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The most beneficial effect of corticosteroid therapy in COVID-19 patients has been shown in subjects receiving invasive mechanical ventilation (IMV), corresponding to a score of 6 on the World Health Organization (WHO) COVID-19 Ordinal Scale for Clinical Improvement (OSCI). The aim of this observational, single-center, prospective study was to assess the association between corticosteroids and hospital mortality in coronavirus disease 2019 (COVID-19) patients who did not receive IMV (OSCI 3-5). Included were 1,311 COVID-19 patients admitted to nonintensive care wards, and they were divided in two cohorts: (i) 480 patients who received corticosteroid therapy and (ii) 831 patients who did not. The median daily dose was of 8 mg of dexamethasone or equivalent, with a mean therapy duration of 5 (3-9) days. The indication to administer or withhold corticosteroids was given by the treating physician. In-hospital mortality was similar between the two cohorts after adjusting for possible confounders (adjusted odds ratio (ORadj) 1.04, 95% confidence interval (CI), 0.81-1.34, P = 0.74). There was also no difference in Intensive Care Unit (ICU) admission (ORadj 0.81, 95% CI, 0.56-1.17, P = 0.26). COVID-19 patients with noninvasive mechanical ventilation (NIMV) had a lower risk for ICU admission if they received steroid therapy (ORadj 0.58, 95% CI, 0.35-0.94, P = 0.03). In conclusion, corticosteroids were overall not associated with a difference in hospital mortality for patients with COVID-19 with OSCI 3-5. In the subgroup of patients with NIMV (OSCI 5), corticosteroids reduced ICU admission, whereas the effect on mortality requires further studies.

BACKGROUND: The ratio of dead space to tidal volume (VD/VT) is associated with mortality in patients with ARDS. Corrected minute ventilation ([Formula: see text]) is a simple surrogate of dead space, but, despite its increasing use, its association with mortality has not been proven. The aim of our study was to assess the association between [Formula: see text] and hospital mortality. We also compared the strength of this association with that of estimated VD/VT and ventilatory ratio.METHODS: We performed a retrospective study with prospectively collected data. We evaluated 187 consecutive mechanically ventilated subjects with ARDS caused by novel coronavirus disease (COVID-19). The association between [Formula: see text] and hospital mortality was assessed in multivariable logistic models. The same was done for estimated VD/VT and ventilatory ratio.RESULTS: Mean ± SD [Formula: see text] was 11.8 ± 3.3 L/min in survivors and 14.5 ± 3.9 L/min in nonsurvivors (P < .001) and was independently associated with mortality (adjusted odds ratio 1.15, P = .01). The strength of association of [Formula: see text] with mortality was similar to that of VD/VT and ventilatory ratio.CONCLUSIONS: [Formula: see text] was independently associated with hospital mortality in subjects with ARDS caused by COVID-19. [Formula: see text] could be used at the patient's bedside for outcome prediction and severity stratification, due to the simplicity of its calculation. These findings need to be confirmed in subjects with ARDS without viral pneumonia and when lung-protective mechanical ventilation is not rigorously applied.

The Pfizer/BioNtech Comirnaty vaccine (BNT162b2 mRNA COVID-19) against SARS-CoV-2 is currently in use in Italy. Antibodies to evaluate SARS-CoV-2 infection prior to administration are not routinely tested, therefore, two doses may be administered to asymptomatic previously exposed subjects. The aim of this study is to assess if any difference in antibody concentration between subjects exposed and not exposed to SARS-CoV-2 prior to BNT162b2 was present after the first dose and after the second dose of vaccine. Data were retrospectively collected from the clinical documentation of 337 healthcare workers who underwent SARS-CoV-2 testing before and after BNT162b2. Total anti RBD (receptor-binding domain) antibodies against SARS-CoV-2′s spike protein were measured before and 21 days after the first dose, and 12 days after the second dose of BNT162b2. Twenty-one days after the first dose, there was a statistically significant difference in antibody concentration between the two groups, which was also maintained twelve days after the second dose. In conclusion, antibody response after receiving BNT162b2 is greater in subjects who have been previously exposed to SARS-CoV-2 than in subjects who have not been previously exposed to the virus, both after 21 days after the first dose and after 12 days from the second dose. Antibody levels, 21 days after the first dose, reached a titer considered positive by the test manufacturer in the majority of subjects who have been previously infected with SARS-CoV-2. Evaluating previous infection prior to vaccination in order to give the least effective number of doses should be considered.

OBJECTIVES: Early tracheotomy, defined as a procedure performed within 10 days from intubation, is associated with more ventilator free days, shorter ICU stay, and lower mortality than late tracheotomy. During the coronavirus disease 2019 pandemic, it was especially important to save operating room resources and to have a shorter ICU stay for patients, when ICUs had insufficient beds. In this context of limited resources, early percutaneous tracheostomy could be an effective way to manage mechanically ventilated patients. Nevertheless, current recommendations suggest delaying or avoiding the tracheotomy in coronavirus disease 2019 patients. Aim of the study was to analyze the hospital mortality of coronavirus disease 2019 patients who had received early percutaneous tracheostomy and factors associated with removal of tracheostomy cannula at ICU discharge.DESIGN: Cohort study.SETTING: Coronavirus disease 2019 ICU.PATIENTS: Adult patients with coronavirus disease 2019 3 days after ICU admission.INTERVENTIONS: None.MEASUREMENTS AND MAIN RESULTS: Three days after ICU admission, 164 patients were present in ICU and included in the analysis. One-hundred and twenty-one patients (74%) were tracheostomized, whereas the other 43 (26%) were managed with translaryngeal intubation only. In multivariable analysis, early percutaneous tracheostomy was associated with lower hospital mortality. Sixty-six of tracheostomized patients (55%) were discharged alive from the hospital. Age and male sex were the only characteristics that were independently associated with mortality in the tracheostomized patients (45.5% and 62.8% in tracheostomized and nontracheostomized patients, respectively; p = 0.009). Tracheostomy tube was removed in 47 of the tracheostomized patients (71%). The only variable independently associated with weaning from tracheostomy at ICU discharge was a faster start of spontaneous breathing after tracheotomy was performed.CONCLUSIONS: Early percutaneous tracheostomy was safe and effective in coronavirus disease 2019 patients, giving a good chance of survival and of weaning from tracheostomy cannula at ICU discharge.

Since the start of the novel coronavirus 2019 (COVID-19) pandemic, corticosteroid use has been the subject of debate. The available evidence is uncertain, and knowledge on the subject is evolving. The aim of our cohort study was to evaluate the association between corticosteroid therapy and hospital mortality, in patients hospitalized with COVID-19 after balancing for possible confounders. One thousand four hundred forty four patients were admitted to our hospital with a positive RT-PCR test for SARS-CoV-2, 559 patients (39%) were exposed to corticosteroids during hospital stay, 844 (61%) were not exposed to corticosteroids. In the cohort of patients exposed to corticosteroids, 171 (30.6%) died. In the cohort of patients not exposed to corticosteroids, 183 (21.7%) died (unadjusted p p = 0.25). Patients in the corticosteroids cohort had a reduced risk of ICU admission (adjusted p

Background The evaluation of patient effort is pivotal during pressure support ventilation, but a non-invasive, continuous, quantitative method to assess patient inspiratory effort is still lacking. We hypothesized that the concavity of the inspiratory flow-time waveform could be useful to estimate patient’s inspiratory effort. The purpose of this study was to assess whether the shape of the inspiratory flow, as quantified by a numeric indicator, could be associated with inspiratory effort during pressure support ventilation. Methods Twenty-four patients in pressure support ventilation were enrolled. A mathematical relationship describing the decay pattern of the inspiratory flow profile was developed. The parameter hypothesized to estimate effort was named Flow Index. Esophageal pressure, airway pressure, airflow, and volume waveforms were recorded at three support levels (maximum, minimum and baseline). The association between Flow Index and reference measures of patient effort (pressure time product and pressure generated by respiratory muscles) was evaluated using linear mixed effects models adjusted for tidal volume, respiratory rate and respiratory rate/tidal volume. Results Flow Index was different at the three pressure support levels and all group comparisons were statistically significant. In all tested models, Flow Index was independently associated with patient effort (p Flow Index prediction of inspiratory effort agreed with esophageal pressure-based methods. Conclusions Flow Index is associated with patient inspiratory effort during pressure support ventilation, and may provide potentially useful information for setting inspiratory support and monitoring patient-ventilator interactions.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to widespread use of hydroxychloroquine and azithromycin despite the lack of conclusive evidence for their safety and efficacy. We evaluated the association between treatment with hydroxychloroquine and/or azithromycin and hospital mortality as the primary outcome. We compared the hospital mortality of patients treated with hydroxychloroquine alone, azithromycin alone, or their combination to the mortality of patients who received neither drug. A logistic multivariate model with overlap weight propensity score was used for estimation of odds ratios (ORs) with 95% confidence intervals (95% CIs). One thousand four hundred and three patients with SARS-CoV-2 infection were admitted to the hospital. At the time of the analysis, the outcome was available for 1376 (98%) of them. Five hundred and eighty-seven patients (42%) received azithromycin and 377 patients (27%) received hydroxychloroquine, alone or in combination. In-hospital mortality was 26%. After the adjusted analysis, azithromycin alone was associated with lower mortality (OR 0.60, 95% CI 0.42&ndash, 0.85) compared to no treatment. Hydroxychloroquine alone (OR 0.76, 95% CI 0.53&ndash, 1.08) and the combination of azithromycin and hydroxychloroquine (OR 1.13, 95% CI 0.77&ndash, 1.69) were not associated with hospital mortality. In this cohort of patients, azithromycin alone was associated with lower hospital mortality but hydroxychloroquine was not associated with increased or reduced mortality. While we await randomized clinical trials, these data support the use of azithromycin in novel coronavirus disease 2019 (COVID-19) and can contribute to better understanding of its role in further meta-analyses.

BackgroundSince the start of the novel coronavirus 2019 (COVID-19) pandemic, corticosteroid use has been the subject of debate. The available evidence is uncertain, and knowledge on the subject is evolving. The aim of our cohort study was to evaluate the association between corticosteroid therapy and hospital mortality, in patients hospitalized with COVID-19 after balancing for possible confounders.ResultsOne thousand four hundred forty four patients were admitted to our hospital with a positive RT-PCR test for SARS-CoV-2, 559 patients (39%) were exposed to corticosteroids during hospital stay, 844 (61%) were not exposed to corticosteroids.In the cohort of patients exposed to corticosteroids, 171 (30.6%) died. In the cohort of patients not exposed to corticosteroids, 183 (21.7%) died (unadjusted p ConclusionsTreatment with corticosteroids did not affect hospital mortality in patients with COVID-19 after balancing for confounders. A possible advantage of corticosteroid therapy was to reduce Intensive Care Unit admission, which could be useful in reducing pressure on the Intensive Care Units in times of limited resources, as during the COVID-19 pandemic.

BACKGROUND: Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection is associated with hypercoagulability caused by direct invasion of endothelial cells and\or proinflammatory cytokine release. Thromboprophylaxis with enoxaparin is recommended by current guidelines, but evidence is still weak. The aim of this study was to assess the impact of thromboprophylaxis with enoxaparin on hospital mortality in patients admitted for Coronavirus disease 2019 (COVID-19). The effects of enoxaparin on intensive care admission and hospital length-of-stay were evaluated as secondary outcomes.METHODS: Observational cohort study, with data collected from patients admitted to Poliambulanza Foundation with positive real time reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 from 20th February to 10th May 2020. Multivariate logistic regression with overlap weight propensity score was used to model hospital mortality and intensive care admission, hospital length-of-stay was analyzed with a multivariate Poisson regression. Seven hundred and ninety nine (57%) patients who received enoxaparin at least once during the hospitalization were included in the enoxaparin cohort, 604 (43%) patients who did not were included in the control cohort.FINDINGS: At the adjusted analysis enoxaparin was associated with lower in-hospital mortality (Odds Ratio 0·53, 95% C.I. 0·40-0·70) compared with no enoxaparin treatment. Hospital length-of-stay was longer for patients treated with enoxaparin (Incidence Rate Ratios 1·45, 95% C.I. 1·36-1·54). Enoxaparin treatment was associated with reduced risk of intensive care admission at the adjusted analysis (Odds Ratio 0·48, 95% C.I. 0·32-0·69).INTERPRETATION: This study shows that treatment with enoxaparin during hospital stay is associated with a lower death rate and, while results from randomized clinical trials are still pending, this study supports the use of thromboprophylaxis with enoxaparin in all patients admitted for COVID-19. Moreover, when enoxaparin is used on the wards, it reduces the risk of Intensive Care Unit admission.