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Abstract Propose Pregnancy is a risk factor for severe COVID-19. Treatment with monoclonal antibodies has been shown to decrease the risk of progression to severe COVID-19, but there are few reports on treating pregnant women. Here, we describe the clinical outcome of seven hospitalized pregnant women treated with the casirivimab–imdevimab. Methods/Results Seven unvaccinated pregnant patients hospitalized due to COVID-19 met the monoclonal antibodies treatment criteria applied at our center. After consultations with obstetricians, the decisions to administer casirivimab–imdevimab to halt the progression of COVID-19 were made by two senior infectious diseases specialists. No patient experienced an adverse drug reaction, and only one patient progressed to severe disease. Two patients had a cesarian section performed during hospitalization, both with delivery of healthy babies. Three patients gave birth to healthy babies at a later time point, while two pregnancies are ongoing. Conclusion The hospitalized pregnant patients who received monoclonal antibodies due to COVID-19 had favorable outcomes, but further research is recommended to fully assess safety and efficacy of monoclonal antibody treatment in pregnancy. …

Abstract Purpose This multicenter observational study was done to evaluate risk factors related to the development of BSI in patients admitted to ICU for COVID-19. Methods All patients with COVID-19 admitted in two COVID-19 dedicated ICUs in two different hospital between 02–2020 and 02–2021 were recruited. Result 537 patients were included of whom 265 (49.3%) experienced at least one BSI. Patients who developed bacteremia had a higher SOFA score [10 (8–12) vs 9 (7–10), p < 0.001], had been intubated more frequently [95.8% vs 75%, p < 0.001] and for a median longer time [16 days (9–25) vs 8 days (5–14), p < 0.001]. Patients with BSI had a median longer ICU stay [18 days (12–31.5) vs 9 days (5–15), p < 0.001] and higher mortality [54% vs 42.3%, p < 0.001] than those who did not develop it. Development of BSI resulted in a higher SOFA score [aHR 1.08 (95% CI 1.03–1.12)] and a higher Charlson score [csAHR 1.15 (95% CI 1.05–1.25)]. Conclusion A high SOFA score and a high Charlson score resulted associated with BSI’s development. Conversely, immunosuppressive therapy like steroids and tocilizumab, has no role in increasing the risk of bacteremia. …

Abstract Purpose Reactive arthritis is acute aseptic arthritis occurring 1 to 4 weeks after a distant infection in a genetically predisposed individual. It may occur after COVID-19 infection. We summarize, in this article, the current findings of reactive arthritis following COVID-19 infection. Methods A literature search has been performed from December 2019 to December 2021. We included case reports of reactive arthritis occurring after COVID-19 infection. We collected demographic, clinical, and paraclinical data. Results A total of 22 articles were reviewed. There were 14 men and 11 women with a mean age of 44.96 + 17.47 years. Oligoarticular involvement of the lower limbs was the most frequent clinical presentation. The time between arthritis and COVID infection ranged from 6 to 48 days. The diagnosis was based on clinical and laboratory findings. The pharmacological management was based on non-steroidal anti-inflammatory drugs in 20 cases. Systemic or local steroid therapy was indicated in 13 patients. Sulfasalazine was indicated in two cases. Alleviation of symptoms and recovery were noted in 22 cases. The mean duration of the clinical resolution was 16 + 57 days. Conclusion The diagnosis of reactive arthritis should be considered in patients with a new onset of arthritis following COVID-19 infection. Its mechanism is still unclear. …

Abstract Purpose The benefits of antiviral treatment with remdesivir in hospitalized patients with COVID-19 remain controversial. Clinical analyses are needed to demonstrate which patient populations are most likely to benefit. Methods In a retrospective monocentric analysis, patients with COVID-19 treated between July 1, 2020 and June 30, 2021 at Hospital St. Georg, Leipzig, Germany were evaluated. The primary endpoint was time to clinical improvement, and the secondary endpoint was 28-day mortality. Propensity score matching was used for the endpoint analysis. Results A total of 839 patients were fully evaluated, 68% of whom received specific COVID-19 drug therapy. Remdesivir was used in 31.3% of the patients, corticosteroids in 61.7%, and monoclonal antibodies in 2.3%. While dexamethasone administration was the most common therapeutic approach during the second pandemic wave, combination therapy with remdesivir and corticosteroids predominated during the third wave. Cox regression analysis revealed that combination therapy was not associated with faster clinical improvement (median: 13 days in both matched groups, HR 0.97 [95% CI 0.77–1.21], P = 0.762). By contrast, 28-day mortality was significantly lower in the corticosteroid-remdesivir group (14.8% versus 22.2% in the corticosteroid group, HR 0.60 [95% CI 0.39–0.95], P = 0.03) in the low-care setting. This effect was also demonstrated in a subgroup analysis of patients with remdesivir monotherapy (n = 44) versus standard of care (SOC). Conclusion In COVID-19 patients with only mild disease (low-flow oxygen therapy and treatment in a normal ward) who received corticosteroids and/or remdesivir in addition to SOC, early administration of remdesivir was associated with a measurable survival benefit. …

Abstract Molecular diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time reverse transcription polymerase chain reaction (RT-PCR) in respiratory specimens is considered the gold standard method. This method is highly sensitive and specific but it has some limitations such as being expensive and requiring special laboratory equipment and skilled personnel. RapidFor™ Antigen Rapid Test Kit is a commercially available Ag-RDT which is produced in Turkey and designed to detect the nucleocapsid antigen of SARS-CoV-2 in nasopharyngeal swab samples. The aim of this study was to evaluate the performance of this novel SARS-CoV-2 antigen detection considering the RT-PCR method as the gold standard. Four hundred forty-four nasopharyngeal swab samples which were collected from the patients who met clinical criteria of COVID-19 from ten centers in Turkey between September 2020 and February 2021 were included in the study. All the nasopharyngeal swab samples were tested for SARS-CoV-2 RNA using commercial RT-PCR kits (Bioeksen and A1 Lifesciences, İstanbul, Turkey) according to the manufacturer’s instructions. Viral loads were assessed according to the cycle threshold (Ct) values. RapidFor™ SARS-CoV-2 antigen test (Vitrosens Biotechnology, Istanbul, Turkey) was used to investigate the presence of SARS-CoV-2 antigen in all samples following the manufacturer’s instructions. Out of 444 nasopharyngeal swab samples tested, 346 (77.9%) were positive and 98 (22.1%) were negative for SARS-CoV-2 RNA by RTPCR. Overall sensitivity of the RapidFor™. Antigen Rapid Test Kit was 80.3% whereas specificity was found to be 87.8%. Positivity rate of rapid antigen test in samples with Ct values over 25 and below 30 was 82.7%, while it increased to 95.7% in samples 20 ≤ Ct < 25 and reached 100% in samples with Ct values below 20. RapidFor™ SARS-CoV-2 Ag test might be a good choice in the screening of symptomatic and asymptomatic patients and their contacts for taking isolation measures early, with advantages over RT-PCR as being rapid, easy and being applicable in every laboratory and even at point of care.…

by Emily Cooper, Adam Lound, Christina J. Atchison, Matthew Whitaker, Caroline Eccles, Graham S. Cooke, Paul Elliott, Helen WardBackground Long COVID is a patient-made term describing new or persistent symptoms experienced following SARS-CoV-2 infection. The Real-time Assessment of Community Transmission-Long COVID (REACT-LC) study aims to understand variation in experiences following infection, and to identify biological, social, and environmental factors associated with Long COVID. We undertook a pilot interview study to inform the design, recruitment approach, and topic guide for the REACT-LC qualitative study. We sought to gain initial insights into the experience and attribution of new or persistent symptoms and the awareness or perceived applicability of the term Long COVID. Methods People were invited to REACT-LC assessment centres if they had taken part in REACT, a random community-based prevalence study, and had a documented history of SARS-CoV-2 infection. We invited people from REACT-LC assessment centres who had reported experiencing persistent symptoms for more than 12 weeks to take part in an interview. We conducted face to face and online semi-structured interviews which were transcribed and analysed using Thematic Analysis. Results We interviewed 13 participants (6 female, 7 male, median age 31). Participants reported a wide variation in both new and persistent symptoms which were often fluctuating or unpredictable in nature. Some participants were confident about the link between their persistent symptoms and COVID-19; however, others were unclear about the underlying cause of symptoms or felt that the impact of public health measures (such as lockdowns) played a role. We found differences in awareness and perceived applicability of the term Long COVID. Conclusion This pilot has informed the design, recruitment approach and topic guide for our qualitative study. It offers preliminary insights into the varied experiences of people living with persistent symptoms including differences in symptom attribution and perceived applicability of the term Long COVID. This variation shows the value of recruiting from a nationally representative sample of participants who are experiencing persistent symptoms.…

by Yuval Shahar, Osnat MokrynEpidemics and pandemics require an early estimate of the cumulative infection prevalence, sometimes referred to as the infection 'Iceberg,' whose tip are the known cases. Accurate early estimates support better disease monitoring, more accurate estimation of infection fatality rate, and an assessment of the risks from asymptomatic individuals. We find the Pivot group, the population sub-group with the highest probability of being detected and confirmed as positively infected. We differentiate infection susceptibility, assumed to be almost uniform across all population sub-groups at this early stage, from the probability of being confirmed positive. The latter is often related to the likelihood of developing symptoms and complications, which differs between sub-groups (e.g., by age, in the case of the COVID-19 pandemic). A key assumption in our method is the almost-random subgroup infection assumption: The risk of initial infection is either almost uniform across all population sub-groups or not higher in the Pivot sub-group. We then present an algorithm that, using the lift value of the pivot sub-group, finds a lower bound for the cumulative infection prevalence in the population, that is, gives a lower bound on the size of the entire infection 'Iceberg.' We demonstrate our method by applying it to the case of the COVID-19 pandemic. We use UK and Spain serological surveys of COVID-19 in its first year to demonstrate that the data are consistent with our key assumption, at least for the chosen pivot sub-group. Overall, we applied our methods to nine countries or large regions whose data, mainly during the early COVID-19 pandemic phase, were available: Spain, the UK at two different time points, New York State, New York City, Italy, Norway, Sweden, Belgium, and Israel. We established an estimate of the lower bound of the cumulative infection prevalence for each of them. We have also computed the corresponding upper bounds on the infection fatality rates in each country or region. Using our methodology, we have demonstrated that estimating a lower bound for an epidemic’s infection prevalence at its early phase is feasible and that the assumptions underlying that estimate are valid. Our methodology is especially helpful when serological data are not yet available to gain an initial assessment on the prevalence scale, and more so for pandemics with an asymptomatic transmission, as is the case with Covid-19.

Molnupiravir did not reduce the frequency of COVID-19-associated hospitalisations or death among high-risk vaccinated adults in the community.

AbstractBackgroundImmunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 Ag assays have also been developed. The number of commercially available SARS-CoV-2 Ag detection tests has increased rapidly, as has the COVID-19 diagnostic literature. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best practice guidance related to SARS-CoV-2 Ag testing. This guideline is an update to the third in a series of frequently updated COVID-19 diagnostic guidelines developed by the IDSA.ObjectiveThe IDSA’s goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and non-medical settings.MethodsA multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. A review of relevant, peer-reviewed published literature was conducted through April 1, 2022. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.ResultsThe panel made ten diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies.ConclusionsU.S. Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared to nucleic acid amplification testing (NAAT). Ag test sensitivity is dependent on the presence or absence of symptoms, and in symptomatic patients, on timing of testing after symptom onset. In contrast, Ag tests have high specificity, and, in most cases, positive Ag results can be acted upon without confirmation. Results of point-of-care testing are comparable to those of laboratory-based testing, and observed or unobserved self-collection of specimens for testing yields similar results. Modeling suggests that repeat Ag testing increases sensitivity compared to testing once, but no empirical data were available to inform this question. Based on these observations, rapid RT-PCR or laboratory-based NAAT remains the testing method of choice for diagnosing SARS-CoV-2 infection. However, when timely molecular testing is not readily available or is logistically infeasible, Ag testing helps identify individuals with SARS-CoV-2 infection. Data were insufficient to make a recommendation about the utility of Ag testing to guide release of patients with COVID-19 from isolation. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.

by Georgina Drago, Francisco Javier Pérez-Sádaba, Susana Aceituno, Carla Gari, Juan Luis López-BelmonteObjectives Describe healthcare resource use and costs per hospitalized coronavirus disease-2019 (COVID-19) patient during the three main outbreak waves. Methods A retrospective observational study. COVID-19 patient data were collected from a dataset from 17 hospitals in the HM Hospitals Group. Mean total costs per hospitalized patient and per day were estimated in each wave, as defined by the Spanish National Health System perspective. In addition, costs were estimated for both patients admitted and those not admitted to the intensive care unit (ICU) and were stratified by age groups. Results A total of 3756 COVID-19 patients were included: 2279 (60.7%) for the first, 740 (19.7%) for the second, and 737 (19.6%) for the and third wave. Most (around 90%) did not require ICU treatment. For those patients, mean ± SD cost per patient ranged from €10 196.1 ± €7237.2 (mean length of stay [LOS] ± SD: 9.7 ± 6.2 days) for the second wave to €9364.5 ± €6321.1 for the third wave (mean 9.0 ± 5.7 days). Mean costs were around €1000 per day for all the waves. For patients admitted to the ICU, cost per patient ranged from €81 332.5 ± €63 725.8 (mean 31.0 ± 26.3 days) for the second wave to €36 952.1 ± €24 809.2 (mean 15.7 ± 8.2 days) for the third wave. Mean costs per day were around €3000 for all the waves. When estimated by age, mean LOS and costs were greater in patients over 80 when not admitted to the ICU and for patients aged 60 to 79 when admitted to the ICU. Conclusions LOS was longer for patients admitted to the ICU (especially in the first two waves) and for older patients in our study cohort; these populations incurred the highest hospitalization costs.…

by Alexandros Chrysos, Iakovos Amygdalos, Priscila Nunes, Guenter Haselow, Konstantinos Lioupis, Raphael Rosch, Roman Marius Eickhoff, Georg Wiltberger, Ulf Peter Neumann, Andreas LambertzThis study aimed to observe the impact of the COVID-19 outbreak on acute general surgery in the first German “hotspot” regions of Heinsberg and Aachen, during the first months of the pandemic. The incidence and severity of acute appendicitis, acute cholecystitis and mechanical bowel obstruction, were compared between March and May 2020 and a control period (same months of the previous three years). Pre-, intra- and postoperative data was compared between three regional hospitals of Heinsberg and the closest maximum care, university hospital. A total of 592 operated patients were included, 141 belonging to the pandemic cohort and 451 to the historic cohort. The pandemic group showed higher rates of clinical peritonitis (38% vs. 27%, p = 0.015), higher rates of mean white blood cell count (13.2±4.4 /nl vs. 12.3±4.7 /nl, p = 0.044) and mean C-reactive protein (60.3±81.1 mg/l vs. 44.4±72.6 mg/l, p = 0.015) preoperatively. Specifically in patients with acute appendicitis, there were less patients with catarrhal appendicitis (23% vs. 35%, p = 0.021) and a tendency towards more advanced histological findings in the pandemic cohort. In the university hospital, a 42% reduction in acute operated cases was observed at the onset of the pandemic (n = 30 in 2020 vs. n = 52 in 2019), whereas in the peripheral hospitals of Heinsberg there was only a 10% reduction (n = 111 in 2020 vs. n = 123 in 2019). The onset of the COVID-19 pandemic in our region was accompanied by advanced preoperative and intraoperative findings in patients undergoing emergency general surgery. A greater reduction in acute operated surgical cases was observed at the university hospital, in contrast to the smaller hospitals of Heinsberg, suggesting a possible shift of emergency patients, requiring immediate operation, from maximum care hospital to the periphery.

by Oluwapelumi Olufemi Adeyemi, Nnaemeka Darlington Ndodo, Mariam Kehinde Sulaiman, Oyeronke Temidayo Ayansola, Oluwabunmi Idera Nimat Buhari, Olusola Anuoluwapo Akanbi, Oladimeji Akeem Bolarinwa, Chimaobi Chukwu, Ireoluwa Yinka Joel, Adesuyi Ayodeji Omoare, Kolawole Wasiu Wahab, Celestina Obiekea, Mikhail Olayinka Buhari, Anthony Ahumibe, Caroline Folasade Kolawole, Catherine Okoi, Olumuyiwa Babagbemi Omotesho, Nwando Mba, Oluwafemi Adeniyi, Olajumoke Babatunde, Nathaniel Akintunde, Ganiu Ayinla, Oluwatosin Wuraola Akande, Rasheed Adekeye Odunola, Mohammed Jimoh Saka, Omotosho Ibrahim Musa, Idayat Adenike Durotoye, Chikwe Ihekweazu, Ifedayo Morayo Adetifa, Abayomi FadeyiThe COVID-19 global pandemic is being driven by evolving SARS-CoV-2 variants with consequential implications on virus transmissibility, host immunity, and disease severity. Continuous molecular and genomic surveillance of the SARS-CoV-2 variants is therefore necessary for public health interventions toward the management of the pandemic. This study is a retrospective analysis of COVID-19 cases reported in a Nigerian tertiary institution from July to December 2021. In total, 705 suspected COVID-19 cases that comprised 547 students and 158 non-students were investigated by real time PCR (RT-PCR); of which 372 (~52.8%) tested positive for COVID-19. Using a set of selection criteria, 74 (~19.9%) COVID-19 positive samples were selected for next generation sequencing. Data showed that there were two outbreaks of COVID-19 within the university community over the study period, during which more females (56.8%) tested positive than males (47.8%) (p…

by Nebiyu Mengistu, Endashaw Habtamu, Chalachaw Kassaw, Derebe Madoro, Wondwosen Molla, Aregahegn Wudneh, Lulu Abebe, Bereket DukoBackground Smartphone and social media use are supposed to be integral parts of university students’ daily lives. More specifically, smartphones and social media are frequently used for communication in daily life during the COVID-19 pandemic. Nonetheless, uninterrupted and persistent use of these technologies may lead to several psychological problems. Even though smartphones and social media were used more frequently during the pandemic, there is no evidence suggesting that the studies were not undertaken in low-income countries, including Ethiopia. Therefore, the current study aimed to assess problematic smartphone use and social media use among undergraduate university students in southern Ethiopia. Methods A cross-sectional study was carried out among 1,232 university students using a simple random sampling technique. The Bergen Social Media Addiction Scale and Smartphone Application-Based Addiction Scale were used to collect data on social media and smartphone use, respectively. The Beck Depression Inventory, Generalized Anxiety Assessment Tool, Rosenberg Self-Esteem Scale, and Pittsburg Sleep Quality Index were standardized tools used to measure other independent variables. To identify factors, simple and multiple linear regression analyses were performed. A p-value of 0.05 was used to determine statistical significance. Results The overall response rate was 95%. The mean scores for problematic smartphone and problematic social media use were 17 ± 3.3/36 and 12.7 ± 2.2/30, respectively. A linear regression model revealed that being female, first-year students and poor sleep quality were significantly associated with problematic smartphone use. Factors associated with problematic social media use (PSMU) were depression, substance use, and urban residence. Conclusions This study identified significant problems with smartphone and social media use among university students. Therefore, it is preferable to provide psychological counselling, educate students about safe, beneficial, and healthy internet use, and focus on recognized high-risk groups in order to give them special attention. It is also preferable to seek counselling about substance use. It is preferable to regularly screen and treat individuals with psychological problems in collaboration with stakeholders.…

by Shun Sun Wong, Charng Choon Wong, Kwok Wen Ng, Mohammad F. Bostanudin, Suk Fei TanIntroduction This study aims to assess the impacts of COVID-19 pandemics among university students in Malaysia, by identifying the prevalence of depression, anxiety and stress among them and their respective predictors. Methodology An online cross-sectional study was conducted via non-probabilistic convenience sampling. Data were collected on sociodemographic characteristics, lifestyle, COVID-19 related influences. Mental health status was assessed with depression, anxiety, and stress scale (DASS-21). Results 388 students participated this study (72.4% female; 81.7% Bachelor’s student). The prevalence of moderate to severe depression, anxiety and stress among university students are 53.9%, 66.2% and 44.6%, respectively. Multivariable logistic regression analysis found that the odds of depression were lower among students who exercise at least 3 times per week (OR: 0.380, 95% CI: 0.203–0.711). The odd ratio of student who had no personal history of depression to had depression, anxiety and stress during this pandemic was also lower in comparison (OR: 0.489, 95% CI: 0.249–0.962; OR: 0.482, 95% CI: 0.241–0.963; OR: 0.252, 95% CI: 0.111–0.576). Surprisingly, students whose are currently pursuing Master study was associated with lower stress levels (OR: 0.188, 95% CI: 0.053–0.663). However, student who had poorer satisfaction of current learning experience were more likely to experience stress (OR: 1.644, 95% CI: 1.010–2.675). Limitations It is impossible to establish causal relationships between variables on mental health outcomes, and there is a risk of information bias. Conclusion The prevalence of mental health issues among university students is high. These findings present essential pieces of predictive information when promoting related awareness among them.…

by Alice Bertoletti, Mara Soncin, Marta Cannistrà, Tommaso AgasistiThe disruption caused by the Covid-19 pandemic generated an unprecedented situation, in which digital learning, in the form of Emergency Remote Teaching, was the only possible form of schooling. Italy soon decided to close schools as a measure to counter the spread of the virus. Although the Ministry of Education suggested general guidelines, school principals and teachers were autonomous in deciding how to best organise their educational activities. The first objective of our study is to identify subgroups of teachers, based on the use of digital tools during the Covid-19 emergency. Secondly, we explore how subgroups differ in terms of teachers’ satisfaction and students’ performance. To this end, we integrate information from an ad hoc survey completed by 1,407 primary and lower secondary teachers in Italy, with the students’ standardised test scores provided by INVALSI. Data have been analysed through a 3-step latent class analysis. The findings reveal that one third of the teachers showed resistance to the use of digital technologies and focused mainly on asynchronous teaching. Teachers that used a broader set of digital instruments, instead, were more satisfied with their teaching practices. A more articulated use of technology for teaching activities was also positively associated with higher students’ performance in 2021.

Abstract Purpose The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) has caused substantial mortality worldwide. We investigated clinical and demographic features of COVID-19-related deaths that occurred between March 2020 and January 2022 in Regensburg, Germany. Methods We compared data across four consecutive time periods: March 2020 to September 2020 (period 1), October 2020 to February 2021 (period 2), March 2021 to August 2021 (period 3), and September 2021 to January 2022 (period 4). Results Overall, 405 deaths in relation to COVID-19 were reported. The raw case fatality ratio (CFR) was 0.92. In periods 1 to 4, the CFRs were 1.70%, 2.67%, 1.06%, and 0.36%. The age-specific CFR and mortality were highest in persons aged ≥ 80 years in period 2 while mortality in younger cases increased with time. The median age at death was 84 years and it varied slightly across periods. Around 50% of cases of death were previously hospitalized. In all time periods, the cause of death was mostly attributed to COVID-19. Over the four periods, we did not find significant changes in the distribution of sex and risk factors for severe disease. The most frequent risk factor was cardio-circulatory disease. Conclusion In conclusion, the CFR decreased over time, most prominently for period 4. Mortality was considerable and younger cases were increasingly at risk. …

On 29 January 2020, the first SARS-CoV-2 case was notified in Italy [1,2] and, by 21 February 2022, almost 12 million confirmed cases and 150,000 deaths from COVID-19 had been recorded in the country [3].

The COVID-19 pandemic has highlighted the high diagnostic accuracy of the nasopharyngeal swab (including in intensive care unit (ICU) patients. This study aimed to compare nasopharyngeal swab and bronchoalveolar lavage (BAL) results for non-SARS-CoV-2 viruses in patients with suspected pneumonia.

by Romana Haneef, Myriam Fayad, Anne Fouillet, Cécile Sommen, Christophe Bonaldi, Grant M. A. Wyper, Sara Monteiro Pires, Brecht Devleesschauwer, Antoine Rachas, Panayotis Constantinou, Daniel Levy-Bruhl, Nathalie Beltzer, Anne GallayBackground The World Health Organization declared a pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on March 11, 2020. The standardized approach of disability-adjusted life years (DALYs) allows for quantifying the combined impact of morbidity and mortality of diseases and injuries. The main objective of this study was to estimate the direct impact of COVID-19 in France in 2020, using DALYs to combine the population health impact of infection fatalities, acute symptomatic infections and their post-acute consequences, in 28 days (baseline) up to 140 days, following the initial infection. Methods National mortality, COVID-19 screening, and hospital admission data were used to calculate DALYs based on the European Burden of Disease Network consensus disease model. Scenario analyses were performed by varying the number of symptomatic cases and duration of symptoms up to a maximum of 140 days, defining COVID-19 deaths using the underlying, and associated, cause of death. Results In 2020, the estimated DALYs due to COVID-19 in France were 990 710 (1472 per 100 000), with 99% of burden due to mortality (982 531 years of life lost, YLL) and 1% due to morbidity (8179 years lived with disability, YLD), following the initial infection. The contribution of YLD reached 375%, assuming the duration of 140 days of post-acute consequences of COVID-19. Post-acute consequences contributed to 49% of the total morbidity burden. The contribution of YLD due to acute symptomatic infections among people younger than 70 years was higher (67%) than among people aged 70 years and above (33%). YLL among people aged 70 years and above, contributed to 74% of the total YLL. Conclusions COVID-19 had a substantial impact on population health in France in 2020. The majority of population health loss was due to mortality. Men had higher population health loss due to COVID-19 than women. Post-acute consequences of COVID-19 had a large contribution to the YLD component of the disease burden, even when we assume the shortest duration of 28 days, long COVID burden is large. Further research is recommended to assess the impact of health inequalities associated with these estimates.…

by Meng Hua, Lin WangThe effectiveness of the blended teaching model in improving university students’ English learning achievement has been frequently reported in China in the post-pandemic era. However, such research has seldom explored the students’ entire EFL (English as a foreign language) learning process and mechanism from the perspective of learners within this model. This study therefore used the 3P (presage, process and product) teaching and learning theory to explore the mediating role of learning methods (i.e., learning engagement and academic procrastination) in the relationship between learning preparation (i.e., academic self-concept and course experience) and learning achievement within the Chinese EFL blended teaching context from the perspective of learners. In this study, 942 Chinese university students (male: N = 447; female: N = 495) participated in a survey and completed electronic questionnaires on EFL-related academic self-concept, learning engagement, academic procrastination, and learning achievement. The data were analyzed using AMOS software and a structural equation modeling (SEM) technique. The results showed that both students’ academic self-concept and course experience directly and positively predicted their English learning achievement. Moreover, students’ academic self-concept of learning achievement was partially mediated by learning engagement and academic procrastination, whereas the effect of course experience on learning achievement was fully mediated by learning engagement and academic procrastination. After discussing these findings, suggestions as well as limitations for future studies will be given.

by Maika Takahashi, Kaori Saito, Tomohiko Ai, Shuko Nojiri, Abdullah Khasawneh, Faith Jessica Paran, Yuki Horiuchi, Satomi Takei, Takamasa Yamamoto, Mitsuru Wakita, Makoto Hiki, Takashi Miida, Toshio Naito, Kazuhisa Takahashi, Yoko TabeBackground Despite the worldwide campaigns of COVID-19 vaccinations, the pandemic is still a major medical and social problem. The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodies. However, it has not been evaluated in Japan, where the total cases and death toll are lower than the rest of the world. Methods The clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine. Results VITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19. Conclusions Although the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results.…

Abstract Purpose The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) has caused substantial mortality worldwide. We investigated clinical and demographic features of COVID-19-related deaths that occurred between March 2020 and January 2022 in Regensburg, Germany. Methods We compared data across four consecutive time periods: March 2020 to September 2020 (period 1), October 2020 to February 2021 (period 2), March 2021 to August 2021 (period 3), and September 2021 to January 2022 (period 4). Results Overall, 405 deaths in relation to COVID-19 were reported. The raw case fatality ratio (CFR) was 0.92. In periods 1 to 4, the CFRs were 1.70%, 2.67%, 1.06%, and 0.36%. The age-specific CFR and mortality were highest in persons aged ≥ 80 years in period 2 while mortality in younger cases increased with time. The median age at death was 84 years and it varied slightly across periods. Around 50% of cases of death were previously hospitalized. In all time periods, the cause of death was mostly attributed to COVID-19. Over the four periods, we did not find significant changes in the distribution of sex and risk factors for severe disease. The most frequent risk factor was cardio-circulatory disease. Conclusion In conclusion, the CFR decreased over time, most prominently for period 4. Mortality was considerable and younger cases were increasingly at risk. …

From December 30, 2019, to May 14, 2022, 517,648,631 people were infected with coronavirus disease 2019 (COVID-19), and 6,261,708 people died in total. The male-to-female ratio was 0.9 among infected people and 1.29 in deceased people [1]. According to the U.S. Centers for Disease Control and Prevention (CDC, https://www.cdc.gov/, last accessed 05/09/22), 207,793 pregnant women in the United States were infected, and 296 died.

Abstract Background Around the world, policymakers have clearly communicated that COVID-19 vaccination programs need to be accepted by a large proportion of the population to allow life return to normal. However, according to the Center for Disease Control, about 31% of the United States population had not completed the primary vaccination series as of November 2022. Aims The primary aim of this work is to identify the factors associated by American citizens with the decision to be vaccinated against COVID-19. In addition, the proportion of fatal events from COVID-19 vaccinations was estimated and compared with the data in the VAERS database. Methods An online survey of COVID-19 health experiences was conducted. Information was collected regarding reasons for and against COVID-19 inoculations, experiences with COVID-19 illness and COVID-19 inoculations by survey respondents and their social circles. Logit regression analyses were carried out to identify factors influencing the likelihood of being vaccinated. Results A total of 2840 participants completed the survey between December 18 and 23, 2021. 51% (1383 of 2840) of the participants were female and the mean age was 47 (95% CI 46.36–47.64) years. Those who knew someone who experienced a health problem from COVID-19 were more likely to be vaccinated (OR: 1.309, 95% CI 1.094–1.566), while those who knew someone who experienced a health problem following vaccination were less likely to be vaccinated (OR: 0.567, 95% CI 0.461–0.698). 34% (959 of 2840) reported that they knew at least one person who had experienced a significant health problem due to the COVID-19 illness. Similarly, 22% (612 of 2840) of respondents indicated that they knew at least one person who had experienced a severe health problem following COVID-19 vaccination. With these survey data, the total number of fatalities due to COVID-19 inoculation may be as high as 278,000 (95% CI 217,330–332,608) when fatalities that may have occurred regardless of inoculation are removed. Conclusion Knowing someone who reported serious health issues either from COVID-19 or from COVID-19 vaccination are important factors for the decision to get vaccinated. The large difference in the possible number of fatalities due to COVID-19 vaccination that emerges from this survey and the available governmental data should be further investigated. …

Abstract Background Post-COronaVIrus Disease 2019 (COVID-19) conditions (PCC) include multiple symptoms afflicting different organs and systems. To evaluate the frequency and type of them, we described our multidisciplinary approach with preliminary results of the first enrolled patients. Methods We included patients aged ≥ 18 years with hospital admission for confirmed SARS-CoV-2 infection. Symptoms were grouped in five macro groups hereafter referred to as "Symptoms Category" (SC): respiratory SC (dyspnoea or cough), neurological SC (peripheral neuropathies, headache, impaired mobility, behavioural disorders), psychological SC (sleep disorders, mood disorders), muscular SC (arthromyalgia, asthenia), other SC (fever, alopecia, diarrhoea, weight loss, smell and taste alterations, sexual dysfunctions). SC were evaluated at discharge and at follow-up. Association between patients’ characteristics and presence of SC at follow up was estimated by a logistic multivariable regression model. Results From June 2020 to July 2021, we followed up 361 patients: 128 (35.5%) who were previously admitted to Intensive Care Unit (ICU) and 233 patients to ordinary department. The median length of hospital stay was 20 days (Inter-Quartile-Range 13–32). Most patients (317/361, 87.8%) were still symptomatic at discharge, with one third referring three or more SC. At follow up, 67.3% (243/361) of patients still complained at least one SC. Moreover, 159 patients (44%) developed at least one new involved SC during follow up: 116 (72.9%) one SC, 39 (24.5%) two SC, 4 (2.5%) three or more SC. At follow up visit 130 of 361 (36%) were still with SC developed during follow up. At multivariable analysis presence of any SC at follow-up was associated with male gender (Odds Ratio [OR] 3.23, Confidence Interval [CI] 95% 1.46–7.15), ICU admission (OR 2.78, CI 95% 1.29–5.96) and presence of SC at discharge (OR 14.39, CI 95% 6.41–32.32). Conclusions In our sample of patients with severe COVID-19, we found that PCC are highly variable and fluctuating over time; in particular, in about 50% of our patients new SC appear during follow up. Moreover, presence of PCC also in patients without SC at discharge and the variability of symptoms underlining the advisability of our multidisciplinary approach. Trial registration number: ClinicalTrials.gov Identifier: NCT04424992, registered on 28 February 2020 https://www.clinicaltrials.gov/ct2/results?recrs=ab&cond=&term=NCT04424992&cntry=&state=&city=&dist  The current version of protocol is version 1.0 enrolling since June 2020. The enrollment is still ongoing. …

Abstract Background The effect of angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) on mortality was preliminarily explored through the comparison of ACEIs/ARBs with non-ACEIs/ARBs in patients with coronavirus disease 2019 (COVID-19). Reaching a conclusion on whether previous ACEI/ARB treatment should be continued in view of the different ACE2 levels in the comparison groups was not unimpeachable. Therefore, this study aimed to further elucidate the effect of ACEI/ARB continuation on hospital mortality, intensive care unit (ICU) admission, and invasive mechanical ventilation (IMV) in the same patient population. Methods We searched PubMed, the Cochrane Library, Ovid, and Embase for relevant articles published between December 1, 2019 and April 30, 2022. Continuation of ACEI/ARB use after hospitalization due to COVID-19 was considered as an exposure and discontinuation of ACEI/ARB considered as a control. The primary outcome was hospital mortality, and the secondary outcomes included 30-day mortality, rate of ICU admission, IMV, and other clinical outcomes. Results Seven observational studies and four randomized controlled trials involving 2823 patients were included. The pooled hospital mortality in the continuation group (13.04%, 158/1212) was significantly lower than that (22.15%, 278/1255) in the discontinuation group (risk ratio [RR] = 0.45; 95% confidence interval [CI], 0.28–0.72; P = 0.001). Continuation of ACEI/ARB use was associated with lower rates of ICU admission (10.5% versus 16.2%, RR = 0.63; 95% CI 0.5–0.79; P < 0.0001) and IMV (8.2% versus 12.5%, RR = 0.62; 95% CI 0.46–0.83, P = 0.001). Nevertheless, the effect was mainly demonstrated in the observational study subgroup (P < 0.05). Continuing ACEI/ARB had no significant effect on 30-day mortality (P = 0.34), acute myocardial infarction (P = 0.08), heart failure (P = 0.82), and acute kidney injury after hospitalization (P = 0.98). Conclusion Previous ACEI/ARB treatment could be continued since it was associated with lower hospital deaths, ICU admission, and IMV in patients with COVID-19, although the benefits of continuing use were mainly shown in observational studies. More evidence from multicenter RCTs are still needed to increase the robustness of the data. Trial registration PROSPERO (CRD42022341169). Registered 27 June 2022 …

Life expectancy in the US decreased by about a half year between 2020 and 2021, from 77 years to 76.4 years, according to final 2021 mortality data from the National Center for Health Statistics. Life expectancy in 2021 was at its lowest level since 1996. The report attributed the drop mainly to increased deaths from COVID-19 and drug overdoses.

The COVID-19 pandemic caught society unprepared. The lack of therapeutic agents for coronaviruses led to a scramble to investigate approved medications for repurposing against SARS-CoV-2. Successes were achieved with immunomodulatory agents for the inflammatory disease processes of COVID-19, but the antiviral search has been less productive. One of the more interesting therapeutic candidates investigated is fluvoxamine.

This randomized, placebo-controlled platform trial compares the use of low-dose fluvoxamine (50 mg twice daily) for 10 days compared with placebo in outpatients with mild to moderate COVID-19.

This study evaluates the adoption of clinician billing for patient portal messages as e-visits, prompted by significant increases in patient messaging after the onset of the COVID-19 pandemic.

by Ahmed Omar Bali, Hussam Al Halbusi, Araz Ramazan Ahmad, Ka Yiu LeeBackground Social media has been a common platform to disseminate health information by government officials during the COVID-19 pandemic. However, little is known about the determinants of public engagement in officials’ posts on social media, especially during lockdown. Objectives This study aims to investigate how the public engages in officials’ posts about COVID-19 on social media and to identify factors influencing the levels of engagement. Methods A total of 511 adults aged 18 or over completed an online questionnaire during lockdown in Iraq. Levels of engagement in officials’ posts on social media, trust in officials and compliance of government instructions were assessed. Results Fear of COVID-19 and trust in officials were positively associated with compliance of government instructions. Trust in officials was also associated with active engagement in officials’ posts on social media, including commenting, posting and sharing of the posts. Conclusions Trust in government has been established during the COVID-19 pandemic. Public engagement in officials’ posts is crucial to reinforce health policies and disseminate health information.…

by Pirko Tõugu, Tiia Tulviste, Lisa SchröderThe present study focused on parent-child conversations about COVID-19 related changes in children’s lives in Estonia and Germany with an aim to understand how children’s conceptual understanding of the disease and their emotional security is created and reflected in these interactions. Twenty-nine parent-child dyads from both cultural contexts provided self-recorded conversations. The conversations were analyzed for the type of explanations, emotional content, and valence. Estonian conversations were longer than those of German dyads. Explanatory talk appeared in both contexts but was general in nature. Conversations in both cultural contexts also included very few emotional references and tended to focus on both positive and negative aspects of the situation. The conversations show that parents tend to support children’s coping with stressful situations by helping them conceptually understand COVID-19 and paying little attention to children’s comprehension of feelings about the situation.

by Raja Dhar, John Kirkpatrick, Laura Gilbert, Arjun Khanna, Mahavir Madhavdas Modi, Rakesh K. Chawla, Sonia Dalal, Venkata Nagarjuna Maturu, Marcel Stern, Oliver T. Keppler, Ratko Djukanovic, Stephan D. GadolaBackground After admission to hospital, COVID-19 progresses in a substantial proportion of patients to critical disease that requires intensive care unit (ICU) admission. Methods In a pragmatic, non-blinded trial, 387 patients aged 40–90 years were randomised to receive treatment with SoC plus doxycycline (n = 192) or SoC only (n = 195). The primary outcome was the need for ICU admission as judged by the attending physicians. Three types of analyses were carried out for the primary outcome: “Intention to treat” (ITT) based on randomisation; “Per protocol” (PP), excluding patients not treated according to randomisation; and “As treated” (AT), based on actual treatment received. The trial was undertaken in six hospitals in India with high-quality ICU facilities. An online application serving as the electronic case report form was developed to enable screening, randomisation and collection of outcomes data. Results Adherence to treatment per protocol was 95.1%. Among all 387 participants, 77 (19.9%) developed critical disease needing ICU admission. In all three primary outcome analyses, doxycycline was associated with a relative risk reduction (RRR) and absolute risk reduction (ARR): ITT 31.6% RRR, 7.4% ARR (P = 0.063); PP 40.7% RRR, 9.6% ARR (P = 0.017); AT 43.2% RRR, 10.8% ARR (P = 0.007), with numbers needed to treat (NTT) of 13.4 (ITT), 10.4 (PP), and 9.3 (AT), respectively. Doxycycline was well tolerated with not a single patient stopping treatment due to adverse events. Conclusions In hospitalized COVID-19 patients, doxycycline, a safe, inexpensive, and widely available antibiotic with anti-inflammatory properties, reduces the need for ICU admission when added to SoC.…

by Shaun Liverpool, Mohammed Moinuddin, Supritha Aithal, Michael Owen, Katie Bracegirdle, Meggie Caravotta, Rachel Walker, Ciaran Murphy, Vicky KarkouAim This study aimed to examine the mental health and wellbeing of further and higher education students and the associating factors after returning to face-to-face (in-person) learning after Covid-19 restrictions. Methods A cross-sectional study informed by student consultations was conducted using a survey design. Mental health and wellbeing were assessed using self-report items on the Depression, Anxiety and Stress Scale (DASS-21) and the Short Warwick–Edinburgh Mental Wellbeing Scale (SWEMWBS). Descriptive statistics and stepwise multiple linear regression analyses were conducted on data collected between December 2021 and June 2022. Results N = 1160 students participated; 69.6% between 16 and 25 years, 67.9% studying in the UK, 66.5% studying away from home, 60.2% identified as she/her, 59.8% studying at the undergraduate degree level, 42.5% belonging to non-White ethnic backgrounds, 29.6% identifying as having additional needs and 22.8% as sexual minority. Moderate anxiety (M = 13.67, SD = 9.92) and depression (M = 17.04, SD = 11.56) scores were mainly reported. Wellbeing scores (M = 20.31, SD = 3.93) were lower than the estimate for the pre-pandemic general population. Gender expression, sexuality, age, ethnicity, having additional needs, and level and location of study was associated with mental health or wellbeing. Individual coping styles, levels of self-efficacy and physical activity were also associated with mental health or wellbeing. Conclusions Many students returning to further and higher education after Covid-19 restrictions experienced reduced mental health and wellbeing, and some students were at greater risk. Providing student-centred interventions focusing on self-efficacy, coping styles and physical activity may help improve the mental health and wellbeing of students.…

Since the demonstration of Nirmatrelvir-Ritonavir (NMV-r) efficacy with an 89% relative risk reduction of hospitalization or death in unvaccinated patients, along with a rapid decrease in nasopharyngeal viral load, clinical and virological rebound have been described in NMV-r-receiving patients. However, whether the NMV-r use is associated with a heightened frequency of rebound, and whether this has clinical implications, are still a matter of scientific debate.

Abstract Background Coronavirus disease 2019 is a type of acute infectious pneumonia and frequently confused with influenza since the initial symptoms. When the virus colonized the patient's mouth, it will cause changes of the oral microenvironment. However, few studies on the alterations of metabolism of the oral microenvironment affected by SARS-CoV-2 infection have been reported. In this study, we explored metabolic alterations of oral microenvironment after SARS-CoV-2 infection. Methods Untargeted metabolomics (UPLC-MS) was used to investigate the metabolic changes between oral secretion samples of 25 COVID-19 and 30 control participants. To obtain the specific metabolic changes of COVID-19, we selected 25 influenza patients to exclude the metabolic changes caused by the stress response of the immune system to the virus. Multivariate analysis (PCA and PLS-DA plots) and univariate analysis (students’ t-test) were used to compare the differences between COVID-19 patients and the controls. Online hiplot tool was used to perform heatmap analysis. Metabolic pathway analysis was conducted by using the MetaboAnalyst 5.0 web application. Results PLS-DA plots showed significant separation of COVID-19 patients and the controls. A total of 45 differential metabolites between COVID-19 and control group were identified. Among them, 35 metabolites were defined as SARS-CoV-2 specific differential metabolites. Especially, the levels of cis-5,8,11,14,17-eicosapentaenoic acid and hexanoic acid changed dramatically based on the FC values. Pathway enrichment found the most significant pathways were tyrosine-related metabolism. Further, we found 10 differential metabolites caused by the virus indicating the body’s metabolism changes after viral stimulation. Moreover, adenine and adenosine were defined as influenza virus-specific differential metabolites. Conclusions This study revealed that 35 metabolites and tyrosine-related metabolism pathways were significantly changed after SARS-CoV-2 infection. The metabolic alterations of oral microenvironment in COVID-19 provided new insights into its molecular mechanisms for research and prognostic treatment. …

Abstract Background To support proactive care during the coronavirus pandemic, a digital COVID-19 symptom tracker was deployed in Greater Manchester (UK) care homes. This study aimed to understand what factors were associated with the post-uptake use of the tracker and whether the tracker had any effects in controlling the spread of COVID-19. Methods Daily data on COVID-19, tracker uptake and use, and other key indicators such as staffing levels, the number of staff self-isolating, availability of personal protective equipment, bed occupancy levels, and any problems in accepting new residents were analysed for 547 care homes across Greater Manchester for the period April 2020 to April 2021. Differences in tracker use across local authorities, types of care homes, and over time were assessed using correlated effects logistic regressions. Differences in numbers of COVID-19 cases in homes adopting versus not adopting the tracker were compared via event design difference-in-difference estimations. Results Homes adopting the tracker used it on 44% of days post-adoption. Use decreased by 88% after one year of uptake (odds ratio 0.12; 95% confidence interval 0.06–0.28). Use was highest in the locality initiating the project (odds ratio 31.73; 95% CI 3.76–268.05). Care homes owned by a chain had lower use (odds ratio 0.30; 95% CI 0.14–0.63 versus single ownership care homes), and use was not associated with COVID-19 or staffing levels. Tracker uptake had no impact on controlling COVID-19 spread. Staff self-isolating and local area COVID-19 cases were positively associated with lagged COVID-19 spread in care homes (relative risks 1.29; 1.2–1.4 and 1.05; 1.0–1.1, respectively). Conclusions The use of the COVID-19 symptom tracker in care homes was not maintained except in Locality 1 and did not appear to reduce the COVID-19 spread. COVID-19 cases in care homes were mainly driven by care home local-area COVID-19 cases and infections among the staff members. Digital deterioration trackers should be co-produced with care home staff, and local authorities should provide long-term support in their adoption and use. …

AbstractBackgroundAZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)−specific neutralizing monoclonal antibodies (tixagevimab/cilgavimab).MethodsThis phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study evaluated AZD7442 administered intramuscularly (300 mg) or intravenously (300, 1000, 3000 mg) in healthy adults (aged 18–55 years). The primary endpoint was safety and tolerability. Secondary endpoints included pharmacokinetics and anti-drug antibodies.ResultsBetween August 18–October 16, 2020, 60 participants enrolled; 50 received AZD7442 and 10 received placebo. Adverse events (all of mild/moderate intensity) occurred in 26 (52.0%) and 8 (80.0%) participants (AZD7442 and placebo groups, respectively). No infusion- or injection-site, or hypersensitivity reactions occurred. Tixagevimab and cilgavimab had mean half-lives of approximately 90 days (range: 87.0–95.3 [tixagevimab], 79.8–­91.1 [cilgavimab]) and similar pharmacokinetic profiles over the 361-day study period. SARS-CoV-2–specific neutralizing antibody titers provided by AZD7442 were maintained above those in plasma from convalescent coronavirus disease-19 (COVID-19) patients.ConclusionsAZD7442 was well tolerated in healthy adults, showing a favorable safety profile across all doses. Depending on the SARS-CoV-2 variant, pharmacokinetic analyses suggest AZD7442 could offer protection for at least 6 months against symptomatic COVID-19 following a single 300 mg intramuscular administration.Clinical trials registrationNCT04507256 (https://clinicaltrials.gov/ct2/show/NCT04507256).

Abstract Background With ~ 50 million individuals suffering from post-COVID condition (PCC), low health related quality of life (HRQoL) is a vast problem. Common symptoms of PCC, that persists 3 months from the onset of COVID-19 are fatigue, shortness of breath and cognitive dysfunction. No effective treatment options have been widely adopted in clinical practice. Hyperbaric oxygen (HBO2) is a candidate drug. Methods The objective of this interim analysis is to describe our cohort and evaluate the safety of HBO2 for post covid condition. In an ongoing randomised, placebo-controlled, double blind, clinical trial, 20 previously healthy subjects with PCC were assigned to HBO2 or placebo. Primary endpoints are physical domains in RAND-36; Physical functioning (PF) and Role Physical (RP) at 13 weeks. Secondary endpoints include objective physical tests. Safety endpoints are occurrence, frequency, and seriousness of Adverse Events (AEs). An independent data safety monitoring board (DSMB) reviewed unblinded data. The trial complies with Good Clinical Practice. Safety endpoints are evaluated descriptively. Comparisons against norm data was done using t-test. Results Twenty subjects were randomised, they had very low HRQoL compared to norm data. Mean (SD) PF 31.75 (19.55) (95% Confidence interval; 22.60–40.90) vs 83.5 (23.9) p < 0.001 in Rand-36 PF and mean 0.00 (0.00) in RP. Very low physical performance compared to norm data. 6MWT 442 (180) (95% CI 358–525) vs 662 (18) meters p < 0.001. 31 AEs occurred in 60% of subjects. In 20 AEs, there were at least a possible relationship with the study drug, most commonly cough and chest pain/discomfort. Conclusions An (unexpectedly) high frequency of AEs was observed but the DSMB assessed HBO2 to have a favourable safety profile. Our data may help other researchers in designing trials. Trial Registration ClinicalTrials.gov: NCT04842448. Registered 13 April 2021, https://clinicaltrials.gov/ct2/show/NCT04842448. EudraCT: 2021-000764-30. Registered 21 May 2021, https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000764-30/SE …

Proceedings of the National Academy of Sciences, Volume 120, Issue 4, January 2023.

Abstract Background The purpose of this study was to demonstrate both the four-year prevalence trend of healthcare-associated infections (HAIs) in a large tertiary hospital and the trend regarding the prevalence of HAIs following the outbreak of coronavirus disease 2019 (COVID-19) in order to provide evidence of hospital infection management during the COVID-19 pandemic. Methods Based on the hospital’s electronic nosocomial infection databases related to HAIs, we retrospectively identified the HAI cases to assess the epidemiological characteristics of HAIs from January 1, 2018, to December 31, 2021, in a large tertiary hospital in China. Similarly, the trends of HAIs after the COVID-19 outbreak and the seasonal variation of HAIs were further analyzed. Results The HAI cases (n = 7833) were identified from the inpatients (n = 483,258) during the 4 years. The most frequently occurring underlying cause of HAIs was respiratory tract infections (44.47%), followed by bloodstream infections (11.59%), and urinary tract infections (8.69%). The annual prevalence of HAIs decreased from 2.39% in 2018 to 1.41% in 2021 (P = 0.032), with the overall prevalence of HAIs significantly decreasing since the outbreak of COVID-19 (2.20% in 2018–2019 vs. 1.44% in 2020–2021, P < 0.001). The prevalence of respiratory tract infections decreased most significantly; whereas, overall, the prevalence of HAIs was significantly greater during the winter compared with the rest of the year. Conclusions Not only did the annual prevalence of HAIs decrease from 2018 to 2021, but it also significantly decreased since the start of the COVID-19 pandemic, particularly respiratory tract infections. These results provide evidence for the need to prevent HAIs, especially during the winter season. …

Abstract Background Research on the immune response to inactivated COVID-19 vaccination among people living with HIV (PLWH) is limited, especially among those with low CD4+ T lymphocyte (CD4 cell) count. This prospective cohort study aimed to assess the humoral immune response to inactivated COVID-19 vaccination among PLWH compared to HIV negative controls (HNCs) and to determine the impact of CD4 cell count on vaccine response among PLWH. Methods The neutralizing antibodies (nAbs) and the specific IgM and IgG-binding antibody responses to the inactivated COVID-19 vaccine at the third month after the second dose of inactivated COVID-19 vaccination were measured among 138 PLWH and 35 HNCs. Multivariable logistic regression and multiple linear regression models were conducted to identify factors associated with the seroconversion rate of antibodies and the magnitude of anti-SARS-CoV-2 antibody titers, respectively. Results At the end of the third month after two doses of vaccination, the seroconversion rates of IgG were comparable between PLWH (44.9%; 95% CI 36.5–53.3%) and HNCs (60.0%; 95% CI 42.9–77.1%), respectively. The median titers and seroconversion rate of nAbs among PLWH were 0.57 (IQR: 0.30–1.11) log10 BAU/mL and 29.0% (95% CI 21.3–36.8%), respectively, both lower than those in HNCs (P < 0.05). After adjusting for age, sex, comorbidities, and CD4 cell count, the titers and seroconversion rate of nAbs were comparable between PLWH and HNCs (P > 0.05). Multivariable regression analyses showed that CD4 cell count < 200/μL was independently associated with lower titers and seroconversion rate of nAbs among PLWH (P < 0.05). A positive correlation was observed between the CD4 cell count and nAbs titers in PLWH (Spearman's ρ = 0.25, P = 0.0034). Conclusion Our study concluded that the immune response to inactivated COVID-19 vaccination among PLWH was independently associated with CD4 cell count, PLWH with lower CD4 cell count showed a weaker humoral immune response, especially those with CD4 cell count < 200/μL. This finding suggests that expanding COVID-19 vaccination coverage among PLWH is impendency. In addition, aggressive ART should be carried out for PLWH, especially for those with low CD4 cell count, to improve the immune response to vaccines. …

During the ongoing coronavirus disease 2019 (COVID-19) pandemic, the waning of the second vaccine-induced immunogenicity over time [1, 2] and the emergence of variants of concerns (VOCs), such as Delta and Omicron, have led many countries to adopt the booster (third) vaccine campaign. Observational studies have shown that a third-dose of existing mRNA vaccines is still effective against infection with Delta and Omicron variants and hospitalization [3-5]; however, the third-dose vaccine effectiveness (VE) against Omicron infection is lower than that against Delta [3, 4].

ABSTRACTBackgroundSAB-185, a novel fully-human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for non-hospitalized adults with mild-moderate COVID-19.MethodsParticipants received intravenous SAB-185 3,840 units/kg (low-dose) or placebo, or 10,240 units/kg (high-dose) or placebo. Primary outcome measures were nasopharyngeal SARS-CoV-2 RNA <lower limit of quantification (LLoQ) at study days 3, 7, and 14, time to symptomatic improvement, and safety through day 28.ResultsTwo-hundred thirteen participants received low-dose SAB-185/placebo (n=107/106) and 215 high-dose SAB-185/placebo (n=110/105). The proportions with SARS-CoV-2 RNA <LLoQ were higher for SAB-185 versus placebo at days 3 and 7 and similar at day 14, and significantly higher at day 7 for high-dose SAB versus placebo only, relative risk (95% CI) 1.23 (1.01, 1.49). At day 3, SARS-CoV-2 RNA levels were lower with low-dose and high-dose SAB-185 versus placebo, differences in medians of -0.78 log10copies/mL (p=0.08) and -0.71 log10copies/mL (p=0.10), respectively. No difference was observed in time to symptom improvement: median 11/10 days (p=0.24) for low-dose SAB-185/placebo and 8/10 days (p=0.50) for high-dose SAB-185/placebo. Grade ≥3 adverse events occurred in 5%/13% of low-dose SAB-185/placebo and 9%/12% of high-dose SAB-185/placebo.ConclusionsSAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk non-hospitalized adults with COVID-19.

ObjectiveThis study assesses the role of social capital among people and communities in response to the first wave of the pandemic in 2020.DesignQualitative study using focus group discussions.SettingCapital city (Bangkok) and the four regions (north, northeast, south and central) of Thailand.Participants161 participants of 19 focus groups with diverse backgrounds in terms of gender, profession, education and geography (urban/rural; regions). They are selected for different levels of impact from the pandemic.FindingsThe solidarity among the Thai people was a key contributing factor to societal resilience during the pandemic. Findings illustrate how three levels of social capital structure—family, community and local networks—mobilised resources from internal and external social networks to support people affected by the pandemic. The results also highlight different types of resources mobilised from the three levels of social capital, factors that affect resilience, collective action to combat the negative impacts of the pandemic, and the roles of social media and gender.ConclusionSocial capital plays significant roles in the resilience of individuals, households and communities to respond to and recover from the impacts of the pandemic. In many instances, social capital is a faster and more efficient response than other kinds of formal support. Social capital can be enhanced by interactions and exchanges in the communities. While face-to-face social contacts are challenged by the need for social distancing and travel restrictions, social media steps in as alternative socialisation to enhance social capital.…

Objectives(1) Assess the distribution of skin-to-deltoid-muscle distance (SDMD) at the deltoid intramuscular (IM) injection site; (2) its relationship with demographic and anthropometric variables and (3) Consider the findings in relation to clinical guidance on IM injection, such as COVID-19 vaccines.DesignSystematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesMEDLINE, EMBASE, ClinicalTrials.gov, Cochrane Library, CINAHL and SCOPUS between June and July 2021 with no publication date limit.Eligibility criteriaStudies reporting measurements of the SDMD in living adults aged 16 years and older, at the deltoid IM injection site, published in English were considered.Data extraction and synthesisTwo independent reviewers performed each stage of screening, data extraction and quality assessments using the Joanna Briggs Institute Critical Appraisal Checklist for analytical cross sectional studies.Results16 105 papers were identified, of which 11 studies were suitable for review, representing 1414 participants. Heterogeneity in the definition of the deltoid IM injection site, locations measured and methods of measurement precluded meta-analysis. Evidence from ultrasound SDMD measurements demonstrated some patients in all but ‘underweight’ body mass index (BMI) categories, may require needles longer than 25 mm for successful IM injection. Calliper measurements overestimated SDMD compared with ultrasound. Female sex, higher BMI categories and greater weight in women were associated with greater SDMD.ConclusionsThe reviewed evidence was insufficient to inform definitive needle length ‘cut points’ for IM injection based on demographic or anthropomorphic variables. Contemporary clinical guidance currently based on this evidence, including the site of injection and choice of needle length, may result in subcutaneous administration in a small proportion of recipients, particularly if obese or of female sex.PROSPERO registration numberCRD42021264625.…

IntroductionCall and recall systems provide actionable intelligence to improve equity and timeliness of childhood vaccinations, which have been disrupted during the COVID-19 pandemic. We will evaluate the effectiveness, fidelity and sustainability of a data-enabled quality improvement programme delivered in primary care using an Active Patient Link Immunisation (APL-Imms) call and recall system to improve timeliness and equity of uptake in a multiethnic disadvantaged urban population. We will use qualitative methods to evaluate programme delivery, focusing on uptake and use, implementation barriers and service improvements for clinical and non-clinical primary care staff, its fidelity and sustainability.Methods and analysisThis is a mixed-methods observational study in 284 general practices in north east London (NEL). The target population will be preschool-aged children eligible to receive diphtheria, tetanus and pertussis (DTaP) or measles, mumps and rubella (MMR) vaccinations and registered with an NEL general practice. The intervention comprises an in-practice call and recall tool, facilitation and training, and financial incentives. The quantitative evaluation will include interrupted time Series analyses and Slope Index of Inequality. The primary outcomes will be the proportion of children receiving at least one dose of a DTaP-containing or MMR vaccination defined, respectively, as administered between age 6 weeks and 6 months or between 12 and 18 months of age. The qualitative evaluation will involve a ‘Think Aloud’ method and semistructured interviews of stakeholders to assess impact, fidelity and sustainability of the APL-Imms tool, and fidelity of the implementation by facilitators.Ethics and disseminationThe research team has been granted permission from data controllers in participating practices to use deidentified data for audit purposes. As findings will be specific to the local context, research ethics approval is not required. Results will be disseminated in a peer-reviewed journal and to stakeholders, including parents, health providers and commissioners.…

by The PLOS ONE Staff …

by Serene S. Paul, Angela Hubbard, Justin Johnson, Sarah M. DennisVirtual healthcare has the potential to increase access to allied health for people living in rural areas, but challenges in delivery of such models have been reported. The COVID-19 pandemic provided an opportunity for a rural practice of physiotherapists and exercise physiologists to transition service delivery to a virtual model of care which utilised a combination of phone, video, an exercise app and/or paper handouts. This study aimed to evaluate the uptake and outcomes from virtual delivery of allied health services, and to describe patient and clinician experiences of the virtual model of care. A parallel convergent mixed methods study was conducted. De-identified data from patients who were offered the virtual service between 15 March 2020 and 30 September 2020 were extracted from the database of the rural practice, as were data from patients attending the practice in-person during the same time in 2019 to serve as a historical comparison. De-identified data from a monthly survey tracking clinician experiences of delivering care virtually was also obtained from the practice. Quantitative data were presented descriptively. Between-group differences were compared using independent samples t-tests, and within-group longitudinal changes compared using paired t-tests. Semi-structured interviews were conducted among a purposive sample of patients using the virtual service, and focus groups conducted among clinicians providing this model of care. Qualitative data were recorded and transcribed verbatim, then thematic analysis conducted. During the study period, the practice delivered 4% (n = 242) consultations virtually. Thirty-seven of the 60 patients (62%) using the virtual service were new referrals. Patients attended fewer sessional appointments virtually and a smaller proportion of patients reported high satisfaction with virtual care, compared to those who received in-person care the previous year (p < .05). Clinician confidence in delivering virtual care did not change significantly over time (p>.05), though clinicians not providing virtual care in a given month perceived their lower confidence than those who did provide virtual care (p < .05). Five themes influencing the success of virtual allied health provision emerged from patient interviews and clinician focus groups: adaptation of program elements for virtual delivery, conduct of virtual treatment, clinician flexibility, patient complexity and communication. The theme of communication influenced all the other themes. Virtual healthcare is a potential solution to address lack of access to allied health practitioners in rural areas, but may not suit all patients. Establishing a therapeutic relationship and ensuring people have access to adequate resources prior to virtual care delivery will optimise successful adoption of virtual care models. A hybrid model incorporating limited in-person consultations with virtual consultations appears a more viable option.