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Protective Effect of Vitamin D Supplementation on COVID-19-Related Intensive Care Hospitalization and Mortality: Definitive Evidence from Meta-Analysis and Trial Sequential Analysis
Protective Effect of Vitamin D Supplementation on COVID-19-Related Intensive Care Hospitalization and Mortality: Definitive Evidence from Meta-Analysis and Trial Sequential Analysis
The COVID-19 pandemic represents one of the world’s most important challenges for global public healthcare. Various studies have found an association between severe vitamin D deficiency and COVID-19-related outcomes. Vitamin D plays a crucial role in immune function and inflammation. Recent data have suggested a protective role of vitamin D in COVID-19-related health outcomes. The purpose of this meta-analysis and trial sequential analysis (TSA) was to better explain the strength of the association between the protective role of vitamin D supplementation and the risk of mortality and admission to intensive care units (ICUs) in patients with COVID-19. Methods: We searched four databases on 20 September 2022. Two reviewers screened the randomized clinical trials (RCTs) and assessed the risk of bias, independently and in duplicate. The pre-specified outcomes of interest were mortality and ICU admission. Results: We identified 78 bibliographic citations. After the reviewers’ screening, only five RCTs were found to be suitable for our analysis. We performed meta-analyses and then TSAs. Vitamin D administration results in a decreased risk of death and ICU admission (standardized mean difference (95% CI): 0.49 (0.34–0.72) and 0.28 (0.20–0.39), respectively). The TSA of the protective role of vitamin D and ICU admission showed that, since the pooling of the studies reached a definite sample size, the positive association is conclusive. The TSA of the protective role of vitamin D in mortality risk showed that the z-curve was inside the alpha boundaries, indicating that the positive results need further studies. Discussion: The results of the meta-analyses and respective TSAs suggest a definitive association between the protective role of vitamin D and ICU hospitalization.
4. ConclusionsThe current evidence supports the benefits of vitamin D interventions in patients hospitalized with COVID-19 due to the protective effect provided by vitamin D against ICU admission and mortality. A meta-analysis per se does not allow us to state whether the results are truly positive or false-positive. In addition, the inclusion of studies with large effect sizes and significant heterogeneity separates us from the truth. For this reason, a TSA is mandatory to verify the reliability of meta-analysis results [92]. In conclusion, the positive results highlighted again and now validated by TSAs suggest that an indisputable association between vitamin D supplementation and the protective effect on ICU admission can be considered definitive evidence. On the contrary, further studies are needed to assess the utilization of vitamin D regarding the risk of death in patients hospitalized with COVID-19.
·ncbi.nlm.nih.gov·
Protective Effect of Vitamin D Supplementation on COVID-19-Related Intensive Care Hospitalization and Mortality: Definitive Evidence from Meta-Analysis and Trial Sequential Analysis
Ergänzende Behandlung mit Curcumin, Quercetin und Vitamin D bei mildem/moderatem COVID-19 • DGP
Ergänzende Behandlung mit Curcumin, Quercetin und Vitamin D bei mildem/moderatem COVID-19 • DGP
Eine Pilotstudie untersuchte den Effekt einer ergänzenden Behandlung bei mildem bis moderatem COVID-19. Die Nahrungsergänzung beinhaltete Curcumin (aus Kurkuma), Quercetin (z.B. Blattgemüse und Brokkoli) und Vitamin D (Sonnenvitamin), die als entzündungshemmend und antiviral bekannt sind. Mit Hilfe der Ergänzungstherapie in der Frühphase der Erkrankung wurden Patienten schneller wieder negativ getestet. Akutsymptome klärten sich schneller als in der Kontrollgruppe. Blutwerte deuteten zudem darauf, dass die Nahrungsergänzung entzündlichen Prozessen bei COVID-19 entgegenwirkte.
·deutschesgesundheitsportal.de·
Ergänzende Behandlung mit Curcumin, Quercetin und Vitamin D bei mildem/moderatem COVID-19 • DGP
The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients—A Large Population-Based Study
The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients—A Large Population-Based Study
Myocarditis and pericarditis are potential post-acute cardiac sequelae of COVID-19 infection, arising from adaptive immune responses. We aimed to study the incidence of post-acute COVID-19 myocarditis and pericarditis. Retrospective cohort study of 196,992 adults after COVID-19 infection in Clalit Health Services members in Israel between March 2020 and January 2021. Inpatient myocarditis and pericarditis diagnoses were retrieved from day 10 after positive PCR. Follow-up was censored on 28 February 2021, with minimum observation of 18 days. The control cohort of 590,976 adults with at least one negative PCR and no positive PCR were age- and sex-matched. Since the Israeli vaccination program was initiated on 20 December 2020, the time-period matching of the control cohort was calculated backward from 15 December 2020. Nine post-COVID-19 patients developed myocarditis (0.0046%), and eleven patients were diagnosed with pericarditis (0.0056%). In the control cohort, 27 patients had myocarditis (0.0046%) and 52 had pericarditis (0.0088%). Age (adjusted hazard ratio [aHR] 0.96, 95% confidence interval [CI]; 0.93 to 1.00) and male sex (aHR 4.42; 95% CI, 1.64 to 11.96) were associated with myocarditis. Male sex (aHR 1.93; 95% CI 1.09 to 3.41) and peripheral vascular disease (aHR 4.20; 95% CI 1.50 to 11.72) were associated with pericarditis. Post COVID-19 infection was not associated with either myocarditis (aHR 1.08; 95% CI 0.45 to 2.56) or pericarditis (aHR 0.53; 95% CI 0.25 to 1.13). We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection.
·mdpi.com·
The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients—A Large Population-Based Study
The potential impacts of obesity on COVID-19
The potential impacts of obesity on COVID-19
Obese patients are at increased risk of exacerbations from viral respiratory infections. During the H1N1 pandemic, obesity was associated with an increased risk of influenza-associated intensive care unit (ICU) admission and death, longer duration of mechanical ventilation, and longer duration of ICU and hospital length of stay compared with the non-obese. These observations have raised a concern about the correlation between obesity and the current COVID-19 pandemic. In this review, we have outlined the potential impacts of obesity on respiratory physiology and the function of both innate and adaptive immune responses. Also, it has been clearly illustrated that obese patients are potentially more vulnerable to COVID-19 and more contagious than lean patients. The comorbidities associated with obesity were found to be correlated with a severe clinical course of COVID-19 and increased mortality and high BMI has been shown to be correlated with hospitalisation, the need for mechanical ventilation and non-survival. The review also sheds light on the challenges that obese patients pose for healthcare providers inside and outside ICUs.
·rcpjournals.org·
The potential impacts of obesity on COVID-19
Defining post-acute COVID-19 syndrome (PACS) by an epigenetic biosignature in peripheral blood mononuclear cells - Clinical Epigenetics
Defining post-acute COVID-19 syndrome (PACS) by an epigenetic biosignature in peripheral blood mononuclear cells - Clinical Epigenetics
Post-acute COVID-19 syndrome (PACS) has been defined as symptoms persisting after clearance of a COVID-19 infection. We have previously demonstrated that alterations in DNA methylation (DNAm) status persist in individuals who recovered from a COVID-19 infection, but it is currently unknown if PACS is associated with epigenetic changes. We compared DNAm patterns in patients with PACS with those in controls and in healthy COVID-19 convalescents and found a unique DNAm signature in PACS patients. This signature unravelled modified pathways that regulate angiotensin II and muscarinic receptor signalling and protein–protein interaction networks that have bearings on vesicle formation and mitochondrial function.
·clinicalepigeneticsjournal.biomedcentral.com·
Defining post-acute COVID-19 syndrome (PACS) by an epigenetic biosignature in peripheral blood mononuclear cells - Clinical Epigenetics
Forecasting the trajectory of the COVID-19 pandemic into 2023 under plausible variant and intervention scenarios: a global modelling study
Forecasting the trajectory of the COVID-19 pandemic into 2023 under plausible variant and intervention scenarios: a global modelling study
Background The recent Omicron-related waves of the COVID-19 pandemic have resulted in unprecedented levels of population transmission due to the variant’s high level of infectiousness across most of the world. China, the last large country to end its “zero-COVID” policies, is currently facing its own massive Omicron-related wave, and the final impact of that wave remains uncertain. We have seen repeatedly that the epidemiological characteristics of new variants can have profound impacts on global health outcomes. While the characteristics of these new variants are difficult to predict ahead of their emergence, considering the impact of potential future scenarios is of central importance for prudent planning and policy making. This paper samples across a range of potential variant-level characteristics to provide global forecasts of infections, hospitalisations, and deaths in the face of ongoing Omicron-related transmission and waning levels of past immunity and evaluates a range of interventions that may diminish the impact of future waves. Methods We created a susceptible-exposed-infectious dynamic model that accounts for vaccine uptake and effectiveness, antiviral administration, the emergence of new variants, and waning protection from both infection- and vaccine-derived immunity. Using this model, we first estimated past infections, hospitalisations, and deaths by variant, location, and day. We used these findings to more fully understand the global progression of the COVID-19 pandemic through December 12, 2022. Second, we forecasted these same outcome measures under five potential variant emergence scenarios. Third, we evaluated three different interventions in isolation and in concert within each potential variant scenario, to assess the impact of available intervention strategies through June 30, 2023. Findings We estimated that from November 15, 2021, through December 12, 2022, there were 8.60 billion (95% uncertainty interval [UI] 6.37–11.7) SARS-CoV-2 infections, 13.1 million (10.6–16.5) hospitalisations, and 3.04 million (2.65–3.55) deaths, the majority of which were attributable to Omicron variants (98.5% [97.4–99.1] of infections, 82.6% [76.7–86.3] of hospitalisations, and 72.4% [66.4–76.0] of deaths). Compared to the pre-Omicron pandemic period from January 1, 2020, to November 15, 2021, we estimated that there were more than twice as many infections (214% [163–286]) globally from November 15, 2021, to December 12, 2022, but only 20.6% (19.8–21.4) of the estimated deaths. The massive Omicron waves and high vaccination rates in many high-income countries have together contributed to high levels of immunity against SARS-CoV-2 infection, leaving only 97.3% (96.3–98.2) of the global population with no protection as of December 1, 2022. Concurrently, however, China, where only 17.6% [5.28–34.8] of the population have ever experienced infection due to its zero-COVID policy, requires special attention over the next few months, as all our future scenarios predict substantial increases in transmission, hospitalisation, and death in China in now that zero-COVID policies have been relaxed. Under the future scenario we consider most plausible (a scenario with another new Omicron-like variant emerging and reference levels of the drivers of transmission), we estimated there will be an additional 5.19 billion (3.11–7.78) infections, 13.6 million (8.50–21.8) hospitalisations, and 2.74 million (1.40–5.68) deaths between December 12, 2022, and June 30, 2023, with the Western Pacific region projected to sustain the highest rates of additional deaths, driven primarily by the uncontained outbreak in China. By comparison, a baseline scenario in which no new variant emerges results in 3.54 billion (2.24–5.43) infections, 6.26 million (4.11–9.65) hospitalisations, and 1.58 million (0.829–3.95) deaths in the same forecast period. The ability for a new variant to break through past infection- and vaccine-derived immunity greatly influences future outcomes: we estimate a new variant with the high severity of Delta, but correspondingly moderate immunity breakthrough rates will have difficulty overtaking current variants and will result in similar outcomes to the Omicron-like variant scenario with 3.64 billion (2.26–5.83) new infections, 7.87 million (4.81–13.0) new hospitalisations, and 2.87 million (1.03–5.56) new deaths. Finally, if we consider a variant that combines the high infectiousness and breakthrough rates of Omicron with the high severity of Delta, we again estimate 5.19 billion (3.11–7.78) new infections, but due to the presumed increase in severe outcomes, we estimate 30.2 million (13.4–51.2) new hospitalisations and 15.9 million (4.31–35.9) deaths over the forecasted period. The impacts of interventions vary by variant characteristics and region of the world, with increased mask usage and reimplementation of some mandates having massive impact in some regions while having less impact in others. Finally, assuming variant spread was as rapid as observed for Omicron, we find almost no impact of a rapidly developed and deployed variant-targeted booster. Interpretation As infection-derived and vaccine-conferred protection wanes, we expect infections to rise, but as most of the world’s population has some level of immunity to SARS-CoV-2 as of December 12, 2022, all but the most pessimistic forecasts in this analysis do not predict a massive global surge by June 30, 2023. Paradoxically, China, due to its lower levels of population immunity and effective vaccination will likely experience substantial numbers of infections and deaths that, due to its large population size, will adversely affect the global toll. This could be substantially mitigated by existing intervention options including masking, vaccination, health-care preparedness, and effective antiviral compounds for those at most at risk of poor outcomes. While still resulting in morbidity and mortality, this endemic transmission provides protection from less transmissible variants and particularly protects against sub-lineages of the more severe pre-Omicron variants. In the scenarios where a new variant does emerge and spread globally, however, the speed of this spread may be too fast to rely on even the most quickly developed mRNA vaccines to provide protection soon enough. Existing vaccines and boosters have played an important role in increasing immunity worldwide, but the continued contribution of mask usage (both past and future) in the prevention of infection and death cannot be understated. The characteristics of future COVID-19 variants are inherently difficult to predict, and our forecasts do show considerable differences in outcomes as a function of these variant properties. Given the uncertainty surrounding what type of variant will next emerge, the world would be wise to remain vigilant in 2023 as we move to the next phase of the COVID-19 pandemic. Funding Bill & Melinda Gates Foundation, J. Stanton, T. Gillespie, and J. and E. Nordstrom. Evidence before this study Since the beginning of the COVID-19 pandemic, there have been a plethora of COVID-19 models developed; most were designed to focus on a specific location (or small set of locations) and a short time horizon (usually less than a month). A number of modelling consortiums were created to develop ensemble predictions across models of this sort (e.g., the COVID-19 Forecast Hub [maintained by the Reich Lab of the University of Massachusetts Amherst in collaboration with USA CDC (Centers for Disease Control)] or the European COVID-19 Forecast Hub [created by a multitude of infectious disease modelling teams and coordinated by ECDC (European Centre for Disease Prevention and Control)]), and the final results typically predicted four weeks, and at most, six weeks forward. The models combined for these ensembles ran the spectrum from transmission dynamic models that incorporated complex mixing patterns between individuals, to machine learning models that were agnostic of the fact that the input and output were associated with infectious diseases. Moreover, most of these models were designed to predict the most likely outcome as opposed to evaluate potential future scenarios. A small subset of these models were created with this sort of flexibility, though they have primarily been applied to limited global regions (e.g., USA CDC scenarios) and they typically do not evaluate multiple potential scenarios three to six months into the future. The Institute for Health Metrics and Evaluation (IHME) COVID-19 model has been generating and publishing forecasts of SARS-CoV-2 infections and COVID-19 deaths globally with four-month time horizons and making these available at mostly weekly intervals on its website since March 26, 2020 (). The cadence has now slowed to monthly updates as in many parts of the world, data needed to support the modelling of COVID-19 have reduced and/or ceased to be collected as the attention of policy makers and funders is drawn elsewhere. Several epidemiological scenarios have been evaluated in these online estimates, but the outcomes have not been formally compared across these scenarios globally into 2023. This article is also the first full formal documentation of the IHME-SEI model incorporating foundation work on infection–fatality ratio, more robust cumulative infection calculations, as well as more recently developed work that allows for waning immunity. Added value of this study To our knowledge, this study is the first to forecast multiple future COVID-19 scenarios of variant emergence against a background of high rates of past SARS-CoV-2 exposure globally, nationally, and for a set of subnational locations, six months into the future. It is also one of the first to forecast the impact of China relaxing its zero-COVID policy. The scenarios considered were selected to represent a range of realistic potential futures and are directly comparable by region, country...
·medrxiv.org·
Forecasting the trajectory of the COVID-19 pandemic into 2023 under plausible variant and intervention scenarios: a global modelling study
Multiomic characterisation of the long-term sequelae of SARS survivors: a clinical observational study
Multiomic characterisation of the long-term sequelae of SARS survivors: a clinical observational study
Although health outcomes continued to improve, our study suggested that SARS survivors still suffered from physical fatigue, osteoporosis, and necrosis of the femoral head 18 years after discharge, possibly related to plasma metabolic disorders and immunological alterations.
·thelancet.com·
Multiomic characterisation of the long-term sequelae of SARS survivors: a clinical observational study
Live free and die the sad state of u s life expectancy
Live free and die the sad state of u s life expectancy
Just before Christmas, federal health officials confirmed life expectancy in America had dropped for a nearly unprecedented second year in a row – down to 76 years. While countries all over the world saw life expectancy rebound during the second year of the pandemic after the arrival of vaccines, the U.S. did not. Then, last week, more bad news: Maternal mortality in the U.S. reached a high in 2021. Also, a paper in the Journal of the American Medical Association found rising mortality rates among U.S. children and adolescents. "This is the first time in my career that I've ever seen [an increase in pediatric mortality] – it's always been declining in the United States for as long as I can remember," says the JAMA paper's lead author Steven Woolf, director emeritus of the Center on Society and Health at Virginia Commonwealth University. "Now, it's increasing at a magnitude that has not occurred at least for half a century." Across the lifespan, and across every demographic group, Americans die at younger ages than their counterparts in other wealthy nations.
·npr.org·
Live free and die the sad state of u s life expectancy
Developing a blood cell-based diagnostic test for myalgic encephalomyelitis/chronic fatigue syndrome using peripheral blood mononuclear cells
Developing a blood cell-based diagnostic test for myalgic encephalomyelitis/chronic fatigue syndrome using peripheral blood mononuclear cells
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is characterized by debilitating fatigue that profoundly impacts patients’ lives. Diagnosis of ME/CFS remains challenging, with most patients relying on self-report, questionnaires, and subjective measures to receive a diagnosis, and many never receiving a clear diagnosis at all. In this study, we utilized a single-cell Raman platform and artificial intelligence to analyze blood cells from 98 human subjects, including 61 ME/CFS patients of varying disease severity and 37 healthy and disease controls. Our results demonstrate that Raman profiles of blood cells can distinguish between healthy individuals, disease controls, and ME/CFS patients with high accuracy (91%), and can further differentiate between mild, moderate, and severe ME/CFS patients (84%). Additionally, we identified specific Raman peaks that correlate with ME/CFS phenotypes and have the potential to provide insights into biological changes and support the development of new therapeutics. This study presents a promising approach for aiding in the diagnosis and management of ME/CFS, and could be extended to other unexplained chronic diseases such as long COVID and post-treatment Lyme disease syndrome, which share many of the same symptoms as ME/CFS. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research project was support by an ME Association project grant to KM. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the Research Ethics Committees at the University of Oxford (Reference number: R51826/RE001) and by the UCL Biobank Ethical Review Committee-Royal Free (B-ERC-RF) London NHS Foundation Trust (Reference number: EC.2017.012). Ethical approval for sample and data collection and storage was granted by the London School of Hygiene & Tropical Medicine (LSHTM) Ethics Committee (Ref. 6123) and the National Research Ethics Service (NRES) London-Bloomsbury Research Ethics Committee (REC ref. 11/10/1760, IRAS ID:77765). Samples were provided by the UK ME/CFS Biobank (UKMEB) in accordance with a Material Transfer Agreement signed by the London School of Hygiene & Tropical Medicine and the University of Oxford. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced are available online at .
·medrxiv.org·
Developing a blood cell-based diagnostic test for myalgic encephalomyelitis/chronic fatigue syndrome using peripheral blood mononuclear cells
COVID-19, SARS and MERS: A neurological perspective
COVID-19, SARS and MERS: A neurological perspective
Officially declared as a global pandemic by the World Health Organisation (WHO) on 11 March 2020, the COVID-19 (Coronavirus Disease 19) outbreak has evolved at an unprecedented rate. Following its emergence in Wuhan, the capital of the Hubei province, People’s Republic of China, in December 2019, the total number of confirmed coronavirus cases worldwide has already surpassed 2,900,000 as of 28 April 2020 [1], with actual figures believed to be even higher. The virus responsible for the COVID-19 pandemic, initially designated as “2019-nCoV” (2019 novel coronavirus), was later renamed to “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2), given its similarity to the previous SARS-CoV.
·jocn-journal.com·
COVID-19, SARS and MERS: A neurological perspective
Assessing the age specificity of infection fatality rates for COVID-19: systematic review, meta-analysis, and public policy implications - PubMed
Assessing the age specificity of infection fatality rates for COVID-19: systematic review, meta-analysis, and public policy implications - PubMed
Determine age-specific infection fatality rates for COVID-19 to inform public health policies and communications that help protect vulnerable age groups. Studies of COVID-19 prevalence were collected by conducting an online search of published articles, preprints, and government reports that were pu …
·pubmed.ncbi.nlm.nih.gov·
Assessing the age specificity of infection fatality rates for COVID-19: systematic review, meta-analysis, and public policy implications - PubMed
White Paper on Singapore’s Response to COVID-19
White Paper on Singapore’s Response to COVID-19
After three years battling the COVID-19 pandemic, Singapore has moved into a new normal of living with COVID-19. This White Paper crystallises the Government’s reflections on the important lessons to be drawn from the pandemic and our response as a nation. Where we have done well, we will cement these gains for the future. Where there have been shortcomings in our response, we will identify and tackle them, to be better prepared for the next pandemic. Find out more about our response to COVID-19 in the White Paper below. For more information, please refer to the PMO's press release. Members of public may share their feedback on the White Paper at reach@reach.gov.sg, or fill up the form here.
·gov.sg·
White Paper on Singapore’s Response to COVID-19
Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine
Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine
Background The purpose of this study was to evaluate whether a bivalent COVID-19 vaccine protects against COVID-19. Methods Employees of Cleveland Clinic in employment when the bivalent COVID-19 vaccine first became available, were included. Cumulative incidence of COVID-19 over the following 26 weeks was examined. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression, with change in dominant circulating lineages over time accounted for by time-dependent coefficients. The analysis was adjusted for the pandemic phase when the last prior COVID-19 episode occurred, and the number of prior vaccine doses. Results Among 51017 employees, COVID-19 occurred in 4424 (8.7%) during the study. In multivariable analysis, the bivalent vaccinated state was associated with lower risk of COVID-19 during the BA.4/5 dominant (HR, .71; 95% C.I., .63-.79) and the BQ dominant (HR, .80; 95% C.I., .69-.94) phases, but decreased risk was not found during the XBB dominant phase (HR, .96; 95% C.I., .82-.1.12). Estimated vaccine effectiveness (VE) was 29% (95% C.I., 21%-37%), 20% (95% C.I., 6%-31%), and 4% (95% C.I., -12%-18%), during the BA.4/5, BQ, and XBB dominant phases, respectively. Risk of COVID-19 also increased with time since most recent prior COVID-19 episode and with the number of vaccine doses previously received. Conclusions The bivalent COVID-19 vaccine given to working-aged adults afforded modest protection overall against COVID-19 while the BA.4/5 lineages were the dominant circulating strains, afforded less protection when the BQ lineages were dominant, and effectiveness was not demonstrated when the XBB lineages were dominant. Summary Among 51017 working-aged Cleveland Clinic employees, the bivalent COVID-19 vaccine was 29% effective in preventing infection while the BA.4/5 lineages were dominant, and 20% effective while the BQ lineages were. Effectiveness was not demonstrated when the XBB lineages were dominant. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board of Cleveland Clinic gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
·medrxiv.org·
Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine
Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis
Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis
Numerous non-pharmaceutical interventions (NPIs) were taken worldwide to contain the spread of the COVID-19 pandemic. We aimed at providing an overview of randomized trials assessing NPIs to prevent COVID-19. Methods: We included all randomized trials assessing NPIs to prevent COVID-19 in any country and setting registered in ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform using the COVID-evidence platform (until 17 August 2021). We searched for corresponding publications in MEDLINE/PubMed, Google Scholar, the Living Overview of Evidence platform (L-OVE), and the Cochrane COVID-19 registry as well as for results posted in registries. Results: We identified 41 randomized trials. Of them, 11 were completed (26.8%) including 7 with published results. The 41 trials planned to recruit a median of 1,700 participants (IQR, 588 to 9,500, range 30 to 35,256,399) with a median planned duration of 8 months (IQR, 3 to 14, range 1 to 24). Most came from the United States (n=11, 26.8%). The trials mostly assessed protective equipment (n=11, 26.8%), COVID-19-related information and education programs (n=9, 22.0%), access to mass events under specific safety measures (n=5, 12.2%), testing and screening strategies (n=5, 12.2%), and hygiene management (n=5, 12.2%). Conclusions: Worldwide, 41 randomized trials assessing NPIs have been initiated with published results available to inform policy decisions for only 7 of them. A long-term research agenda including behavioral, environmental, social, and systems level interventions is urgently needed to guide policies and practices in the current and future public health emergencies.
·medrxiv.org·
Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis
Neurodevelopment of Offspring of Mothers With SARS-CoV-2 Infection During Pregnancy
Neurodevelopment of Offspring of Mothers With SARS-CoV-2 Infection During Pregnancy
This cohort study examines the risk for neurodevelopmental disorders among male and female offspring exposed in utero to SARS-CoV-2 and whether pregnancy during the COVID-19 pandemic is associated with neurodevelopmental risk independent of SARS-CoV-2 exposure.
·jamanetwork.com·
Neurodevelopment of Offspring of Mothers With SARS-CoV-2 Infection During Pregnancy
SARS‐CoV‐2 infection during pregnancy linked to higher risk of neurodevelopmental disorders in male infants
SARS‐CoV‐2 infection during pregnancy linked to higher risk of neurodevelopmental disorders in male infants
New research led by investigators at Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB), found that males but not females born to mothers with SARS‐CoV‐2 infection ...
·medicalxpress.com·
SARS‐CoV‐2 infection during pregnancy linked to higher risk of neurodevelopmental disorders in male infants