Virological surveillance of SARS-CoV-2 in an Italian Northern area: differences in gender, age and Real Time RT PCR cycle threshold (Ct) values in three epidemic periods.

BACKGROUND AND AIM OF THE WORK: Coronavirus Disease 2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global public health emergency. The aim of this study was to investigate cases characteristics and Real Time RT PCR cycle threshold (Ct) values distribution of COVID-19 in an Italian Northern area during three periods: first period, February-May 2020; second period, June-August 2020; third period, September 2020-February 2021. METHODS: Real Time RT PCR was used to detect SARS-CoV-2 in respiratory samples (oro/nasopharyngeal swabs). RESULTS: A total of 254,744 samples were tested during the study period. Out of 20,188 positive samples (7.92%), 10,303 were females (51.04%) and 9,885 were males (48.96%). The percentage of positivity varied during the three different periods: 14.1% in the first period, 1.4% in the second and 9.2% in the third. The lowest Ct values were observed in the first phase of pandemic, with an overall average of 25.64. Overall average of the Ct values was lower in males than in females, 26.29 ± 6.04 and 26.84 ± 5.99 respectively. The oldest patients recorded lower Ct values. CONCLUSIONS: The findings of our study represent further evidence in support of the fact that male sex and older age showed lower Ct values, which means higher viral loads and higher infectious potential. These knowledges are useful to better understand the epidemiological aspects of COVID-19 and to perform effective Public Health Policies.

Chest radiography or computed tomography for COVID-19 pneumonia? Comparative study in a simulated triage setting.

INTRODUCTION: For the management of patients referred to respiratory triage during the early stages of the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic, either chest radiography or computed tomography (CT) were used as first-line diagnostic tools. The aim of this study was to compare the impact on the triage, diagnosis and prognosis of patients with suspected COVID-19 when clinical decisions are derived from reconstructed chest radiography or from CT. METHODS: We reconstructed chest radiographs from high-resolution CT (HRCT) scans. Five clinical observers independently reviewed clinical charts of 300 subjects with suspected COVID-19 pneumonia, integrated with either a reconstructed chest radiography or HRCT report in two consecutive blinded and randomised sessions: clinical decisions were recorded for each session. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and prognostic value were compared between reconstructed chest radiography and HRCT. The best radiological integration was also examined to develop an optimised respiratory triage algorithm. RESULTS: Interobserver agreement was fair (Kendall's W=0.365, p<0.001) by the reconstructed chest radiography-based protocol and good (Kendall's W=0.654, p<0.001) by the CT-based protocol. NPV assisted by reconstructed chest radiography (31.4%) was lower than that of HRCT (77.9%). In case of indeterminate or typical radiological appearance for COVID-19 pneumonia, extent of disease on reconstructed chest radiography or HRCT were the only two imaging variables that were similarly linked to mortality by adjusted multivariable models CONCLUSIONS: The present findings suggest that clinical triage is safely assisted by chest radiography. An integrated algorithm using first-line chest radiography and contingent use of HRCT can help optimise management and prognostication of COVID-19.

Epidemiology of SARS-CoV-2 Infection Evaluated by Immunochromatographic Rapid Testing for the Determination of IgM and IgG Against SARS-CoV-2 in a Cohort of Mask Wearing Workers in the Metal-Mechanical Sector in an Area With a High Incidence of COVID-19.

Background: Although the diagnosis of new coronavirus 2019 (COVID-19) is made through the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory secretions by means of molecular methods, a more accurate estimation of SARS-CoV-2 circulation can be obtained by seroprevalence studies. The main aim of this study was to evaluate the true epidemiology of SARS-CoV-2 infection among workers in the metal-mechanical sector who never stopped working during the pandemic period in an area with a high incidence of COVID-19 and to define whether and how they could continue the work without appreciable risks during a second wave. Methods: A total of 815 metal-mechanical workers who had never stopped working even during the pandemic period in three different factories in the Emilia-Romagna Region, Italy, and who had always used face masks during working hours, underwent a capillary blood rapid test for the determination of IgM and IgG against SARS-CoV-2 (COVID-19 IgG/IgM Rapid test, PrimaLab, Modena, Italy). In the event of a positive test, a nasopharyngeal was performed and tested for the presence of SARS-CoV-2. Results: The detection of serum IgG/IgM against SARS-CoV-2 was significantly more common among workers employed in Parma (21/345, 6.1%) than among those employed in Calerno (7/242, 2.9%) or in Spilamberto (3/228, 1.3%) (p <0.001). The analysis of the role of the different variables as predictors of seropositivity for IgG/IgM against SARS-CoV-2 revealed that the presence of specific antibodies was strictly associated with a previous history of COVID-19-like symptoms (odds ratio [OR] 3.95, 95% confidence interval [CI] 1.9-8.2) and household members with COVID-19-like symptoms (OR 2.20, 95% CI 1.04-4.82). Conclusion: This study shows that seropositivity to SARS-CoV-2 is low even among employees who did not interrupt their work during the lockdown phase in a region with a high incidence of COVID-19. The use of face masks appears effective in the avoidance of the transmission of SARS-CoV-2 in factories even in the presence of asymptomatic or mildly symptomatic workers, suggesting that work activities can continue if adequate infection control measures are used during a second wave.

Frequency and characterization of ancillary chest CT findings in COVID-19 pneumonia.

OBJECTIVES: Ground-glass opacity and consolidation are recognized typical features of Coronavirus disease-19 (COVID-19) pneumonia on Chest CT, yet ancillary findings have not been fully described. We aimed to describe ancillary findings of COVID-19 pneumonia on CT, to define their prevalence, and investigate their association with clinical data. METHODS: We retrospectively reviewed our CT chest cases with coupled reverse transcriptase polymerase chain reaction (rt-PCR). Patients with negative rt-PCR or without admission chest CT were excluded. Ancillary findings included: vessel enlargement, subpleural curvilinear lines, dependent subpleural atelectasis, centrilobular solid nodules, pleural and/or pericardial effusions, enlarged mediastinal lymph nodes. Continuous data were expressed as median and 95% confidence interval (95% CI) and tested by Mann-Whitney U test. RESULTS: Ancillary findings were represented by 106/252 (42.1%, 36.1 to 48.2) vessel enlargement, 50/252 (19.8%, 15.4 to 25.2) subpleural curvilinear lines, 26/252 (10.1%, 7.1 to 14.7) dependent subpleural atelectasis, 15/252 (5.9%, 3.6 to 9.6) pleural effusion, 15/252 (5.9%, 3.6 to 9.6) mediastinal lymph nodes enlargement, 13/252 (5.2%, 3 to 8.6) centrilobular solid nodules, and 6/252 (2.4%, 1.1 to 5.1) pericardial effusion. Air space disease was more extensive in patients with vessel enlargement or centrilobular solid nodules (p < 0.001). Vessel enlargement was associated with longer history of fever (p = 0.035) and lower admission oxygen saturation (p = 0.014); dependent subpleural atelectasis with lower oxygen saturation (p < 0.001) and higher respiratory rate (p < 0.001); mediastinal lymph nodes with shorter history of cough (p = 0.046); centrilobular solid nodules with lower prevalence of cough (p = 0.023), lower oxygen saturation (p < 0.001), and higher respiratory rate (p = 0.032), and pericardial effusion with shorter history of cough (p = 0.015). Ancillary findings associated with longer hospital stay were subpleural curvilinear lines (p = 0.02), whereas centrilobular solid nodules were associated with higher rate of intensive care unit admission (p = 0.01). CONCLUSION: Typical high-resolution CT findings of COVID-19 pneumonia are frequently associated with ancillary findings that variably associate with disease extent, clinical parameters, and disease severity. ADVANCES IN KNOWLEDGE: Ancillary findings might reflect the broad range of heterogeneous mechanisms in severe acute respiratory syndrome from viral pneumonia, and potentially help disease phenotyping.

Home Management of Children With COVID-19 in the Emilia-Romagna Region, Italy.

In most children, coronavirus disease 2019 (COVID-19) is a mild or moderate disease. Moreover, in a relevant number of cases, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection remains totally asymptomatic. All these findings seem to suggest that otherwise healthy children with suspected COVID-19 might be managed in the community in most cases, thus avoiding hospital admission and closely related medical, social and economic problems, including overwhelming hospitals. Unfortunately, home management of children with suspected COVID-19 rarely occurs, and many children with suspected or laboratory-confirmed SARS-CoV-2 infection are frequently hospitalized irrespective of the severity of disease. To evaluate the role of community health houses (CHHs) in the management of children with COVID-19, 1,009 children with suspected SARS-CoV-2 infection were studied in Emilia-Romagna Region, Italy. Among them, 194 (19.2%) resulted positive for SARS-CoV-2. The majority (583, 58%) were tested at home by CHHs, while 426 (42%) were brought to the hospital for testing. The patients who were managed in the hospital had a significantly lower median age than those who were managed at home (2 vs. 12 years, p < 0.001). Exposure to SARS-CoV-2 cases within the family was significantly more frequent among those who were managed at home (82 vs. 46%, p < 0.05). The clinical findings were similar between the children who were managed at home and those who were managed in the hospital. Only one of the children managed at home (0.7%) required hospitalization; in comparison, 26 (48%) of those whose swab samples were taken at the hospital were hospitalized. Our research shows for the first time the importance of CHHs in the management of COVID-19 in children; because of the high frequency of mild to moderate cases, management by CHHs can reduce the care load in hospitals, providing enormous advantages on the familial, medical, social, and economic levels. These findings could be useful for suggesting a territorial rather than hospital-based strategy in pediatrics in the case of a new wave of the epidemic.

Vaccine hesitancy in COVID-19 times. An update from Italy before flu season starts.

The COVID-19 pandemic and response caused a worrying decline in vaccine uptake around the world. In Italy, the immunization coverage targets set in the 2017-19 National Immunization Prevention Plan (PNPV) have been met only partially. The current public health emergency is likely to have negatively impacted on immunization , with the risk of re-occurrence of Vaccine-Preventable Diseases (VPDs) outbreaks. As flu season approaches, both National Health Institutions  and the scientific community in Italy have taken action. Well in advance as compared to previous years, the Ministry of Health released  the Circular to launch the 2020-2021 influenza immunization campaign which this year is longer (starting on October 2020) and extends flu vaccine recommendations to more  "at risk" subgroups, offered the vaccine free of charge. In addition, some Italian Regions have recently tried to make  flu vaccination compulsory for all Healthcare Workers (HCWs). Since 2017, when the law on childhood vaccination in Italy was passed, compulsory vaccination has proved to be a successful strategy towards coverage increase.

Therapeutic strategies against COVID-19.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that mainly affects the upper and lower respiratory tract and is responsible for extremely different degrees of disease, ranging from flu-like symptoms to atypical pneumonia that may evolve to acute respiratory distress syndrome and, ultimately, death. No specific therapy for SARS-CoV-2 has yet been identified, but since the beginning of the outbreak, several pre-existing therapeutics have been reconsidered for the treatment of infected patients. The aim of this article is to discuss current therapeutics against SARS-CoV-2. A literature review was performed using PubMed, collecting data from English-language articles published until June 20th, 2020. Literature analysis showed that with the acquisition of more in-depth knowledge on the characteristics of SARS-CoV-2 and the pathogenesis of the different clinical manifestations, a more rationale use of available drugs has become possible. However, the road to defining which drugs are effective and which schedules of administration must be used to maximize efficacy and minimize adverse events is still very long. To date, it is only clear that no drug can alone cope with all the problems posed by SARS-CoV-2 infection and effective antivirals and inflammatory drugs must be given together to reduce COVID-19 clinical manifestations. Moreover, choice of therapy must always be tailored on clinical manifestations and, when they occur, drugs able to fight coagulopathy and venous thromboembolism that may contribute to respiratory deterioration must be prescribed.

Virological surveillance of SARS-CoV-2 in an Italian northern area: comparison of Real Time RT PCR cycle threshold (Ct) values in three epidemic periods.

Aim of the study was to investigate the differences in Ct values in nasopharingeal swabs collected in three SARS-CoV-2 epidemic periods: first one from February 23 to March 25 (14 days from lockdown started on March 11); the second one from  March  26 to May 18 (14 days  from the end of strict lockdown on May 4) and the third one from May 19 until June 15. Viral RNA was detected in nasopharyngeal swabs obtained both from inpatients and outpatients. COVID-19 infection was confirmed according to the Ct values for N1 and N2 genes ascertained by Real-Time RT-PCR assay as described by the CDC. We calculated the prevalence of nasopharyngeal swabs tested positive for SARS-CoV-2, the mean and median of the Cts and the percentage of samples equal or below the Ct value of 25 in the 3 periods considered. The average value of Ct increased, going from 24.80 in the first epidemic period to 26.64 in the second period to 28.50 in the third period (p <0.001). The percentage of samples with Ct lower than or equal to 25 also decreased sharply from 54.7% to 20.0%. These findings need to be integrated with epidemiological and clinical data.

Detection of SARS-CoV-2 on hospital surfaces.

The COVID-19 pandemic, affecting 213 countries, with more than 10 million cases and over 500,000 deaths is still causing serious health, social and economic emergency worldwide. Italian Northern regions are among the most badly affected areas. Surfaces represent matrices to which particular attention should be paid for prevention and control of SARS-CoV-2 transmission. A few studies have highlighted virus presence on surfaces. We report the evidence of its presence on hospital surfaces, in a single room hosting a patient whose nose-pharyngeal swab resulted positive for SARS-CoV-2 RNA at the admission. The surfaces sampling was carried out using pre-wetted swabs followed by extraction and amplification of viral RNA by reverse Real-Time Polymerase Chain Reaction (rRT-PCR). A total of 4/15 (26.66%) surfaces were positive for SARS-CoV-2 RNA: the right bed rail, the call button, the bed trapeze bar, the stethoscope; moreover, the patient's inner surgical mask was positive, showing the emission of the virus from the patient. This study is a further confirmation that the surfaces represent a potential vehicle of transmission. This supports the need for strict adherence to hand and environmental hygiene.

Vaccines against Coronaviruses: The State of the Art.

The emerging epidemic caused by the new coronavirus SARS-CoV-2 represents the most important socio-health threat of the 21st century. The high contagiousness of the virus, the strong impact on the health system of the various countries and the absence to date of treatments able to improve the prognosis of the disease make the introduction of a vaccine indispensable, even though there are currently no approved human coronavirus vaccines. The aim of the study is to carry out a review of the medical literature concerning vaccine candidates for the main coronaviruses responsible for human epidemics, including recent advances in the development of a vaccine against COVID-19. This extensive review carried out on the vaccine candidates of the main epidemic coronaviruses of the past has shown that the studies in animal models suggest a high efficacy of potential vaccines in providing protection against viral challenges. Similar human studies have not yet been carried out, as the main trials are aimed at assessing mainly vaccine safety and immunogenicity. Whereas the severe acute respiratory syndrome (SARS-CoV) epidemic ended almost two decades ago and the Middle East respiratory syndrome (MERS-CoV) epidemic is now better controlled, as it is less contagious due to the high lethality of the virus, the current SARS-CoV-2 pandemic represents a problem that is certainly more compelling, which pushes us to accelerate the studies not only for the production of vaccines but also for innovative pharmacological treatments. SARS-CoV-2 vaccines might come too late to affect the first wave of this pandemic, but they might be useful if additional subsequent waves occur or in a post-pandemic perspective in which the virus continues to circulate as a seasonal virus.