Cross-sectional analysis of the humoral response after SARS-CoV-2 vaccination in Sardinian Multiple Sclerosis patients, a follow-up study (preprint)

Monitoring immune responses to SARS-CoV-2 vaccination and its clinical efficacy over time in Multiple Sclerosis (MS) patients treated with disease-modifying therapies (DMTs) help to establish the optimal strategies to ensure adequate COVID-19 protection without compromising disease control offered by DMTs. Following our previous observations of the humoral response one month after two doses of BNT162b2 vaccine (T1) in MS patients differently treated, here we present a cross-sectional and longitudinal follow-up analysis six months following vaccination (T2, n=662) and a month following the first booster (T3, n=185). Consistent with results at T1, humoral responses were decreased in MS patients treated with fingolimod and anti-CD20 therapies compared with untreated patients also at the time points considered here (T2 and T3). Interestingly, a strong upregulation one month after the booster was observed in patients under every DMTs analyzed, including those treated with fingolimod and anti-CD20 therapies. And although patients taking these latter therapies had a higher rate of COVID-19 infection five months after the first booster, only mild symptoms that did not require hospitalization were reported for all the DMTs analyzed here. Based on these findings we anticipate that additional vaccine booster shots will likely further improve immune responses and COVID-19 protection in MS patients treated with any DMT.

Role of ROX Index in the first assessment of COVID-19 patients in the Emergency Department (preprint)

Background: In Italy, since the first symptomatic cases of Coronavirus disease 2019 (COVID-19) appeared in late February 2020, 205.463 cases of Severe Acute Respiratory Syndrome 2 (SARS-CoV-2) were reported as of April 30, causing an high rate of hospital admission through the Emergency Department (ED).Objectives: The aim of the study was to evaluate the accuracy of ROX index in predicting hospitalization and mortality in patients with suspected diagnosis of COVID-19 in the ED. Secondary outcomes were to assess the number of readmissions and the variations of ROX index between first and second admission.Methods: This is an observational prospective monocentric study, conducted in the ED of Policlinico Sant’Orsola-Malpighi in Bologna. We enrolled 1371 consecutive patients with suspected COVID-19 and ROX index was calculated in 554 patients. Patients were followed until hospital discharge or death. Results: ROX index value < 25.7 was associated with hospitalization (AUC=0.737, 95%CI 0.696–0.779, p<0.001). ROX index < 22.3 is statistically related with higher 30-days mortality (AUC= 0.764, 95%CI 0.708-0.820, p<0.001). 8 patients were discharged and returned in the ED within the following 7 days, their mean ROX index was 30.3 (6.2; range 21.9-39.4) at the first assessment and 24.6 (5.5; 14.5-29.5) at the second assessment, (p=0.012).Conclusion: ROX index, together with laboratory, imaging and clinical findings, can help discriminate patients suspected for COVID-19 requiring hospital admission, their clinical severity and their mortality risk. Furthermore, it can be useful to better manage these patients in territorial healthcare services, especially in the hypothesis of another pandemic.

Non-COVID-19 patients in times of pandemic: decreased emergency department visits and increased out-of-hospital mortality in Northern Italy (preprint)

ObjectiveThe aim of this was to assess the short-term impact of the pandemic on non-COVID-19 patients living in a one-million inhabitants area in Northern Italy (Bologna Metropolitan Area-BMA), analyzing time trends of Emergency Department (ED) visits, hospitalizations and mortality. MethodsWe conducted a retrospective observational study using data extracted from BMA healthcare informative systems. Weekly trends of ED visits, hospitalizations, in- and out-of-hospital, all-cause and cause-specific mortality between December 1st, 2019 to May 31st, 2020, were compared with those of the same period of the previous year, using Joinpoint regression models and incidence rate ratios. ResultsNon-COVID-19 ED visits and hospitalizations showed a stable trend until the first Italian case of COVID-19 has been recorded, on February 19th, 2020, when they dropped simultaneously. The reduction of ED visits was observed in all age groups and across all severity and diagnosis groups. In the lockdown period a significant increase was found in overall out-of-hospital mortality (43.2%) and cause-specific out-of-hospital mortality related to neoplasms (76.7%), endocrine, nutritional and metabolic (79.5%) as well as cardiovascular (32.7%) diseases. ConclusionsThe pandemic caused a sudden drop of ED visits and hospitalizations of non-COVID-19 patients during the lockdown period, and a concurrent increase in out-of-hospital mortality mainly driven by deaths for neoplasms, cardiovascular and endocrine diseases. The findings of this study might be useful to understand both the population reaction and the healthcare system response at the early phases of the pandemic in terms of reduced demand of care and systems capability in intercepting it.

Alveolar-to-arterial oxygen gradient: role in the management of COVID-19 infection mild population (preprint)

COVID-19 infection is frequently associated with radiological diagnosis of interstitial pneumonia and alteration in gases exchange. We decided to test arterial blood gas assay parameters, in particular alveolar-to-arterial oxygen gradient (AaDO2), in predicting the need of hospitalization, the survival rate and in identifying pneumonia in patients with SARS-CoV-2 infection.We conducted an observational prospective study in one of the Emergency Department of our city. We included consecutive patients with symptoms likely related to SARS-CoV-2 infection, confirmed either with positive nasal pharyngeal swabs and/or with suggestive radiological findings. Areas under the curve of the receiver operator characteristic curve were computed to predict need of hospitalization and the presence of pneumonia. Survival curves were analyzed using a Log-rank test. P-value less than 0.05 were considered statistically significant.We enrolled 825 patients; the final population was composed by 530 patients. Most of them were hospitalized due to complications, the mortality was 14% but no death occured in the ED. It results that a threshold for AaDO2 of 27 could predict the need of hospitalization as well as a threshold for AaDO2 of 24 could identify the presence of pneumonia. Survival curves revealed that patients with a value of AaDO2 less than or equal to 40 had a better survival. We suggest the application of ABG parameters, in particular AaDO2, during the first assessment of COVID-19 patients in the ED, because they could be additional tools to help the emergency physician to evaluate the clinical severity of patients.The study was approved by our local ethics committee with the number 551/2020/Oss/AOUBo.

Non-COVID-19 Patients in Times of Pandemic: Decreased Emergency Department Visits and Increased Out-of-Hospital Mortality in Northern Italy (preprint)

Background: The COVID-19 pandemic forced healthcare services organization to adjust to healthcare needs of a mutating population. In this context, our aim was to assess the short-term impact of the pandemic on non-COVID-19 patients living in a one-million inhabitants area in Northern Italy (Bologna Metropolitan Area-BMA), analyzing time trends of ED visits, hospitalizations and mortality.Methods: We conducted a retrospective observational study using data extracted from BMA healthcare informative systems. Weekly trends of ED visits, hospitalizations, in- and out-of-hospital, all-cause and cause-specific mortality between December 1st, 2019 to May 31st, 2020, were compared with those of the same period of the previous year, using Joinpoint regression models and incidence rate ratios.Findings: Non-COVID-19 ED visits and hospitalizations showed a stable trend until the first Italian case hospitalized for COVID-19 has been recorded, on February 19th, 2020, when they dropped simultaneously with the growth of the SARS-CoV-2 curve. The marked reduction of ED visits was observed in all age groups and across all severity codes and diagnosis groups. In the lockdown period a significant increase was found in overall out-of-hospital mortality (43·2%) and cause-specific out-of-hospital mortality related to neoplasms (76·7%), endocrine, nutritional and metabolic (79·5%) as well as cardiovascular (32·7%) diseases.Interpretation: Our main finding is a sudden drop of ED visits and hospitalizations of non-COVID-19 patients during the pandemic and the concurrent increase in out-of-hospital mortality, particularly for neoplasms, cardiovascular and endocrine diseases. As a second phase of the COVID-19 pandemic is currently underway, the scenario described in this study might be useful to understand both the population reaction and the healthcare system response at the early phases of the pandemic in terms of reduced demand of care and systems capability in intercepting it.Fundings: This study received no specific funding.Declaration of Interests: All the authors declare no conflict of interests.Ethics Approval Statement: The study was approved by the Emilia Romagna Ethical Committee on August 3rd, 2020.