Effectiveness and Safety of Regdanvimab in Patients With Mild-ToModerate COVID-19: A Retrospective Cohort Study

Background@#Regdanvimab has decreased the time to clinical recovery from coronavirus disease 2019 (COVID-19) and lowered the rate of oxygen therapy according to the results from phase 2/3 randomized controlled trial. More information is needed about the effects and safety of regdanvimab. @*Methods@#We analyzed data for patients with high-risk mild or moderate COVID-19 being admitted to Busan Medical Center between December 1, 2020 and April 16, 2021. A propensity score (PS) matched analysis was conducted to compare patients treated with and without regdanvimab. The primary outcome was in-hospital death or disease aggravation which means the need for oxygen therapy (low- or high-flow oxygen therapy and mechanical ventilation) and secondary outcomes comprised the length of hospital stay and adverse reactions. @*Results@#Among 1,617 selected patients, 970 (60.0%) were indicated for regdanvimab. Of these, 377 (38.9%) were administered with regdanvimab. Among a 1:1 PS-matched cohort of 377 patients each treated with and without regdanvimab, 19 (5%) and 81 (21.5%) reached the composite outcome of death, or disease aggravation, respectively (absolute risk difference, −16.4%; 95% confidence interval [CI], −21.1, −11.7; relative risk difference, 76.5%; P < 0.001).Regdanvimab significantly reduced the composite outcome of death, or disease aggravation in univariate (odds ratio [OR], 0.194; 95% CI, 0.112–0.320; P < 0.001) and multivariableadjusted analyses (OR, 0.169; 95% CI, 0.095–0.289; P < 0.001). The hospital stay was shorter for the group with than without regdanvimab. Some hematological adverse reactions were more frequent in the group without regdanvimab, but other adverse reactions did not significantly differ between the groups. @*Conclusion@#Regdanvimab was associated with a significantly lower risk of disease aggravation without increasing adverse reactions.

Effect of coronavirus disease 2019 on febrile children’s visits to the emergency department of a tertiary hospital

Purpose@#During the coronavirus disease 2019 pandemic, many countries have reported sharp drops in the numbers of patients, especially children, seeking emergency care unrelated to the disease. The author investigated the patterns of febrile children’s visits to the emergency department (ED) of a tertiary hospital from 2017 through 2020. @*Methods@#We compared the data of febrile children aged 15 years or younger who visited the ED in 2017-2019 and in 2020 (February through August, each year). Information on the children’s baseline characteristics, the Korean Triage and Acuity Scale 1-2 indicating a high severity, and ED disposition, such as hospitalization, were collected. In addition, we determined the number of children who underwent cancellation, defined as the leave of children without treatment, and the rates of respiratory virus polymerase chain reaction performance and its positivity. @*Results@#In 2020, we noted decreases in the median monthly fever-related ED visits (2017-2019, 326 [interquartile range, 292-425] vs. 2020, 149 [132-182]; P < 0.001) with a shorter median fever duration (2017-2019, 11 [3-27] days vs. 2020, 9 [2-23] days; P < 0.001). However, in the same year, we noted increases in rates of the Korean Triage and Acuity Scale 1-2 (2017-2019, 5.7% vs. 2020, 16.4%; P < 0.001) and hospitalization (2017-2019, 23.5% vs. 2020, 35.7%; P < 0.001). We also noted increases in the number of cancellation and the rate of respiratory virus polymerase chain reaction performance rate, along with a decrease in its positive rate in 2020. @*Conclusion@#During the pandemic, the febrile children’s visits to the ED decreased in number. However, the severity remarkably increased, requiring more medical attention.

Influenza Vaccine Effectiveness in Children at the Emergency Department during the 2018-2019 Season: the First Season School-aged Children Were Included in the Korean Influenza National Immunization Program

Background@#For the 2018–2019 season, the national influenza immunization program expanded to cover children aged from 6 months to 12 years in Korea. This study aimed to analyze vaccine effectiveness (VE) against influenza in children visiting the pediatric emergency room at a tertiary hospital during the 2018-2019 season. @*Methods@#Patients tested for influenza antigens from October 1st 2018 to May 31st 2019 at the pediatric emergency room of Samsung Medical Center were included. Patients' influenza antigen test results, influenza vaccination history, and underlying medical conditions were reviewed retrospectively. VE was estimated from the test-negative design study. @*Results@#Among the 2,901 visits with influenza test results 1,692 visits of 1,417 patients were included for analysis. Among these 1,417 patients, 285 (20.1%) were positive (influenza A, n = 211, 74.0%; influenza B, n = 74, 26.0%). The VE in all patients was 36.4% (95% confidence interval [CI], 13.9 to 53.1). The VE for influenza A was 37.6% (95% CI, 12.6 to 55.5) and VE for influenza B was 24.0% (−38.5 to 58.3). The VE in the age group 6 months to 12 years was significant with a value of 35.6% (95% CI, 10.5 to 53.7); it was not statistically significant in the age group 13 to 18 years. In a multivariate logistic regression model, patients who received an influenza vaccination were less likely to get influenza infection (OR, 0.6; 95% CI, 0.4 to 0.8; P = 0.001), with significant confounding factors such as age group 13 to 18 years (OR, 0.5; 95% CI, 0.3 to 0.8; P = 0.003) and underlying hematology-oncology disease (OR, 0.3;95% CI, 0.1 to 0.6; P = 0.002). @*Conclusion@#We report moderate effectiveness of influenza vaccination in previously healthy children aged from 6 months to 12 years in the 2018-2019 season.

Effect of coronavirus disease 2019 on febrile children’s visits to the emergency department of a tertiary hospital

Purpose@#During the coronavirus disease 2019 pandemic, many countries have reported sharp drops in the numbers of patients, especially children, seeking emergency care unrelated to the disease. The author investigated the patterns of febrile children’s visits to the emergency department (ED) of a tertiary hospital from 2017 through 2020. @*Methods@#We compared the data of febrile children aged 15 years or younger who visited the ED in 2017-2019 and in 2020 (February through August, each year). Information on the children’s baseline characteristics, the Korean Triage and Acuity Scale 1-2 indicating a high severity, and ED disposition, such as hospitalization, were collected. In addition, we determined the number of children who underwent cancellation, defined as the leave of children without treatment, and the rates of respiratory virus polymerase chain reaction performance and its positivity. @*Results@#In 2020, we noted decreases in the median monthly fever-related ED visits (2017-2019, 326 [interquartile range, 292-425] vs. 2020, 149 [132-182]; P < 0.001) with a shorter median fever duration (2017-2019, 11 [3-27] days vs. 2020, 9 [2-23] days; P < 0.001). However, in the same year, we noted increases in rates of the Korean Triage and Acuity Scale 1-2 (2017-2019, 5.7% vs. 2020, 16.4%; P < 0.001) and hospitalization (2017-2019, 23.5% vs. 2020, 35.7%; P < 0.001). We also noted increases in the number of cancellation and the rate of respiratory virus polymerase chain reaction performance rate, along with a decrease in its positive rate in 2020. @*Conclusion@#During the pandemic, the febrile children’s visits to the ED decreased in number. However, the severity remarkably increased, requiring more medical attention.

Influenza Vaccine Effectiveness in Children at the Emergency Department during the 2018-2019 Season: the First Season School-aged Children Were Included in the Korean Influenza National Immunization Program

Background@#For the 2018–2019 season, the national influenza immunization program expanded to cover children aged from 6 months to 12 years in Korea. This study aimed to analyze vaccine effectiveness (VE) against influenza in children visiting the pediatric emergency room at a tertiary hospital during the 2018-2019 season. @*Methods@#Patients tested for influenza antigens from October 1st 2018 to May 31st 2019 at the pediatric emergency room of Samsung Medical Center were included. Patients' influenza antigen test results, influenza vaccination history, and underlying medical conditions were reviewed retrospectively. VE was estimated from the test-negative design study. @*Results@#Among the 2,901 visits with influenza test results 1,692 visits of 1,417 patients were included for analysis. Among these 1,417 patients, 285 (20.1%) were positive (influenza A, n = 211, 74.0%; influenza B, n = 74, 26.0%). The VE in all patients was 36.4% (95% confidence interval [CI], 13.9 to 53.1). The VE for influenza A was 37.6% (95% CI, 12.6 to 55.5) and VE for influenza B was 24.0% (−38.5 to 58.3). The VE in the age group 6 months to 12 years was significant with a value of 35.6% (95% CI, 10.5 to 53.7); it was not statistically significant in the age group 13 to 18 years. In a multivariate logistic regression model, patients who received an influenza vaccination were less likely to get influenza infection (OR, 0.6; 95% CI, 0.4 to 0.8; P = 0.001), with significant confounding factors such as age group 13 to 18 years (OR, 0.5; 95% CI, 0.3 to 0.8; P = 0.003) and underlying hematology-oncology disease (OR, 0.3;95% CI, 0.1 to 0.6; P = 0.002). @*Conclusion@#We report moderate effectiveness of influenza vaccination in previously healthy children aged from 6 months to 12 years in the 2018-2019 season.

Clinical features of adolescents who visited the emergency department with chest discomfort: the importance of recognizing underlying medical conditions

Purpose@#We aimed to evaluate the clinical features of adolescents who visit emergency departments (EDs) with chest discomfort, and analyze the implications of underlying medical conditions for the development of cardiogenic chest discomfort. @*Methods@#We reviewed the medical records of adolescents (13-18 years) with chest discomfort who visited a tertiary hospital ED in Seoul, Korea from 2014 through 2018. Sex, age, duration and character of the discomfort, symptoms and signs, ED length of stay, abnormal findings of vital signs, chest radiograph, electrocardiogram, and elevated concentrations of cardiac enzymes were reviewed. Final diagnosis was based on cardiac evaluations within 1 year after the index visit. Underlying medical conditions were defined as visits to the cardiology, pulmonology or hematology-oncology clinics at least twice in the preceding year. Initial suspicious clinical findings were defined as palpitation, syncope or high blood pressure. Logistic regression was used to identify predictors for cardiac etiology. @*Results@#Of the 231 patients, 43 (18.6%) and 69 (29.9%) had underlying medical conditions and initial suspicious clinical findings, respectively. The predictors for cardiac etiology were underlying medical conditions (odds ratio, 4.28; 95% confidence interval, 1.09-16.73), initial suspicious clinical findings (4.77; 1.36-16.77), abnormal electrocardiogram (11.54; 3.22-41.32), and elevated concentration of troponin I (66.52; 5.37-823.55). The patients with cardiogenic chest discomfort had a longer median ED length of stay (281.0 minutes [interquartile range, 215.5-369.0] vs. 199.5 [132.8-298.0]; P = 0.004) and a higher hospitalization rate (48.3% vs. 13.4%; P < 0.001) than those with non-cardiogenic chest discomfort. @*Conclusion@#It may be necessary to recognize underlying medical conditions and initial suspicious clinical findings in EDs prior to cardiac evaluation in adolescents with chest discomfort.

Clinical features of adolescents who visited the emergency department with chest discomfort: the importance of recognizing underlying medical conditions

Purpose@#We aimed to evaluate the clinical features of adolescents who visit emergency departments (EDs) with chest discomfort, and analyze the implications of underlying medical conditions for the development of cardiogenic chest discomfort. @*Methods@#We reviewed the medical records of adolescents (13-18 years) with chest discomfort who visited a tertiary hospital ED in Seoul, Korea from 2014 through 2018. Sex, age, duration and character of the discomfort, symptoms and signs, ED length of stay, abnormal findings of vital signs, chest radiograph, electrocardiogram, and elevated concentrations of cardiac enzymes were reviewed. Final diagnosis was based on cardiac evaluations within 1 year after the index visit. Underlying medical conditions were defined as visits to the cardiology, pulmonology or hematology-oncology clinics at least twice in the preceding year. Initial suspicious clinical findings were defined as palpitation, syncope or high blood pressure. Logistic regression was used to identify predictors for cardiac etiology. @*Results@#Of the 231 patients, 43 (18.6%) and 69 (29.9%) had underlying medical conditions and initial suspicious clinical findings, respectively. The predictors for cardiac etiology were underlying medical conditions (odds ratio, 4.28; 95% confidence interval, 1.09-16.73), initial suspicious clinical findings (4.77; 1.36-16.77), abnormal electrocardiogram (11.54; 3.22-41.32), and elevated concentration of troponin I (66.52; 5.37-823.55). The patients with cardiogenic chest discomfort had a longer median ED length of stay (281.0 minutes [interquartile range, 215.5-369.0] vs. 199.5 [132.8-298.0]; P = 0.004) and a higher hospitalization rate (48.3% vs. 13.4%; P < 0.001) than those with non-cardiogenic chest discomfort. @*Conclusion@#It may be necessary to recognize underlying medical conditions and initial suspicious clinical findings in EDs prior to cardiac evaluation in adolescents with chest discomfort.

Current State and Future Improvement of the Elderly Participation in Clinical Trials

BACKGROUND: Clinical trials are widely used to approve the efficacy and discover adverse reactions of new drugs. However, there has been much concern about the unjustified exclusion of the older adults in clinical trials. The purpose of this study was to assess ageism in clinical trials and to find solution to any discovered discrimination. METHODS: An online questionnaire was completed by 1,650 experts including doctors, pharmaceutical staff, and contract research organization members. An offline inquiry was conducted by 250 experienced professors from a single tertiary hospital and other allied professions. The questions covered the current state of elderly participation, possible reasons for under-representation, and plans for its solution. RESULTS: Among 1,900 subjects, 246 (12.9%) individuals completed the survey. We excluded the six subjects who did not answer more than 10 questions, and analyzed the remaining 240 respondents. They agreed that there are tendencies to exclude the aged from clinical trials (69.2%), and that under-representation would cause difficulties for doctors and geriatric patients. Most people (84.6%) thought that treating older adults with the results from trials which exclude aged participants is inappropriate. Because respondents had difficulties explaining the trial process and obtaining informed consent, they thought establishing a geriatric clinical trial team would be highly effective. Experts also believed that financial inducements and legal regulations are required to increase elderly enrollment. CONCLUSION: Because the elderly have a unique physiology, the participation of older adults in clinical research is indispensable for verifying efficacy and determining potential adverse reactions. Consequently, clinical research professionals should be concerned about the participation of older subjects, and the authorities must begin to care about age discrimination in research fields.

Prevalence of Immediate-Type Food Allergy in Early Childhood in Seoul

PURPOSE: There are scanty epidemiologic data on the prevalence of food allergy (FA) among preschool children in Asia. We performed this study to determine the prevalence and causative foods of immediate-type FA in early childhood in Korea. METHODS: A questionnaire-based, cross-sectional study was performed between September and October 2011. Children aged 0-6 years were recruited from 301 public child care centers in Seoul. Parents were asked to complete a questionnaire on FA. Children with FA were classified into "perceived FA, ever," "immediate-type FA, ever," and "immediate-type FA, current" according to the algorithm. RESULTS: A total of 16,749 children were included in this study. The prevalence of "perceived FA, ever," "immediate-type FA, ever," and "immediate-type FA, current" was 15.1%, 7.0%, and 3.7%, respectively. "Immediate-type FA, current" was reported by 182 (4.9%) out of 3,738 children aged < or =2 years, 262 (3.4%) of 7,648 children aged 3-4 years, and 177 (3.3%) of 5,363 children aged 5-6 years. Hen's egg (126/621) was the most frequent cause as the individual food item, followed by cow's milk (82/621) and peanut (58/621). Among the food groups, fruits (114/621), tree nuts (90/621) and crustaceans (85/621) were the most common offending foods. The three leading causes of food-induced anaphylaxis were hen's egg (22/47), cow's milk (15/47), and peanut (14/47). CONCLUSIONS: The prevalence of immediate-type FA in early childhood is 3.7%, and is higher in younger children. The most common offending foods differed with age.

Positive conversion of specific IgE against house dust mite in children with atopic dermatitis under 24 months of age

PURPOSE: A considerable number of children with atopic dermatitis (AD) is known to be sensitized with respiratory allergen and developed to respiratory allergic disease. We aimed to determine the time of sensitization to house dust mite (HDM) allergen and identify the risk factors of sensitization in children with AD. METHODS: Data from 159 children with AD aged less than 24 months and with no sensitization to HDM were analyzed retrospectively. Disease severity, total IgE, specific IgE levels to HDM and food allergens were assessed. They were followed to monitor positive conversion of specific IgE against HDM and development of allergic respiratory diseases. The specific IgE was considered as positive when its level was over 0.69 kU/L. RESULTS: The 44.7% of children with AD were sensitized to HDM. The 50% of sensitization to HDM occurred at the median age of 52 months using survival analysis. The severity of atopic dermatitis (six area, six sign in atopic dermatitis score>15; hazard ratio, 2.62) and high peak total IgE in 2 years old (hazard ratio, 1.58) was associated with an increased risk of sensitization to HDM. Sensitization to food allergen, family history of allergic disease and total IgE of 1st visit of hospital were not associated with early sensitization to HDM. CONCLUSION: The sensitization of HDM of children with AD occurred at the median age of 52 months. The risk factors of sensitization to HDM were AD severity and total IgE level. Children with severe AD need to control the indoor environment before 24 months of age.