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Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial.
Bravo, L, Smolenov, I, Han, HH, Li, P, Hosain, R, Rockhold, F, Clemens, SAC, Roa, C, Borja-Tabora, C, Quinsaat, A, et al
Lancet (London, England). 2022;(10323):461-472
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Abstract
BACKGROUND A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019. METHODS This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 μg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020-004272-17) and ClinicalTrials.gov (NCT04672395). FINDINGS 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8), 83·7% (97·86% CI 55·9-95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3-100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3-90·4) for delta, 91·8% (44·9-99·8) for gamma, and 58·6% (13·3-81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63-103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups. INTERPRETATION Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant. FUNDING Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.
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Alarming increase in ketoacidosis in children and adolescents with newly diagnosed type 1 diabetes during the first wave of the COVID-19 pandemic in Israel.
Goldman, S, Pinhas-Hamiel, O, Weinberg, A, Auerbach, A, German, A, Haim, A, Zung, A, Brener, A, Strich, D, Azoulay, E, et al
Pediatric diabetes. 2022;(1):10-18
Abstract
OBJECTIVE To evaluate the incidence and severity of ketoacidosis (DKA) at type 1 diabetes diagnosis during the first wave of the coronavirus disease 2019 (COVID-19) pandemic in Israel. RESEARCH DESIGN AND METHODS A population-based study the product of a national collaboration of Israeli pediatric diabetes centers investigated the presentation of childhood-onset type 1 diabetes. The frequencies of DKA and severe DKA observed during the COVID-19 period from March 15, 2020 (commencement of the first nationwide lockdown) until June 30, 2020 were compared with the same periods in 2019, 2018, and 2017 using multivariable logistic regression, adjusting for age, sex, and socioeconomic position. RESULTS During the COVID-19 period, DKA incidence was 58.2%, significantly higher than in 2019 (adjusted OR [aOR] 2.18 [95% CI, 1.31-3.60], P = 0.003); 2018 (aOR 2.05 [95% CI, 1.26-3.34], P = 0.004); and 2017 (aOR, 1.79 [95% CI, 1.09-2.93], P = 0.022). The incidence of severe DKA was 19.9%, significantly higher than in 2018 (aOR, 2.49 [95% CI, 1.20-5.19], P = 0.015) and 2017 (aOR, 2.73 [95% CI, 1.28-5.82], P = 0.009). In 2020, admissions and duration of stay in the intensive care unit were higher than in previous years (P = 0.001). During the COVID-19 pandemic, children aged 6-11 years had higher incidences of DKA (61.3% vs. 34.0%, 40.6%, and 45.1%, respectively, P = 0.012), and severe DKA (29.3% vs. 15.1%, 10.9%, and 5.9%, respectively, P = 0.002). CONCLUSIONS The dramatic increase in DKA at presentation of childhood-onset type 1 diabetes during the COVID-19 pandemic mandates targeted measures to raise public and physician awareness.
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Prevalence and predictors of suboptimal glycemic control among patients with type 2 diabetes mellitus in northern Thailand: A hospital-based cross-sectional control study.
Yeemard, F, Srichan, P, Apidechkul, T, Luerueang, N, Tamornpark, R, Utsaha, S
PloS one. 2022;(1):e0262714
Abstract
BACKGROUND Suboptimal glycemic control among patients with type 2 diabetes mellitus (DM) is a significant public health problem, particularly among people living with poor education and economic statuses, including those with a unique dietary culture. This study aimed to estimate the prevalence and identify the factors associated with suboptimal glycemic control among patients with type 2 DM during the coronavirus disease-2019 (COVID-19) pandemic. METHODS A hospital-based cross-sectional study was used to elicit information from DM patients attending six hospitals located in Chiang Rai Province, northern Thailand, between February and May 2021. A validated questionnaire and 5 mL blood specimens were used as the research tools. Glycated hemoglobin (HbA1c) greater than 7.0% among DM patients at least two years after diagnosis was defined as suboptimal glycemic control. Chi-square tests and logistic regression were used to identify the associations between variables at the significance level α = 0.05. RESULTS A total of 967 patients were recruited for this study; 54.8% 530 had suboptimal glycemic control, 58.8% were female, 66.5% were aged 50-69 years, and 78.5% were married (78.5%). Six variables were found to be associated with suboptimal glycemic control in multivariable logistic regression. Participants aged <49, 50-59, and 60-69 years had 3.32 times (95% CI = 1.99-5.53), 2.61 times (95% CI = 1.67-4.08), and 1.93 times (95% CI = 1.26-2.95) greater odds of having suboptimal glycemic control, respectively, than those aged ≥70 years. Married individuals had 1.64 times (95% CI = 1.11-2.41) greater odds of having suboptimal glycemic control than those ever married. Participants who consumed sticky rice had 1.61 times (95% CI = 1.19-2.61) greater odds of having suboptimal glycemic control than those who did not consume sticky rice in daily life. Participants who had been diagnosed with DM for 11-20 years and ≥21 years had 1.98 times (95% CI = 1.37-2.86) and 2.46 times (1.50-4.04) greater odds of having suboptimal glycemic control, respectively, than those who had been diagnosed ≤ 10 years. Participants who had experienced forgetting to take their medication had 2.10 times (95% CI = 1.43-3.09) greater odds of having suboptimal glycemic control than those who did not, and those who had their medical expenses covered by the national scheme had 2.67 times (95% CI = 1.00-7.08) greater odds of suboptimal glycemic control than those who self-paid. CONCLUSION Effective health interventions to control blood glucose among DM patients during ongoing treatment are urgently required. The interventions should focus on patients aged less than 69 years, marital status, forgetting to take their medication, and a longer time since diagnosis, including reducing their sticky rice consumption. The effects of copayments should also be considered.
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Dietary Habits before and during the COVID-19 Epidemic in Selected European Countries.
Skotnicka, M, Karwowska, K, Kłobukowski, F, Wasilewska, E, Małgorzewicz, S
Nutrients. 2021;(5)
Abstract
UNLABELLED During the so-called "second wave of the pandemic" in Europe, the authors conducted a cross-sectional online survey that aimed to examine changes in dietary habits and associated practices, as well as physical activity during the COVID-19 pandemic and before the onset of lockdowns in three European countries: Poland, Austria and the United Kingdom. METHODS The online observational study, both prospective and retrospective, conducted with the use of social media for the distribution of an anonymous online questionnaire, was completed from 1 October to 30 October 2020, during the second wave of the pandemic in Europe. The study encompassed a total of 1071 adults from Poland (n = 407), Austria (n = 353) and the United Kingdom (n = 311). RESULTS The results of this study indicate that the COVID-19 confinement period influenced eating behavior and the level of physical activity in a group of adult residents of Poland, Austria and the United Kingdom. The general shopping frequency decreased, regardless of the place and manner. However, there was an increased interest in online grocery shopping. The resulting data revealed an increased frequency of the daily consumption of food products such as dairy, grains, fats, vegetables and sweets (p < 0.05). A rise in the frequency of purchasing frozen goods and food with long shelf life has also been observed. The changed workplace and working conditions or unemployment probably affected a perceptible rise in alcohol consumption (p = 0.02). In turn, physical activity levels markedly decreased, which reflected the body mass changes. CONCLUSION The dietary habits in the studied countries have changed as a result of the pandemic situation. They contribute to the aggravation of the problem of excess body weight and its health consequences.
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Social Distancing in Chronic Migraine during the COVID-19 Outbreak: Results from a Multicenter Observational Study.
Di Stefano, V, Ornello, R, Gagliardo, A, Torrente, A, Illuminato, E, Caponnetto, V, Frattale, I, Golini, R, Di Felice, C, Graziano, F, et al
Nutrients. 2021;(4)
Abstract
BACKGROUND The restrictions taken to control the rapid spread of COVID-19 resulted in a sudden, unprecedented change in people's lifestyle, leading to negative consequences on general health. This study aimed to estimate the impact of such changes on migraine severity during 2020 March-May lockdown. METHODS Patients affected by migraine with or without aura, diagnosed by expert physicians, completed a detailed interview comprehensive of: assessment of migraine characteristics; measure of physical activity (PA) levels; measure of the intake frequency of main Italian foods; the Insomnia Severity Index (ISI) questionnaire investigating sleep disorders. RESULTS We included 261 patients with a mean age of 44.5 ± 12.3 years. During social distancing, 72 patients (28%) reported a headache worsening, 86 (33%) an improvement, and 103 (39%) a stable headache frequency. A significant decrease of the PA levels during COVID-19 quarantine in the whole study sample was observed (median total metabolic equivalent task (METs) decreased from 1170 to 510; p < 0.001). Additionally, a significant difference was reported on median ISI scores (from 7 to 8; p < 0.001), which were increased in patients who presented a stable or worsening headache. CONCLUSIONS Our study confirmed that the restrictions taken during the pandemic have affected the practice of PA levels and sleep quality in migraine. Hence, PA and sleep quality should be assessed to find strategies for an improvement in quality of life.
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CT-derived Chest Muscle Metrics for Outcome Prediction in Patients with COVID-19.
Schiaffino, S, Albano, D, Cozzi, A, Messina, C, Arioli, R, Bnà, C, Bruno, A, Carbonaro, LA, Carriero, A, Carriero, S, et al
Radiology. 2021;(2):E328-E336
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Abstract
Background Lower muscle mass is a known predictor of unfavorable outcomes, but its prognostic impact on patients with COVID-19 is unknown. Purpose To investigate the contribution of CT-derived muscle status in predicting clinical outcomes in patients with COVID-19. Materials and Methods Clinical or laboratory data and outcomes (intensive care unit [ICU] admission and death) were retrospectively retrieved for patients with reverse transcriptase polymerase chain reaction-confirmed SARS-CoV-2 infection, who underwent chest CT on admission in four hospitals in Northern Italy from February 21 to April 30, 2020. The extent and type of pulmonary involvement, mediastinal lymphadenopathy, and pleural effusion were assessed. Cross-sectional areas and attenuation by paravertebral muscles were measured on axial CT images at the T5 and T12 vertebral level. Multivariable linear and binary logistic regression, including calculation of odds ratios (ORs) with 95% CIs, were used to build four models to predict ICU admission and death, which were tested and compared by using receiver operating characteristic curve analysis. Results A total of 552 patients (364 men and 188 women; median age, 65 years [interquartile range, 54-75 years]) were included. In a CT-based model, lower-than-median T5 paravertebral muscle areas showed the highest ORs for ICU admission (OR, 4.8; 95% CI: 2.7, 8.5; P < .001) and death (OR, 2.3; 95% CI: 1.0, 2.9; P = .03). When clinical variables were included in the model, lower-than-median T5 paravertebral muscle areas still showed the highest ORs for both ICU admission (OR, 4.3; 95%: CI: 2.5, 7.7; P < .001) and death (OR, 2.3; 95% CI: 1.3, 3.7; P = .001). At receiver operating characteristic analysis, the CT-based model and the model including clinical variables showed the same area under the receiver operating characteristic curve (AUC) for ICU admission prediction (AUC, 0.83; P = .38) and were not different in terms of predicting death (AUC, 0.86 vs AUC, 0.87, respectively; P = .28). Conclusion In hospitalized patients with COVID-19, lower muscle mass on CT images was independently associated with intensive care unit admission and in-hospital mortality. © RSNA, 2021 Online supplemental material is available for this article.
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Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe.
Jung, C, Fjølner, J, Bruno, RR, Wernly, B, Artigas, A, Bollen Pinto, B, Schefold, JC, Wolff, G, Kelm, M, Beil, M, et al
Critical care (London, England). 2021;(1):344
Abstract
BACKGROUND The primary aim of this study was to assess the outcome of elderly intensive care unit (ICU) patients treated during the spring and autumn COVID-19 surges in Europe. METHODS This was a prospective European observational study (the COVIP study) in ICU patients aged 70 years and older admitted with COVID-19 disease from March to December 2020 to 159 ICUs in 14 European countries. An electronic database was used to register a number of parameters including: SOFA score, Clinical Frailty Scale, co-morbidities, usual ICU procedures and survival at 90 days. The study was registered at ClinicalTrials.gov (NCT04321265). RESULTS In total, 2625 patients were included, 1327 from the first and 1298 from the second surge. Median age was 74 and 75 years in surge 1 and 2, respectively. SOFA score was higher in the first surge (median 6 versus 5, p < 0.0001). The PaO2/FiO2 ratio at admission was higher during surge 1, and more patients received invasive mechanical ventilation (78% versus 68%, p < 0.0001). During the first 15 days of treatment, survival was similar during the first and the second surge. Survival was lower in the second surge after day 15 and differed after 30 days (57% vs 50%) as well as after 90 days (51% vs 40%). CONCLUSION An unexpected, but significant, decrease in 30-day and 90-day survival was observed during the second surge in our cohort of elderly ICU patients. The reason for this is unclear. Our main concern is whether the widespread changes in practice and treatment of COVID-19 between the two surges have contributed to this increased mortality in elderly patients. Further studies are urgently warranted to provide more evidence for current practice in elderly patients. TRIAL REGISTRATION NUMBER NCT04321265 , registered March 19th, 2020.
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The Impact of COVID-19 on Eating Environments and Activity in Early Childhood Education and Care in Alberta, Canada: A Cross-Sectional Study.
Lafave, LMZ, Webster, AD, McConnell, C, Van Wyk, N, Lafave, MR
Nutrients. 2021;(12)
Abstract
Early childhood education and care (ECEC) environments influence children's early development and habits that track across a lifespan. The purpose of this study was to explore the impact of COVID-19 government-mandated guidelines on physical activity (PA) and eating environments in ECEC settings. This cross-sectional study involved the recruitment of 19 ECEC centers pre-COVID (2019) and 15 ECEC centers during COVID (2020) in Alberta, Canada (n = 34 ECEC centers; n = 83 educators; n = 361 preschoolers). Educators completed the CHEERS (Creating Healthy Eating and activity Environments Survey) and MEQ (Mindful Eating Questionnaire) self-audit tools while GT3X+ ActiGraph accelerometers measured preschooler PA. The CHEERS healthy eating environment subscale was greater during COVID-19 (5.97 ± 0.52; 5.80 ± 0.62; p = 0.02) and the overall score positively correlated with the MEQ score (r = 0.20; p = 0.002). Preschoolers exhibited greater hourly step counts (800 ± 189; 649 ± 185), moderate-to-vigorous PA (MVPA) (9.3 ± 3.0 min/h; 7.9 ± 3.2 min/h) and lower sedentary times (42.4 ± 3.9 min/h; 44.1 ± 4.9 min/h) during COVID-19 compared to pre-COVID, respectively (p < 0.05). These findings suggest the eating environment and indices of child physical activity were better in 2020, which could possibly be attributed to a change in government-mandated COVID-19 guideline policy.
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Extracorporeal membrane oxygenation support for SARS-CoV-2: a multi-centered, prospective, observational study in critically ill 92 patients in Saudi Arabia.
Alhumaid, S, Al Mutair, A, Alghazal, HA, Alhaddad, AJ, Al-Helal, H, Al Salman, SA, Alali, J, Almahmoud, S, Alhejy, ZM, Albagshi, AA, et al
European journal of medical research. 2021;(1):141
Abstract
BACKGROUND Extracorporeal membrane oxygenation (ECMO) has been used as a rescue strategy in patients with severe with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection, but there has been little evidence of its efficacy. OBJECTIVES To describe the effect of ECMO rescue therapy on patient-important outcomes in patients with severe SARS-CoV-2. METHODS A case series study was conducted for the laboratory-confirmed SARS-CoV-2 patients who were admitted to the ICUs of 22 Saudi hospitals, between March 1, 2020, and October 30, 2020, by reviewing patient's medical records prospectively. RESULTS ECMO use was associated with higher in-hospital mortality (40.2% vs. 48.9%; p = 0.000); lower COVID-19 virological cure (41.3% vs 14.1%, p = 0.000); and longer hospitalization (20.2 days vs 29.1 days; p = 0.000), ICU stay (12.6 vs 26 days; p = 0.000) and mechanical ventilation use (14.2 days vs 22.4 days; p = 0.000) compared to non-ECMO group. Also, there was a high number of patients with septic shock (19.6%) and multiple organ failure (10.9%); and more complications occurred at any time during hospitalization [pneumothorax (5% vs 29.3%, p = 0.000), bleeding requiring blood transfusion (7.1% vs 38%, p = 0.000), pulmonary embolism (6.4% vs 15.2%, p = 0.016), and gastrointestinal bleeding (3.3% vs 8.7%, p = 0.017)] in the ECMO group. However, PaO2 was significantly higher in the 72-h post-ECMO initiation group and PCO2 was significantly lower in the 72-h post-ECMO start group than those in the 12-h pre-ECMO group (62.9 vs. 70 mmHg, p = 0.002 and 61.8 vs. 51 mmHg, p = 0.042, respectively). CONCLUSION Following the use of ECMO, the mortality rate of patients and length of ICU and hospital stay were not improved. However, these findings need to be carefully interpreted, as most of our cohort patients were relatively old and had multiple severe comorbidities. Future randomized trials, although challenging to conduct, are highly needed to confirm or dispute reported observations.
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A Smart Mobile Application to Monitor Visual Function in Diabetic Retinopathy and Age-Related Macular Degeneration: The CLEAR Study.
Khurana, RN, Hoang, C, Khanani, AM, Steklov, N, Singerman, LJ
American journal of ophthalmology. 2021;:222-230
Abstract
PURPOSE The purpose of this study was to determine if a mobile application, the Checkup Vision Assessment System, could reliably monitor visual acuity (VA) and metamorphopsia remotely versus standard VA reference tests in the clinic. With the current COVID-19 pandemic, an even greater need for remote monitoring exists. Mobile tools enhance the ability to monitor patients virtually by enabling remote monitoring of VA and Amsler grid findings. DESIGN Prospective, multicenter reliability analysis. METHODS Participants: Patients (N = 108) with near corrected VA better than 20/200 and a diagnosis of age-related macular degeneration, diabetic retinopathy, or healthy patients without retinal disease (best-corrected visual acuity [BCVA] of 20/32 or better). INTERVENTION participants were tested using the Checkup, reference VA, and Amsler tests, with the order of testing (Checkup or reference) randomized. Patients monitored their vision using Checkup at least twice a week at home between office visits. Main outcome measurements were near corrected VA and Amsler grid test results. RESULTS Agreement was strong between Checkup and reference tests for VA (r = 0.86) and Amsler grid (sensitivity: 93%; specificity: 92%). Home versus clinic testing showed excellent agreement (r = 0.96). Patients reported successful home use. There were no serious adverse events or discontinuations. Patients rated the usability of Checkup to be excellent. CONCLUSIONS There was good agreement between Checkup and in-clinic test results for VA and Amsler grid. The low variance of Checkup testing, agreement between in-clinic and home results, and excellent usability support Checkup as a reliable method for monitoring retinal pathology in clinic and home settings.