO2S ≤ 90% (OR 4.6, 95%CI: 1.2-17.0) and CCT-GGO involvement ≥ 50% (OR 5.1, 95%CI: 1.2-21.0) were independent risk factors associated with death and/or ICU admission with OTI. CONCLUSION: Tocilizumab has shown to improve outcome in patients with severe respiratory failure associated to SARS-CoV-2 related pneumonia. In our multicentre study focusing on Tocilizumab treated severe COVID-19 patients, age ≥ 65 years, procalcitonin ≥ 0.14 ng/mL, RAO2S ≤ 90% and CCT-GGO involvement ≥ 50% were independent factors associated with poor outcome.

One-year evolution of DLCO changes and respiratory symptoms in patients with post COVID-19 respiratory syndrome.

PURPOSE: During a follow-up program of patients admitted for COVID-19 at our non-ICU Unit, we found that 37% of them had decreased diffusing lung capacity for carbon monoxide (DLCO) 3-6 months after discharge. This prospective observational study aimed to evaluate the evolution of changes in DLCO and respiratory symptoms at the 1-year follow-up visit. METHODS: Seventeen (mean age 71 years; 8 males) of 19 eligible patients (DLCO < 80% of predicted at the 3-6 months follow-up visit) completed the 1-year follow-up visit. One patient refused to participate and 1 patient had died 3 months earlier from myocardial infarction. The visit included a self-reported structured questionnaire, physical exam, blood tests, ECG, and spirometry with DLCO. RESULTS: Mean DLCO was significantly improved at the 1-year visit (from 64% of predicted at 3-6 months to 74% of predicted at 1 year; P = 0.003). A clinically significant increase in DLCO (10% or greater) was observed in 11 patients (65%) with complete normalization (> 80% of predicted) in 6 (35%); in the other 6 (35%) it remained unchanged. The prevalence of exertional dyspnea (65-35%, P = 0.17), cough (24-18%, P = 1), and fatigue (76-35%, P = 0.04) decreased at the 1-year visit. CONCLUSION: These results suggest that DLCO and respiratory symptoms tend to normalize or improve 1 year after hospitalization for COVID-19 in most patients. However, there is also a non-negligible number of patients (about one-third) in whom respiratory changes persist and will need prolonged follow-up.

Course and Lethality of SARS-CoV-2 Epidemic in Nursing Homes after Vaccination in Florence, Italy.

Evidence on the effectiveness of SARS-CoV-2 vaccines in nursing home (NHs) residents is limited. We examined the impact of the BNT162b2 mRNA SARS-CoV-2 vaccine on the course of the epidemic in NHs in the Florence Health District, Italy, before and after vaccination. Moreover, we assessed survival and hospitalization by vaccination status in SARS-CoV-2-positive cases occurring during the post-vaccination period. We calculated the weekly infection rates during the pre-vaccination (1 October-26 December 2020) and post-vaccination period (27 December 2020-31 March 2021). Cox analysis was used to analyze survival by vaccination status. The study involved 3730 residents (mean age 84, 69% female). Weekly infection rates fluctuated during the pre-vaccination period (1.8%-6.5%) and dropped to zero during the post-vaccination period. Nine unvaccinated (UN), 56 partially vaccinated (PV) and 35 fully vaccinated (FV) residents tested SARS-CoV-2+ during the post-vaccination period. FV showed significantly lower hospitalization and mortality rates than PV and UV (hospitalization: FV 3%, PV 14%, UV 33%; mortality: FV 6%, PV 18%, UV 56%). The death risk was 84% and 96% lower in PV (HR 0.157, 95%CI 0.049-0.491) and FV (HR 0.037, 95%CI 0.006-0.223) versus UV. SARS-CoV-2 vaccination was followed by a marked decline in infection rates and was associated with lower morbidity and mortality among infected NH residents.

Caring for nursing home residents with COVID-19: a "hospital-at-nursing home" intermediate care intervention.

BACKGROUND: Nursing home (NH) residents have been dramatically affected by COVID-19, with extremely high rates of hospitalization and mortality. AIMS: To describe the features and impact of an assistance model involving an intermediate care mobile medical specialist team (GIROT, Gruppo Intervento Rapido Ospedale Territorio) aimed at delivering "hospital-at-nursing home" care to NH residents with COVID-19 in Florence, Italy. METHODS: The GIROT activity was set-up during the first wave of the pandemic (W1, March-April 2020) and became a structured healthcare model during the second (W2, October 2020-January 2021). The activity involved (1) infection transmission control among NHs residents and staff, (2) comprehensive geriatric assessment including prognostication and geriatric syndromes management, (3) on-site diagnostic assessment and protocol-based treatment of COVID-19, (4) supply of nursing personnel to understaffed NHs. To estimate the impact of the GIROT intervention, we reported hospitalization and infection lethality rates recorded in SARS-CoV-2-positive NH residents during W1 and W2. RESULTS: The GIROT activity involved 21 NHs (1159 residents) and 43 NHs (2448 residents) during W1 and W2, respectively. The percentage of infected residents was higher in W2 than in W1 (64.5% vs. 38.8%), while both hospitalization and lethality rates significantly decreased in W2 compared to W1 (10.1% vs 58.2% and 23.4% vs 31.1%, respectively). DISCUSSION: Potentiating on-site care in the NHs paralleled a decrease of hospital admissions with no increase of lethality. CONCLUSIONS: An innovative "hospital-at-nursing home" patient-centred care model based on comprehensive geriatric assessment may provide a valuable contribution in fighting COVID-19 in NH residents.

Admission Braden Scale Score as an Early Independent Predictor of In-Hospital Mortality Among Inpatients With COVID-19: A Retrospective Cohort Study.

BACKGROUND: The COVID-19 pandemic has put a strain on health systems. Predictors of adverse outcomes need to be investigated to properly manage COVID-19 patients. The Braden Scale (BS), commonly used for the assessment of pressure ulcer risk, has recently been proposed to identify frailty. OBJECTIVE: To investigate the predictive utility of the BS for prediction of in-hospital mortality in a cohort of COVID-19 patients admitted to non-ICU wards. METHODS: We conducted a retrospective single-center cohort study evaluating all patients with SARS-CoV-2 infection consecutively admitted over a 2-month period (from March 6 to May 7, 2020) to the COVID-19 general wards of our institution. Demographic, clinical, and nursing assessment data, including admission BS, were extracted from electronic medical records. Univariable and multivariable logistic regression models were used to explore the association between the BS score and in-hospital death. RESULTS: Braden Scale was assessed in 146 patients (mean age 74.7 years; 52% males). On admission, 46 had a BS ≤ 15, and 100 patients had a BS > 15. Mortality among patients with BS ≤ 15 was significantly higher than in patients with BS > 15 (45.7% vs. 16%; p < .001). On multivariable regression analysis, adjusting for potentials confounders (age, Barthel scale, chronic kidney disease, atrial fibrillation, and hypertension), the admission BS remained inversely associated with the risk of in-hospital mortality (OR = 0.76; 95% CI [0.60, 0.96]; p = .020). LINKING EVIDENCE TO ACTION: Admission BS could be used as a simple bedside predictive tool able to early identify non-ICU COVID-19 patients with poor prognosis who might benefit from specific and timely interventions.

COVID-19: persistence of symptoms and lung alterations after 3-6 months from hospital discharge.

PURPOSE: Few data are currently available on persistent symptoms and late organ damage in patients who have suffered from COVID-19. This prospective study aimed to evaluate the results of a follow-up program for patients discharged from a nonintensive COVID-19 ward. METHODS: 3-6 months after hospital discharge, 59 of 105 COVID-19 patients (31 males, aged 68.2 ± 12.8 years) were recruited in the study. Forty-six patients were excluded because of nontraceability, refusal, or inability to provide informed consent. The follow-up consisted of anamnesis (including a structured questionnaire), physical examination, blood tests, ECG, lower limb compression venous ultrasound (US), thoracic US, and spirometry with diffusion lung capacity for carbon monoxide (DLCO). RESULTS: 22% of patients reported no residual symptoms, 28.8% 1 or 2 symptoms and 49.2% 3 or more symptoms. The most frequently symptoms were fatigue, exertional dyspnea, insomnia, and anxiety. Among the inflammatory and coagulation parameters, only the median value of fibrinogen was slightly above normal. A deep vein thrombosis was detected in 1 patient (1.7%). Thoracic US detected mild pulmonary changes in 15 patients (25.4%), 10 of which reported exertional dyspnea. DLCO was mildly or moderately reduced in 19 patients (37.2%), 13 of which complained of exertional dyspnea. CONCLUSION: These results highlight that a substantial percentage of COVID-19 patients (77.8%) continue to complain of symptoms 3-6 months after hospital discharge. Exertional dyspnea was significantly associated with the persistence of lung US abnormalities and diffusing capacity alterations. Extended follow-up is required to assess the long-term evolution of postacute sequelae of COVID-19.

Incidence of deep vein thrombosis through an ultrasound surveillance protocol in patients with COVID-19 pneumonia in non-ICU setting: A multicenter prospective study.

OBJECTIVE: The aim of this study was to assess the incidence of deep vein thrombosis (DVT) of the lower limbs, using serial compression ultrasound (CUS) surveillance, in acutely ill patients with COVID-19 pneumonia admitted to a non-ICU setting. METHODS: Multicenter, prospective study of patients with COVID-19 pneumonia admitted to Internal Medicine units. All patients were screened for DVT of the lower limbs with serial CUS. Anticoagulation was defined as: low dose (enoxaparin 20-40 mg/day or fondaparinux 1.5-2.5 mg/day); intermediate dose (enoxaparin 60-80 mg/day); high dose (enoxaparin 120-160 mg or fondaparinux 5-10 mg/day or oral anticoagulation). The primary end-point of the study was the diagnosis of DVT by CUS. RESULTS: Over a two-month period, 227 consecutive patients with moderate-severe COVID-19 pneumonia were enrolled. The incidence of DVT was 13.7% (6.2% proximal, 7.5% distal), mostly asymptomatic. All patients received anticoagulation (enoxaparin 95.6%) at the following doses: low 57.3%, intermediate 22.9%, high 19.8%. Patients with and without DVT had similar characteristics, and no difference in anticoagulant regimen was observed. DVT patients were older (mean 77±9.6 vs 71±13.1 years; p = 0.042) and had higher peak D-dimer levels (5403 vs 1723 ng/mL; p = 0.004). At ROC analysis peak D-dimer level >2000 ng/mL (AUC 0.703; 95% CI 0.572-0.834; p = 0.004) was the most accurate cut-off value able to predict DVT (RR 3.74; 95%CI 1.27-10, p = 0.016). CONCLUSIONS: The incidence of DVT in acutely ill patients with COVID-19 pneumonia is relevant. A surveillance protocol by serial CUS of the lower limbs is useful to timely identify DVT that would go otherwise largely undetected.

Effectiveness and safety of noninvasive positive pressure ventilation in the treatment of COVID-19-associated acute hypoxemic respiratory failure: a single center, non-ICU setting experience.

The role of noninvasive positive pressure ventilation (NIPPV) in COVID-19 patients with acute hypoxemic respiratory failure (AHRF) is uncertain, as no direct evidence exists to support NIPPV use in such patients. We retrospectively assessed the effectiveness and safety of NIPPV in a cohort of COVID-19 patients consecutively admitted to the COVID-19 general wards of a medium-size Italian hospital, from March 6 to May 7, 2020. Healthcare workers (HCWs) caring for COVID-19 patients were monitored, undergoing nasopharyngeal swab for SARS-CoV-2 in case of onset of COVID-19 symptoms, and periodic SARS-CoV-2 screening serology. Overall, 50 patients (mean age 74.6 years) received NIPPV, of which 22 (44%) were successfully weaned, avoiding endotracheal intubation (ETI) and AHRF-related death. Due to limited life expectancy, 25 (50%) of 50 NIPPV-treated patients received a "do not intubate" (DNI) order. Among these, only 6 (24%) were weaned from NIPPV. Of the remaining 25 NIPPV-treated patients without treatment limitations, 16 (64%) were successfully weaned, 9 (36%) underwent delayed ETI and, of these, 3 (33.3%) died. NIPPV success was predicted by the use of corticosteroids (OR 15.4, CI 1.79-132.57, p 0.013) and the increase in the PaO2/FiO2 ratio measured 24-48 h after NIPPV initiation (OR 1.02, CI 1-1.03, p 0.015), while it was inversely correlated with the presence of a DNI order (OR 0.03, CI 0.001-0.57, p 0.020). During the study period, 2 of 124 (1.6%) HCWs caring for COVID-19 patients were diagnosed with SARS-CoV-2 infection. Apart from patients with limited life expectancy, NIPPV was effective in a substantially high percentage of patients with COVID-19-associated AHRF. The risk of SARS-CoV-2 infection among HCWs was low.