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Background: The novel coronavirus disease is an ongoing pandemic that started in China in December 2019. This paper is aimed at estimating the first two infections waves in Italy in relation to adopted health policies. Design and methods: We moved deaths of the Italian COVID-19 registry from recorded to infection date by the weighted moving average. We considered two infection fatality ratios related to the effective or saturated health system, we estimated the likely incidence curve from the resulting deaths and evaluated the curve shape before and after the national health policies. Results: From the 24th of February 2020 to the 7th of February 2021, we estimated 6,664,655 (4,639,221-9,325,138) cases distributed on two waves. Suitable daily infection fatality rates were 2.53% within the first wave and 1.15% within the second one. The first wave (February-July 2020) had its peak on the 14th of March 2020 (26,575). The second wave (August 2020-February 2021) was fatter with the peak on the 12th of November (60,425) and a hump in December before decreasing to 26,288 at the end. Adopted health policies were followed by changes in the curve rate. Conclusions: Tracing infection contacts and quarantining asymptomatic people reduced virus lethality in the second wave. Restriction on population mobility is effective within a suppression strategy, distance learning reduces contacts among families. Removal of restrictions should be implemented by sequential steps for avoiding a quick rising of incident cases. A reasonable public health daily goal to control both virus spread and lethality could be to find at least 87 cases for each death. [ABSTRACT FROM AUTHOR]

COVID-19 is a major global health threat, with millions of confirmed cases and deaths worldwide. Containment and mitigation strategies, including vaccination, have been implemented to reduce transmission and protect the population. We conducted two systematic reviews to collect nonrandomized studies investigating the effects of vaccination on COVID-19-related complications and deaths in the Italian population. We considered studies conducted in Italian settings and written in English that contained data on the effects of vaccination on COVID-19-related mortality and complications. We excluded studies that pertained to the pediatric population. In total, we included 10 unique studies in our two systematic reviews. The results showed that fully vaccinated individuals had a lower risk of death, severe symptoms, and hospitalization compared to unvaccinated individuals. The review also looked at the impact of vaccination on post-COVID-19 syndrome, the effectiveness of booster doses in older individuals, and nationwide adverse events. Our work highlights the crucial role that vaccination campaigns have played in reducing the burden of COVID-19 disease in the Italian adult population, positively impacting the pandemic trajectory in Italy. [ABSTRACT FROM AUTHOR]

At the very beginning of the European spread of SARS-CoV-2, Piedmont was one of the most affected regions in Italy, with a strong impact on healthcare organizations. In this study, we evaluated the characteristics and outcomes of the COVID-19 patients in an entire region during the first three pandemic waves, identifying similarities and differences in the SARS-CoV-2 epidemic's timeline. We collected the health-administrative data of all the Piedmont COVID-19 patients infected during the first three pandemic waves (1 March 2020–15 April 2020; 15 October 2020–15 December 2020; 1 March 2021–15 April 2021, respectively). We compared differences among the waves in subjects positive for SARS-CoV-2 and in patients admitted to ICU. Overall, 18.621 subjects tested positive during the first wave (405 patients/day), 144.350 (2366.4 patients/day) in the second, and 81.823 (1778.8 patients/day) in the third. In the second and third waves, we observed a reduction in median age, comorbidity burden, mortality in outpatients, inpatients, and patients admitted to ICU, in intubation, invasive ventilation and tracheostomy, and a parallel increase in the use of CPAP. Our study confirmed a trend towards younger and healthier patients over time but also showed an independent effect of the period on mortality and ICU admission. The appearance of new viral variants, the starting of vaccination, and organizational improvements in tracking, outpatients and inpatients management could have influenced these trends. [ABSTRACT FROM AUTHOR]

In Winter 2020, Italy, and in particular the Lombardy region, was the first country in the Western hemisphere to be hit by the COVID-19 pandemic. Plasma from individuals recovered from COVID-19 (COVID-19 convalescent plasma, CCP) was the first therapeutic tool adopted to counteract the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). In this retrospective cohort study, we report the experience of the city hospital of Mantua, Lombardy region, on the compassionate use of CCP in patients hospitalized for severe COVID-19. Between April 2020 and April 2021, 405 consecutive COVID-19 patients received 657 CCP units with a median anti-SARS-CoV-2 neutralizing antibody (nAb) titer of 160 (interquartile range (IQR), 80–320). Their median age was 68 years (IQR, 56–78 years), and 62% were males. At enrollment, 55% of patients had an increased body mass index (BMI), and 25.6% had at least three comorbidities. The 28-day crude mortality rate was 12.6% (51/405). Young age (<68 years), mild disease (admission to low-intensity departments) and early treatment (<7 days from symptoms onset) with high nAb titer (≥320) CCP were found as independently associated with a favorable response to CCP treatment. No safety concerns were recorded, with a rate of CCP-related adverse reactions (all of mild intensity) of 1.3%. In our real-life experience, the first in the western world, early administration of high-titer CCP was a safe and effective treatment for hospitalized COVID-19 patients. [ABSTRACT FROM AUTHOR]

Background: Italy has been the first European country to be affected by the COVID-19 epidemic which started out at the end of February. In this report, we focus our attention on the Veneto Region, in the North-East of Italy, which is one of the areas that were first affected by the rapid spread of SARS-CoV-2. We aim to evaluate the trend of all-cause mortality and to give a description of the characteristics of the studied population.Methods: Data used in the analyses were released by the majority of municipalities and cover the 93% of the total population living in the Veneto Region. We evaluated the trend of overall mortality from Jan.01 to Jun.30. 2020. Moreover we compared the COVID-19-related deaths to the overall deaths.Results: From March 2020, the overall mortality rate increased exponentially, affecting males and people aged > 76 the most. The confirmed COVID-19-related death rate in the Veneto region between Mar.01 and Apr.302020 is 30 per 100,000 inhabitants. In contrast, the all-cause mortality increase registered in the same months in the municipalities included in the study is 219 per 100,000 inhabitants.Conclusions: COVID-19 has a primary role in the increase in mortality but does not entirely explain such a high number of deaths. Strategies need to be developed to reduce this gap in case of future waves of the pandemic. [ABSTRACT FROM AUTHOR]

Background: CORACLE is a retrospective and prospective, regional multicenter registry, developed to evaluate risk factors for mortality in a cohort of patients admitted with SARS-CoV-2 infection within non-intensive wards. Methods: The primary objective was to estimate the role of several prognostic factors on hospital mortality in terms of adjusted Odds Ratios (aOR) with multivariable logistic regression models. Results: A total of 1538 patients were enrolled; 42% were female, and 58% were >70 years old. Deceased patients were 422 (27%), with a median age of 83 years (IQR (Inter Quartile Range) 76–87). Older age at admission (aOR 1.07 per year, 95%CI 1.06–1.09), diabetes (1.41, 1.02–1.94), cardiovascular disease (1.79, 1.31–2.44), immunosuppression (1.65, 1.04–2.62), estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (3.53, 2.26–5.51), higher C-reactive protein values and a decreased PaO2/FiO2 ratio at admission were associated with a higher risk of hospital mortality. Amongst patients still alive on day 7, only hydroxychloroquine (HCQ) treatment was associated with reduced mortality (0.57, 0.36–0.90). Conclusions: Several risk factors were associated with mortality in SARS-CoV-2 positive patients. Although HCQ seems to be the only factor significantly associated with reduced mortality, this result is in contrast with evidence from randomized studies. These results should be interpreted in light of the study limitations. [ABSTRACT FROM AUTHOR]

Background: Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. We have identified IFNβ-1a as the most promising drug to be repurposed for COVID-19. The rationale relies on the evidence of IFNβ anti-viral activity in vitro against SARS-CoV-2 and animal models resembling SARS-CoV-2 infection and on a recent clinical trial where IFNβ was indicated as the key component of a successful therapeutic combination.Methods: This is a randomized, controlled, open-label, monocentric, phase II trial (INTERCOP trial). One hundred twenty-six patients with positive swab detection of SARS-CoV-2, radiological signs of pneumonia, and mild-to-moderate disease will be randomized 2:1 to IFNβ-1a in addition to standard of care vs standard of care alone. No other anti-viral drugs will be used as part of the regimens, both in the control and the intervention arms. IFNβ-1a will be administered subcutaneously at the dose of 44 mcg (equivalent to 12 million international units) three times per week, at least 48 h apart, for a total of 2 weeks. The primary outcome is the time to negative conversion of SARS-CoV-2 nasopharyngeal swabs. Secondary outcomes include improvement or worsening in a clinical severity score measured on a 7-point ordinal scale (including transfer to intensive care unit and death), oxygen- and ventilator-free days, mortality, changes in pulmonary computed tomography severity score, hospital stay duration, reduction of viral load measured on nasopharyngeal swabs, number of serious adverse events, and changes in biochemical markers of organ dysfunction. Exploratory outcomes include blood cell counts, cytokine and inflammatory profile, peripheral mRNA expression profiles of interferon-stimulated genes, and antibodies to SARS-CoV-2 and to IFNβ-1a. INTERCOP is the first study to specifically investigate the clinical benefits of IFNβ-1a in COVID-19 patients.Discussion: Potential implications of this trial are multifaceted: should the primary outcome be fulfilled and the treatment be safe, one may envisage that IFNβ-1a be used to reduce the infectivity of patients with mild-to moderate disease. In case IFNβ-1a reduced the duration of hospital stay and/or ameliorated the clinical status, it may become a cornerstone of COVID-19 treatment.Trial Registration: EudraCT 2020-002458-25. Registered on May 11, 2020 ClinicalTrials.gov Identifier: NCT04449380. [ABSTRACT FROM AUTHOR]