Special Issue "Pandemic Outbreak of Coronavirus"

A special issue of Medicina (ISSN 1648-9144). This special issue belongs to the section "Infectious Disease".

Deadline for manuscript submissions: closed (30 June 2021).

Special Issue Editor

Prof. Dr. Stefano Aquaro
E-Mail Website
Guest Editor
Department of Pharmacy, Health, and Nutritional Sciences, University of Calabria, Rende, Italy
Interests: virus evolution; macrophages; HIV pathogenesis; antivirals; HIV chemotherapy; neuroAIDS; mechanisms of virus entry; chemokines and chemokine receptors; role of astrocytes and neurones in HIV infection
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Special Issue Information

Dear Colleagues,

Chinese health authorities reported a cluster of pneumonia cases of unknown aetiology in the city of Wuhan, Hubei province in December 2019. The WHO declared the international SARS-CoV-2 outbreak a Public Health Emergency of International Concern. It is necessary to better characterize the virus in terms of structure, life cycle, tropism, genetic evolution, pathogenetic mechanisms, and associated pathologies. At the same time, it seems necessary to develop novel therapeutic approaches and rationale, and possibly antiviral compounds and vaccines. All researchers working in the fields of human viral infections and antiviral drugs are cordially invited to contribute original research papers or reviews to this Special Issue of Medicina.

Prof. Dr. Stefano Aquaro
Guest Editor

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Keywords

  • SARS-CoV-2
  • COVID-19
  • Antivirals against SARS-CoV-2
  • Vaccines against SARS-CoV

Published Papers (12 papers)

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Research

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Article
Characteristics, Management, and Outcomes of Elderly Patients with Diabetes in a Covid-19 Unit: Lessons Learned from a Pilot Study
Medicina 2021, 57(4), 341; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57040341 - 01 Apr 2021
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Abstract
Background and objectives: Diabetes may affect in-hospital mortality of patients with Coronavirus disease 2019 (COVID-19). We have retrospectively evaluated clinical characteristics, diabetes management, and outcomes in a sample of COVID-19 patients with diabetes admitted to our hospital. Materials and Methods: All [...] Read more.
Background and objectives: Diabetes may affect in-hospital mortality of patients with Coronavirus disease 2019 (COVID-19). We have retrospectively evaluated clinical characteristics, diabetes management, and outcomes in a sample of COVID-19 patients with diabetes admitted to our hospital. Materials and Methods: All patients admitted to the Infectious Diseases Unit from 28 March 2020, to 16 June 2020, were enrolled. Clinical information and biochemical parameters were collected at the time of admission. Patients were ranked according to diabetes and death. Results: Sixty-one patients with COVID-19 were analyzed. Most of them were from a long-term health care facility. Mean age was 77 ± 16 years, and 19 had type 2 diabetes (T2D). Eighteen patients died, including 8 with T2D and 10 without T2D (p = 0.15). Patients with diabetes were significantly older, had a higher prevalence of cardiovascular diseases, and a significantly lower lymphocyte count. No significant relationship was found between diabetes and in-hospital mortality (Odds Ratio OR 2.3; Confidence Interval CI 0.73–7.38, p = 0.15). Patients with diabetes were treated with insulin titration algorithm. Severe hypoglycemic events, ketoacidosis and hyperosmolar hyperglycemias did not occur during hospitalization. Mean pre-meal capillary blood glucose was 157 ± 45 mg/dL, and the coefficient of variation of glycaemia was 29%. Conclusions: Our study, albeit limited by the small number of subjects, did not describe any significant association between T2D diabetes and mortality. Clinical characteristics of patients, and acceptable glucose control prior and during hospitalization may have influenced the result. The use of an insulin titration algorithm should be pursued during hospitalization. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Article
The Spread of the COVID-19 Outbreak in Brazil: An Overview by Kohonen Self-Organizing Map Networks
Medicina 2021, 57(3), 235; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57030235 - 03 Mar 2021
Cited by 4 | Viewed by 822
Abstract
Background and objective: In the current pandemic scenario, data mining tools are fundamental to evaluate the measures adopted to contain the spread of COVID-19. In this study, unsupervised neural networks of the Self-Organizing Maps (SOM) type were used to assess the spatial [...] Read more.
Background and objective: In the current pandemic scenario, data mining tools are fundamental to evaluate the measures adopted to contain the spread of COVID-19. In this study, unsupervised neural networks of the Self-Organizing Maps (SOM) type were used to assess the spatial and temporal spread of COVID-19 in Brazil, according to the number of cases and deaths in regions, states, and cities. Materials and methods: The SOM applied in this context does not evaluate which measures applied have helped contain the spread of the disease, but these datasets represent the repercussions of the country’s measures, which were implemented to contain the virus’ spread. Results: This approach demonstrated that the spread of the disease in Brazil does not have a standard behavior, changing according to the region, state, or city. The analyses showed that cities and states in the north and northeast regions of the country were the most affected by the disease, with the highest number of cases and deaths registered per 100,000 inhabitants. Conclusions: The SOM clustering was able to spatially group cities, states, and regions according to their coronavirus cases, with similar behavior. Thus, it is possible to benefit from the use of similar strategies to deal with the virus’ spread in these cities, states, and regions. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Article
Estimation of the Number of General Anesthesia Cases Based on a Series of Nationwide Surveys on Twitter during COVID-19 Pandemic in Japan: A Statistical Analysis
Medicina 2021, 57(2), 153; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57020153 - 08 Feb 2021
Cited by 1 | Viewed by 678
Abstract
Background and objectives: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread to more than 200 countries. In light of this situation, the Japanese Government declared a state of emergency in seven regions of Japan on 7 [...] Read more.
Background and objectives: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread to more than 200 countries. In light of this situation, the Japanese Government declared a state of emergency in seven regions of Japan on 7 April 2020 under the provisions of the law. The medical care delivery system has been under pressure. Although various surgical societies have published guidelines on which to base their surgical decisions, it is not clear how general anesthesia has been performed and will be performed in Japan. Materials and Methods: One of the services provided by the social network service Twitter is a voting function—Twitter Polls—through which anonymous surveys were conducted. We analyzed the results of a series of surveys 17 times over 22 weeks on Twitter on the status of operating restrictions using quadratic programming to solve the mathematical optimizing problem, and public data provided by the Japanese Government were used to estimate the current changes in the number of general anesthesia performed in Japan. Results: The minimum number of general anesthesia cases per week was estimated at 67.1% compared to 2015 on 27 April 2020. The timeseries trend was compatible with the results reported by the Japanese Society of Anesthesiologists (correlation coefficient r = 0.69, p < 0.001). Conclusions: The number of general anesthesia was reduced up to two-thirds during the pandemic of COVID-19 in Japan and was successfully quantitatively estimated using a quick questionnaire on Twitter. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Article
Physical Activity Levels and Mental Health during the COVID-19 Pandemic: Preliminary Results of a Comparative Study between Convenience Samples from Brazil and Switzerland
Medicina 2021, 57(1), 48; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57010048 - 08 Jan 2021
Cited by 5 | Viewed by 1103
Abstract
Background and objectives: It has been suggested that the COVID-19 pandemic impaired people’s moods and general levels of physical activity, but the way in which each country is coping with the situation may result in different outcomes. The aim of the present study [...] Read more.
Background and objectives: It has been suggested that the COVID-19 pandemic impaired people’s moods and general levels of physical activity, but the way in which each country is coping with the situation may result in different outcomes. The aim of the present study was to compare the mental health and physical activity levels between residents of Brazil and Switzerland during the social distancing period associated with COVID-19 pandemic. Materials and Methods: A self-administered questionnaire aiming to assess personal, quarantine, physical activity, and mood state disorders data was answered by 114 participants (57 from each country) of both sexes. Results: Swiss participants presented a higher frequency of people (47.4%) not abiding by social distancing measures compared to Brazilian participants (1.8%; p < 0.001, effect size = 0.56). There were no significant differences between the participants from the two countries regarding physical activity levels (p = 0.09). The Swiss presented a higher frequency (78.9%) of people without symptoms of depression compared to Brazilians (31.6%; p < 0.001, effect size = 0.48). The Swiss also presented a higher frequency (77.2%) of people without symptoms of anxiety compared to Brazilians (35.1%; p < 0.001, effect size = 0.43). There was a significant association between the restriction level and depression symptoms (p = 0.01, effect size = 0.25) but not with anxiety symptoms (p = 0.21, effect size = 0.16). Conclusions: According to the preliminary results, Brazilians presented a much higher frequency of depression and anxiety symptoms, which can be explained by characteristics other than the restriction level. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
Article
Critical Care Demand and Intensive Care Supply for Patients in Japan with COVID-19 at the Time of the State of Emergency Declaration in April 2020: A Descriptive Analysis
Medicina 2020, 56(10), 530; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina56100530 - 12 Oct 2020
Cited by 2 | Viewed by 899
Abstract
Background and objectives: The coronavirus disease 2019 (COVID-19) pandemic is overwhelming Japan’s intensive care capacity. This study aimed to determine the number of patients with COVID-19 who required intensive care and to compare the numbers with Japan’s intensive care capacity. Materials and Methods: [...] Read more.
Background and objectives: The coronavirus disease 2019 (COVID-19) pandemic is overwhelming Japan’s intensive care capacity. This study aimed to determine the number of patients with COVID-19 who required intensive care and to compare the numbers with Japan’s intensive care capacity. Materials and Methods: Publicly available datasets were used to obtain the number of confirmed patients with COVID-19 undergoing mechanical ventilation and extracorporeal membrane oxygenation (ECMO) between 15 February and 19 July 2020 to determine and compare intensive care unit (ICU) and attending bed needs for patients with COVID-19, and to estimate peak ICU demands in Japan. Results: During the epidemic peak in late April, 11,443 patients (1.03/10,000 adults) had been infected, 373 patients (0.034/10,000 adults) were in ICU, 312 patients (0.028/10,000 adults) were receiving mechanical ventilation, and 62 patients (0.0056/10,000 adults) were under ECMO per day. At the peak of the epidemic, the number of infected patients was 651% of designated beds, and the number of patients requiring intensive care was 6.0% of ICU beds, 19.1% of board-certified intensivists, and 106% of designated medical institutions in Japan. Conclusions: The number of critically ill patients with COVID-19 continued to rise during the pandemic, exceeding the number of designated beds but not exceeding ICU capacity. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Review

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Review
Mitochondria and Mitochondrial DNA: Key Elements in the Pathogenesis and Exacerbation of the Inflammatory State Caused by COVID-19
Medicina 2021, 57(9), 928; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57090928 - 03 Sep 2021
Viewed by 577
Abstract
Background and Objectives. The importance of mitochondria in inflammatory pathologies, besides providing energy, is associated with the release of mitochondrial damage products, such as mitochondrial DNA (mt-DNA), which may perpetuate inflammation. In this review, we aimed to show the importance of mitochondria, [...] Read more.
Background and Objectives. The importance of mitochondria in inflammatory pathologies, besides providing energy, is associated with the release of mitochondrial damage products, such as mitochondrial DNA (mt-DNA), which may perpetuate inflammation. In this review, we aimed to show the importance of mitochondria, as organelles that produce energy and intervene in multiple pathologies, focusing mainly in COVID-19 and using multiple molecular mechanisms that allow for the replication and maintenance of the viral genome, leading to the exacerbation and spread of the inflammatory response. The evidence suggests that mitochondria are implicated in the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which forms double-membrane vesicles and evades detection by the cell defense system. These mitochondrion-hijacking vesicles damage the integrity of the mitochondrion’s membrane, releasing mt-DNA into circulation and triggering the activation of innate immunity, which may contribute to an exacerbation of the pro-inflammatory state. Conclusions. While mitochondrial dysfunction in COVID-19 continues to be studied, the use of mt-DNA as an indicator of prognosis and severity is a potential area yet to be explored. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Review
NOX2 Activation in COVID-19: Possible Implications for Neurodegenerative Diseases
Medicina 2021, 57(6), 604; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57060604 - 11 Jun 2021
Viewed by 859
Abstract
Coronavirus disease 2019 (COVID-19) is a rapidly spreading contagious infectious disease caused by the pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that primarily affects the respiratory tract as well as the central nervous system (CNS). SARS-CoV-2 infection occurs through the interaction of [...] Read more.
Coronavirus disease 2019 (COVID-19) is a rapidly spreading contagious infectious disease caused by the pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that primarily affects the respiratory tract as well as the central nervous system (CNS). SARS-CoV-2 infection occurs through the interaction of the viral protein Spike with the angiotensin II receptor (ACE 2), leading to an increase of angiotensin II and activation of nicotinamide adenine dinucleotide phosphate oxidase2 (NOX2), resulting in the release of both reactive oxygen species (ROS) and inflammatory molecules. The purpose of the review is to explain that SARS-CoV-2 infection can determine neuroinflammation that induces NOX2 activation in microglia. To better understand the role of NOX2 in inflammation, an overview of its involvement in neurodegenerative diseases (NDs) such as Parkinson’s disease (PD), Alzheimer’s disease (AD), and amyotrophic lateral sclerosis (ALS) is provided. To write this manuscript, we performed a PubMed search to evaluate the possible relationship of SARS-CoV-2 infection in NOX2 activation in microglia, as well as the role of NOX2 in NDs. Several studies highlighted that NOX2 activation in microglia amplifies neuroinflammation. To date, there is no clinical treatment capable of counteracting its activation, however, NOX2 could be a promising pharmaceutical target useful for both the treatment and prevention of NDs and COVID-19 treatment. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
Review
Saliva: What Dental Practitioners Should Know about the Role of This Biofluid in the Transmission and Diagnostic of SARS-CoV-2
Medicina 2021, 57(4), 349; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57040349 - 06 Apr 2021
Viewed by 1136
Abstract
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak has become a global ongoing pandemic. This pandemic represents a great work risk for all health professionals, it includes dental professionals who are in constant contact with saliva, which represents one of the [...] Read more.
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak has become a global ongoing pandemic. This pandemic represents a great work risk for all health professionals, it includes dental professionals who are in constant contact with saliva, which represents one of the main routes of transmission of the disease. This is due to the fact that a wide variety of oral tissues and cells are susceptible to infection by SARS-CoV-2 and that they express the ACE2 receptor, which is the main route of entry of the virus into cells, as well as the proteins TMPRSS and furin that contributes to the binding of the virus to the host cells. According to recent studies, some of the oral cells most susceptible to infection by SARS-CoV-2 are the epithelial cells of the salivary glands. This explains the presence of the virus in the saliva of infected patients and provides scientific evidence that supports the use of saliva as a biofluid that offers the opportunity to develop new detection and diagnostic techniques. This is because saliva is much easier to collect compared to nasopharyngeal swab. However, the presence of the virus in saliva, also represents a great source of transmission, since the main form of infection is through microscopic drops that are generated when infected people cough or sneeze. Likewise, health professionals, such as dentists are exposed to contagion through saliva. The objective of this review article is to provide a perspective on the main cells and tissues that can be affected by the virus, the risk of contagion that the presence of the virus in saliva represents for dentists; and the new techniques developed from saliva samples for the diagnosis and surveillance of SARS-CoV-2 infection. This review is expected to contribute to the knowledge of oral health professionals about the risk of saliva in the spread of SARS-CoV-2, but also its advantages as a diagnostic tool for pandemic control. In conclusion, the authors can mention that information that provides more scientific evidence of the mechanisms of infection of the coronavirus in oral cells and tissues is being published continually. This also explains the presence of the virus in the saliva of infected people and the risk of contagion that this means. It also provides scientific evidence of the use of saliva as a biofluid for the detection, diagnosis, monitoring, and control of the spread of the virus. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)

Other

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Case Report
A Case of COVID-19 Pregnancy Complicated with Hydrops Fetalis and Intrauterine Death
Medicina 2021, 57(7), 667; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57070667 - 28 Jun 2021
Cited by 1 | Viewed by 1139
Abstract
Coronavirus disease 2019 (COVID-19) has rapidly evolved into a worldwide pandemic causing a serious global public health problem. The risk of vertical transmission of SARS-CoV-2 is still debated, and the consequences of this virus on pregnant women and their fetuses remain unknown. We [...] Read more.
Coronavirus disease 2019 (COVID-19) has rapidly evolved into a worldwide pandemic causing a serious global public health problem. The risk of vertical transmission of SARS-CoV-2 is still debated, and the consequences of this virus on pregnant women and their fetuses remain unknown. We report a case of pregnancy complicated with hydrops fetalis that developed 7 weeks after recovery from a mild SARS-CoV-2 infection, leading to intrauterine death of the foetus. Evidence of SARS-CoV-2 placentitis was demonstrated by the presence of viral particles in the placenta identified by immunohistochemistry. As we excluded all possible etiological factors for non-immunologic hydrops fetalis, we believe that the fetal consequences of our case are related to vertical transmission of SARS-CoV-2 virus. To the best of our knowledge, this is the second reported case in the literature of COVID-19 infection complicated with hydrops fetalis and intrauterine fetal demise. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Systematic Review
Presence of SARS-CoV-2 and Its Entry Factors in Oral Tissues and Cells: A Systematic Review
Medicina 2021, 57(6), 523; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57060523 - 23 May 2021
Viewed by 1093
Abstract
Background and Objectives: The aim of this systematic review is to summarize the current data about the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its entry factors in oral tissues and cells. Materials and Methods: This systematic review [...] Read more.
Background and Objectives: The aim of this systematic review is to summarize the current data about the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its entry factors in oral tissues and cells. Materials and Methods: This systematic review was carried out based on the Preferred Reporting Items for a Systematic Review and Meta-Analysis (PRISMA). Three databases were analyzed (Pubmed, Web of science and Scopus) by three independent researchers. From the 18 identified studies, 10 of them met the inclusion criteria. The presence of SARS-CoV-2 or its entry factors (angiotensin-converting enzyme II (ACE2), transmembrane serine proteases (TMPRSS), and furin) was analyzed in these 10 studies during the pandemic. Results: ACE2 expression was analyzed in 9 of the 10 studies. ACE2 is expressed mainly in the tongue, oral mucosa, salivary glands and epithelial cells. The expression of the TMPRSS2 gene or protein was analyzed in 6 studies. These studies reported that the expression of TMPRSS2 was mainly in the salivary glands, tongue, sulcular epithelium and oral mucosa; as well as in cells of the salivary glands (ductal, acinar and myoepithelial cells) and the tongue (the spinous-based cell layer, horny layer and the epithelial surface). Other TMPRSS were also reported. The expression of TMPRSS3, TMPRSS4, TMPRSS5, TMPRSS7 and TMPRSS11D was reported mainly in salivary glands and in epithelial-type cells. Furan expression was analyzed in three studies. The expression of furin was detected mainly in epithelial cells of the tongue. A variety of methods were used to carry out the detection of SARS-CoV-2 or its input molecules. Conclusions: These results show that SARS-CoV-2 can infect a wide variety of oral tissues and cells, and that together with the theories dedicated to explaining the oral symptoms present in SARS-CoV-2 positive patients, it provides us with a good scientific basis for understanding the virus infection in the oral cavity and its consequences. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Systematic Review
Should We Be Concerned about the Association of Diabetes Mellitus and Periodontal Disease in the Risk of Infection by SARS-CoV-2? A Systematic Review and Hypothesis
Medicina 2021, 57(5), 493; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57050493 - 13 May 2021
Viewed by 1445
Abstract
The objective of this article was to conduct a systematic review of the literature to contrast the existing evidence regarding the relationship between periodontal disease (PD) and diabetes mellitus (DM) with the possibly increased risk of SARS-CoV-2 infection, as well as to establish [...] Read more.
The objective of this article was to conduct a systematic review of the literature to contrast the existing evidence regarding the relationship between periodontal disease (PD) and diabetes mellitus (DM) with the possibly increased risk of SARS-CoV-2 infection, as well as to establish a hypothesis that explains the ways in which this interaction could take place. A literature search up from 1 January 2020 to 21 March 2021 was conducted in three electronic databases, namely, PubMed, Web of Science, and Scopus, in order to identify studies on periodontal disease alone or in conjunction with diabetes mellitus, reporting any relation with SARS-CoV-2 infection as a primary outcome. Only articles published in the English language were included. Due to the lack of studies, we decided to collect all the theoretical and clinical evidence suggesting a possible biological pathway evidencing the relationship among PD, DM, and SARS-CoV-2 infection. From a total of 29 articles, 12 were included for final review studies (five reviews, two hypotheses, one Special Issue, one perspective, one commentary, one case–control study, and one case report). In addition, this systematic review article hypothesizes the correlation between PD and type 2 diabetes mellitus (T2DM) by expression of angiotensin-converting enzyme 2 (ACE2) in periodontal tissue and the risk of SARS-CoV-2 infection. T2DM is a metabolic disorder characterized by high blood glucose levels resulting from altered insulin secretion or action. Likewise, periodontitis and T2DM are inflammatory disorders with a bidirectional association, and both diseases have a similar immunomodulatory cascade and cytokine profile. ACE2 is a crucial component of the renin–angiotensin system (RAS) and the key factor of entry in the cells by the new SARS-CoV-2. ACE2 is widely distributed in the lung and kidneys, and interestingly has a great distribution in the oral cavity, principally in the tongue and periodontal tissue. ACE2 in periodontal tissue plays a crucial role between health and disease. Moreover, the ACE2/Ang-(1-7)/MasR axis is downregulated in the dysbiotic and inflammatory periodontal environment. Nevertheless, the balance of ACE2 activity is modified in the context of concurrent diabetes, increasing the expression of ACE2 by the uncontrolled glycemia chronic in T2DM. Therefore, the uncontrolled hyperglycemia possibly increases the risk of developing periodontitis and triggering overexpression of ACE2 in periodontal tissue of T2DM patients, with these events potentially being essential to SARS-CoV-2 infection and the development of mild-to-severe form of COVID-19. In this sense, we would like to point out that the need for randomized controlled trials is imperative to support this association. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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Perspective
Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials
Medicina 2021, 57(3), 199; https://0-doi-org.brum.beds.ac.uk/10.3390/medicina57030199 - 26 Feb 2021
Cited by 3 | Viewed by 48456
Abstract
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that [...] Read more.
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy. Full article
(This article belongs to the Special Issue Pandemic Outbreak of Coronavirus)
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