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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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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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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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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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Impact of the presence of heart disease, cardiovascular medications and cardiac events on outcome in COVID-19.
Cabezón Villalba, G, Amat-Santos, IJ, Dueñas, C, Lopez Otero, D, Catala, P, Aparisi, A, López-Pais, J, Cacho Antonio, CE, Candela, J, Antúnez Muiños, P, et al
Cardiology journal. 2021;(3):360-368
Abstract
BACKGROUND Cardiovascular risk factors and usage of cardiovascular medication are prevalent among coronavirus disease 2019 (COVID-19) patients. Little is known about the cardiovascular implications of COVID-19. The goal herein, was to evaluate the prognostic impact of having heart disease (HD) and taking cardiovascular medications in a population diagnosed of COVID-19 who required hospitalization. Also, we studied the development of cardiovascular events during hospitalization. METHODS Consecutive patients with definitive diagnosis of COVID-19 made by a positive real time- -polymerase chain reaction of nasopharyngeal swabs who were admitted to the hospital from March 15 to April 14 were included in a retrospective registry. The association of HD with mortality and with mortality or respiratory failure were the primary and secondary objectives, respectively. RESULTS A total of 859 patients were included in the present analysis. Cardiovascular risk factors were related to death, particularly diabetes mellitus (hazard ratio in the multivariate analysis: 1.810 [1.159- -2.827], p = 0.009). A total of 113 (13.1%) patients had HD. The presence of HD identified a group of patients with higher mortality (35.4% vs. 18.2%, p < 0.001) but HD was not independently related to prognosis; renin-angiotensin-aldosterone system inhibitors, calcium channel blockers, diuretics and beta-blockers did not worsen prognosis. Statins were independently associated with decreased mortality (0.551 [0.329-0.921], p = 0.023). Cardiovascular events during hospitalization identified a group of patients with poor outcome (mortality 31.8% vs. 19.3% without cardiovascular events, p = 0.007). CONCLUSIONS The presence of HD is related to higher mortality. Cardiovascular medications taken before admission are not harmful, statins being protective. The development of cardiovascular events during the course of the disease is related to poor outcome.
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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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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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Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-Related Respiratory Failure.
Mathews, KS, Soh, H, Shaefi, S, Wang, W, Bose, S, Coca, S, Gupta, S, Hayek, SS, Srivastava, A, Brenner, SK, et al
Critical care medicine. 2021;(7):1026-1037
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OBJECTIVES Therapies for patients with respiratory failure from coronavirus disease 2019 are urgently needed. Early implementation of prone positioning ventilation improves survival in patients with acute respiratory distress syndrome, but studies examining the effect of proning on survival in patients with coronavirus disease 2019 are lacking. Our objective was to estimate the effect of early proning initiation on survival in patients with coronavirus disease 2019-associated respiratory failure. DESIGN Data were derived from the Study of the Treatment and Outcomes in Critically Ill Patients with coronavirus disease 2019, a multicenter cohort study of critically ill adults with coronavirus disease 2019 admitted to 68 U.S. hospitals. Using these data, we emulated a target trial of prone positioning ventilation by categorizing mechanically ventilated hypoxemic (ratio of Pao2 over the corresponding Fio2 ≤ 200 mm Hg) patients as having been initiated on proning or not within 2 days of ICU admission. We fit an inverse probability-weighted Cox model to estimate the mortality hazard ratio for early proning versus no early proning. Patients were followed until death, hospital discharge, or end of follow-up. SETTING ICUs at 68 U.S. sites. PATIENTS Critically ill adults with laboratory-confirmed coronavirus disease 2019 receiving invasive mechanical ventilation with ratio of Pao2 over the corresponding Fio2 less than or equal to 200 mm Hg. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Among 2,338 eligible patients, 702 (30.0%) were proned within the first 2 days of ICU admission. After inverse probability weighting, baseline and severity of illness characteristics were well-balanced between groups. A total of 1,017 (43.5%) of the 2,338 patients were discharged alive, 1,101 (47.1%) died, and 220 (9.4%) were still hospitalized at last follow-up. Patients proned within the first 2 days of ICU admission had a lower adjusted risk of death compared with nonproned patients (hazard ratio, 0.84; 95% CI, 0.73-0.97). CONCLUSIONS In-hospital mortality was lower in mechanically ventilated hypoxemic patients with coronavirus disease 2019 treated with early proning compared with patients whose treatment did not include early proning.
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Post-extubation dysphagia and dysphonia amongst adults with COVID-19 in the Republic of Ireland: A prospective multi-site observational cohort study.
Regan, J, Walshe, M, Lavan, S, Horan, E, Gillivan Murphy, P, Healy, A, Langan, C, Malherbe, K, Flynn Murphy, B, Cremin, M, et al
Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery. 2021;(6):1290-1299
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OBJECTIVES This study aims to (i) investigate post-extubation dysphagia and dysphonia amongst adults intubated with SARS-COV-2 (COVID-19) and referred to speech and language therapy (SLT) in acute hospitals across the Republic of Ireland (ROI) between March and June 2020; (ii) identify variables predictive of post-extubation oral intake status and dysphonia and (iii) establish SLT rehabilitation needs and services provided to this cohort. DESIGN A multi-site prospective observational cohort study. PARTICIPANTS One hundred adults with confirmed COVID-19 who were intubated across eleven acute hospital sites in ROI and who were referred to SLT services between March and June 2020 inclusive. MAIN OUTCOME MEASURES Oral intake status, level of diet modification and perceptual voice quality. RESULTS Based on initial SLT assessment, 90% required altered oral intake and 59% required tube feeding with 36% not allowed oral intake. Age (OR 1.064; 95% CI 1.018-1.112), proning (OR 3.671; 95% CI 1.128-11.943) and pre-existing respiratory disease (OR 5.863; 95% CI 1.521-11.599) were predictors of oral intake status post-extubation. Two-thirds (66%) presented with dysphonia post-extubation. Intubation injury (OR 10.471; 95% CI 1.060-103.466) and pre-existing respiratory disease (OR 24.196; 95% CI 1.609-363.78) were predictors of post-extubation voice quality. Thirty-seven per cent required dysphagia intervention post-extubation, whereas 20% needed intervention for voice. Dysphagia and dysphonia persisted in 27% and 37% cases, respectively, at hospital discharge. DISCUSSION Post-extubation dysphagia and dysphonia were prevalent amongst adults with COVID-19 across the ROI. Predictors included iatrogenic factors and underlying respiratory disease. Prompt evaluation and intervention is needed to minimise complications and inform rehabilitation planning.
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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.