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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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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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SARS-CoV-2-specific B- and T-cell immunity in a population-based study of young Swedish adults.
Björkander, S, Du, L, Zuo, F, Ekström, S, Wang, Y, Wan, H, Sherina, N, Schoutens, L, Andréll, J, Andersson, N, et al
The Journal of allergy and clinical immunology. 2022;(1):65-75.e8
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BACKGROUND Young adults are now considered major spreaders of coronavirus disease 2019 (COVID-19) disease. Although most young individuals experience mild to moderate disease, there are concerns of long-term adverse health effects. The impact of COVID-19 disease and to which extent population-level immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exists in young adults remain unclear. OBJECTIVE We conducted a population-based study on humoral and cellular immunity to SARS-CoV-2 and explored COVID-19 disease characteristics in young adults. METHODS We invited participants from the Swedish BAMSE (Barn [Children], Allergy Milieu, Stockholm, Epidemiology) birth cohort (age 24-27 years) to take part in a COVID-19 follow-up. From 980 participants (October 2020 to June 2021), we here present data on SARS-CoV-2 receptor-binding domain-specific IgM, IgA, and IgG titers measured by ELISA and on symptoms and epidemiologic factors associated with seropositivity. Further, SARS-CoV-2-specific memory B- and T-cell responses were detected for a subpopulation (n = 108) by ELISpot and FluoroSpot. RESULTS A total of 28.4% of subjects were seropositive, of whom 18.4% were IgM single positive. One in 7 seropositive subjects was asymptomatic. Seropositivity was associated with use of public transport, but not with sex, asthma, rhinitis, IgE sensitization, smoking, or body mass index. In a subset of representative samples, 20.7% and 35.0% had detectable SARS-CoV-2 specific B- and T-cell responses, respectively. B- and T-cell memory responses were clearly associated with seropositivity, but T-cell responses were also detected in 17.2% of seronegative subjects. CONCLUSIONS Assessment of IgM and T-cell responses may improve population-based estimations of SARS-CoV-2 infection. The pronounced surge of both symptomatic and asymptomatic infections among young adults indicates that the large-scale vaccination campaign should be continued.
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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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Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial.
Kosiborod, MN, Esterline, R, Furtado, RHM, Oscarsson, J, Gasparyan, SB, Koch, GG, Martinez, F, Mukhtar, O, Verma, S, Chopra, V, et al
The lancet. Diabetes & endocrinology. 2021;(9):586-594
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BACKGROUND COVID-19 can lead to multiorgan failure. Dapagliflozin, a SGLT2 inhibitor, has significant protective benefits for the heart and kidney. We aimed to see whether this agent might provide organ protection in patients with COVID-19 by affecting processes dysregulated during acute illness. METHODS DARE-19 was a randomised, double-blind, placebo-controlled trial of patients hospitalised with COVID-19 and with at least one cardiometabolic risk factor (ie, hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease). Patients critically ill at screening were excluded. Patients were randomly assigned 1:1 to dapagliflozin (10 mg daily orally) or matched placebo for 30 days. Dual primary outcomes were assessed in the intention-to-treat population: the outcome of prevention (time to new or worsened organ dysfunction or death), and the hierarchial composite outcome of recovery (change in clinical status by day 30). Safety outcomes, in patients who received at least one study medication dose, included serious adverse events, adverse events leading to discontinuation, and adverse events of interest. This study is registered with ClinicalTrials.gov, NCT04350593. FINDINGS Between April 22, 2020 and Jan 1, 2021, 1250 patients were randomly assigned with 625 in each group. The primary composite outcome of prevention showed organ dysfunction or death occurred in 70 patients (11·2%) in the dapagliflozin group, and 86 (13·8%) in the placebo group (hazard ratio [HR] 0·80, 95% CI 0·58-1·10; p=0·17). For the primary outcome of recovery, 547 patients (87·5%) in the dapagliflozin group and 532 (85·1%) in the placebo group showed clinical status improvement, although this was not statistically significant (win ratio 1·09, 95% CI 0·97-1·22; p=0·14). There were 41 deaths (6·6%) in the dapagliflozin group, and 54 (8·6%) in the placebo group (HR 0·77, 95% CI 0·52-1·16). Serious adverse events were reported in 65 (10·6%) of 613 patients treated with dapagliflozin and in 82 (13·3%) of 616 patients given the placebo. INTERPRETATION In patients with cardiometabolic risk factors who were hospitalised with COVID-19, treatment with dapagliflozin did not result in a statistically significant risk reduction in organ dysfunction or death, or improvement in clinical recovery, but was well tolerated. FUNDING AstraZeneca.
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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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Differences in Adolescents' Food Habits Checklist (AFHC) Scores before and during Pandemic in a Population-Based Sample: Polish Adolescents' COVID-19 Experience (PLACE-19) Study.
Skolmowska, D, Głąbska, D, Guzek, D
Nutrients. 2021;(5)
Abstract
The COVID-19 pandemic is known to influence the dietary habits of adults, but results for adolescents in studies are ambiguous. The present work aimed to analyze the differences in the scores of the Adolescents' Food Habits Checklist (AFHC) before and during the pandemic in the Polish Adolescents' COVID-19 Experience (PLACE-19) Study population. The PLACE-19 Study was conducted during the pandemic among a population of 2448 students recruited from secondary schools in all regions of Poland using a random quota sampling. The participants were required to complete an AFHC consisting of 23 items pertaining to food purchase, preparation, and consumption habits. Current habits (during the pandemic) and previous habits were assessed and scored separately. The total (p = 0.001), purchase (p < 0.001), and consumption scores (p = 0.014) indicated that the AFHC scores during the pandemic were higher than before. For questions on purchase habits, a lower number of respondents reported eating in a restaurant, eating takeaway meals, having lunch away from home, or buying pastries, cakes or crisps. For questions on preparation habits, an greater number of respondents reported that they usually avoided eating fried food and tried to keep their overall sugar intake down, but fewer respondents said they tried to have low-fat desserts. For questions on consumption habits, a lower number of respondents reported that they usually ate a dessert or pudding if one were available and a larger number said they made sure to eat at least one serving of vegetables or salad a day and at least three servings of fruit most days. Based on the obtained results, it may be stated that although there was an increase in the AFHC scores during the pandemic, a similar share of respondents showed improved or worsened food habits, and a similar share changed their food habits from healthy to unhealthy and from unhealthy to healthy. At the same time, a majority of changes were associated with purchase habits, which were probably forced by lockdowns and the resultant restrictions in eating out or grocery shopping.
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Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19.
Lasky, JA, Fuloria, J, Morrison, ME, Lanier, R, Naderer, O, Brundage, T, Melemed, A
Advances in therapy. 2021;(1):782-791
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INTRODUCTION The COVID-19 global pandemic caused by the novel coronavirus, SARS-CoV-2, and the consequent morbidity and mortality attributable to progressive hypoxemia and subsequent respiratory failure threaten to overrun hospital critical care units globally. New agents that address the hyperinflammatory "cytokine storm" and hypercoagulable pathology seen in these patients may be a promising approach to treat patients, minimize hospital stays, and ensure hospital wards and critical care units are able to operate effectively. Dociparstat sodium (DSTAT) is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, with the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding compared to commercially available heparin. METHODS This study is a randomized, double-blind, placebo-controlled, phase 2/3 trial to determine the safety and efficacy of DSTAT added to standard of care in hospitalized adults with COVID-19 who require supplemental oxygen. Phase 2 will enroll 12 participants in each of two dose-escalating cohorts to confirm the safety of DSTAT in this population. Following review of the data, an additional 50 participants will be enrolled. Contingent upon positive results, phase 3 will enroll approximately 450 participants randomized to DSTAT or placebo. The primary endpoint is the proportion of participants who survive and do not require mechanical ventilation through day 28. DISCUSSION Advances in standard of care, recent emergency use authorizations, and positive data with dexamethasone have likely contributed to an increasing proportion of patients who are surviving without the need for mechanical ventilation. Therefore, examining the time to improvement in the NIAID score will be essential to provide a measure of drug effect on recovery. Analysis of additional endpoints, including supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer), will be performed to further define the effect of DSTAT in patients with COVID-19 infection. TRIAL REGISTRATION ClinicalTrials.gov identifier; NCT04389840, Registered 13 May 2020.
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A pilot study on intravenous N-Acetylcysteine treatment in patients with mild-to-moderate COVID19-associated acute respiratory distress syndrome.
Taher, A, Lashgari, M, Sedighi, L, Rahimi-Bashar, F, Poorolajal, J, Mehrpooya, M
Pharmacological reports : PR. 2021;(6):1650-1659
Abstract
BACKGROUND We designed this single-centre clinical trial to assess the potential benefits of N-Acetylcysteine (NAC) in patients with COVID19-associated acute respiratory distress syndrome (ARDS). METHODS Ninety-two patients with mild-to-moderate COVID19-associated ARDS were allocated to the placebo (45-cases) or NAC groups (47-cases). Besides standard-of-care treatment, the patients received either intravenous NAC at a dose of 40 mg/kg/day or the placebo for three consecutive days. The efficacy outcomes were overall mortality over 28-day, clinical status on day 28, based on the WHO Master Protocol, the proportion of patients requiring mechanical ventilation, changes in ARDS-severity (based on the PaO2/FiO2 ratio), and Sequential Organ Failure Assessment (SOFA) scores 48 and 96 h after intervention, RESULTS No differences were found in the 28-day mortality rate between the two groups (25.5% vs. 31.1% in the NAC and placebo groups, respectively). Although the distribution of the clinical status at day 28 shifted towards better outcomes in the NAC-treated group, it did not reach a statistical significance level (p value = 0.83). Similar results were achieved in terms of the proportion of patients who required invasive ventilator support (38.3% vs. 44.4%), the number of ventilator-free days (17.4 vs. 16.6), and median time of ICU and hospital stay. Results regarding the change in PaO2/FiO2 ratio and SOFA scores also showed no significant differences between the groups. CONCLUSIONS Our pilot study did not support the potential benefits of intravenous NAC in treating patients with COVID-19-associated ARDS. More studies are needed to determine which COVID-19 patients benefit from the NAC administration. TRIAL REGISTRATION The trial was registered at Clinicaltrials.gov (identifier code: IRCT20120215009014N355). Registration date: 2020-05-18.
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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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Food Insecurity Prevalence, Severity and Determinants in Australian Households during the COVID-19 Pandemic from the Perspective of Women.
Kleve, S, Bennett, CJ, Davidson, ZE, Kellow, NJ, McCaffrey, TA, O'Reilly, S, Enticott, J, Moran, LJ, Harrison, CL, Teede, H, et al
Nutrients. 2021;(12)
Abstract
This study aimed to describe the prevalence, severity and socio-demographic predictors of food insecurity in Australian households during the COVID-19 pandemic in 2020, from the perspective of women. A cross-sectional online survey of Australian (18-50 years) women was conducted. The survey collected demographic information and utilised the 18-item US Department of Agriculture Household Food Security Survey Module and the Kessler Psychological Distress Scale (K10). A multivariable regression was used to identify predictors of food security status. In this cohort (n = 1005), 19.6% were living in households experiencing food insecurity; with 11.8% experiencing low food-security and 7.8% very low food-security. A further 13.7% of households reported marginal food-security. Poor mental health status (K10 score ≥ 20) predicted household food insecurity at all levels. The presence of more than three children in the household was associated with low food-security (OR 6.24, 95% CI: 2.59-15.03). Those who were renting were 2.10 (95% CI: 1.09-4.05) times likely to experience very low food-security than those owning their own home. The COVID-19 pandemic may have contributed to an increased prevalence of household food insecurity. This study supports the need for a range of responses that address mental health, financial, employment and housing support to food security in Australia.