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1.
BioDrugs ; 36(4): 431-436, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1930606

ABSTRACT

Biologics are increasingly vital medicines that significantly reduce morbidity as well as mortality, yet access continues to be an issue even in apparently wealthy countries, such as the USA. While patient access is expected to improve with the introduction of biosimilars, misperceptions in a significant part based on terminology continue to make a sustained contribution by biosimilars difficult. Patients are and will continue to suffer needlessly if biosimilars continue to be impugned. Consequently, it is increasingly urgent that semantics are clarified, and in particular, the implication that interchangeable biologics are better biosimilars dismissed. This paper distinguishes between the real differences between biologics that matter clinically to patients and discusses the actual meaning of a US Food and Drug Administration designation of interchangeability for a biosimilar product. This will help highlight where there is need for further Food and Drug Administration education and which stakeholders likely need that education the most.


Subject(s)
Biosimilar Pharmaceuticals , Biosimilar Pharmaceuticals/therapeutic use , Drug Approval , Humans , United States , United States Food and Drug Administration
2.
Viruses ; 14(5)2022 04 30.
Article in English | MEDLINE | ID: covidwho-1820415

ABSTRACT

Neutralizing antibody (NAb) detection is critical for evaluating herd immunity and monitoring the efficacy of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this study, quantitative SARS-CoV-2 antibody levels after vaccination were measured by chemiluminescent immunoassays, enzyme immunoassays, and surrogate virus neutralization tests (sVNTs), as well as plaque reduction neutralization tests (PRNT). Sequential blood samples were collected before and 1 and 3 months after vaccination in 30 healthy participants (two doses of Oxford-AstraZeneca [AZ] or Pfizer-BioNTech [BNT]). After vaccination, all sera tested positive for PRNT, with NAb titers ranging from 1:10 to 1:723. Median NAb titers were higher in the BNT vaccine group than in the AZ vaccine group at both one and three months post-vaccination. Excellent overall concordance rates were observed between serological assays and PRNT. In a quantitative correlation analysis, the results of sVNTs showed a strong correlation with those of PRNT. Results of the four binding antibody assays showed a significant correlation with those of PRNT. The serologic assays evaluated in this study could be used as sVNTs to evaluate the efficacy of SARS-CoV-2 vaccines.


Subject(s)
COVID-19 , Viral Envelope Proteins , Antibodies, Neutralizing , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunoassay , Membrane Glycoproteins , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Viral Envelope Proteins/metabolism
3.
HLA ; 100(1): 52-58, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1816658

ABSTRACT

The effects of COVID-19 vaccination on alloimmunization and clinical impact in transplant candidates remain largely unknown. In a 61-year-old man who had no donor-specific antibodies (DSA) and was planned to undergo ABO-incompatible kidney transplantation (ABOi KT), DSAs (anti-A24, anti-B51, and anti-Cw14) developed after COVID-19 vaccination. After desensitization therapy, antibody level was further increased, leading to flow cytometric crossmatch-positive status. Donor-specific T cell immunity using interferon-gamma ELISPOT was continuously negative, whereas SARS-CoV-2 specific T cell immunity was intact. After confirming the C1q-negative status of DSA, the patient received ABOi KT. The patient had stable graft function and suppressed alloimmunity up to 2 months after KT. COVID-19 vaccination might relate to alloimmunization in transplant candidates, and desensitization through immune monitoring can help guide transplantation.


Subject(s)
COVID-19 , Kidney Transplantation , Alleles , Antibodies , COVID-19 Vaccines , Flow Cytometry , Graft Rejection , Graft Survival , HLA Antigens , Humans , Living Donors , Male , Middle Aged , SARS-CoV-2 , Vaccination
4.
BMC Infect Dis ; 22(1): 330, 2022 Apr 04.
Article in English | MEDLINE | ID: covidwho-1775313

ABSTRACT

BACKGROUND: Respiratory infections among children, particularly community-acquired pneumonia (CAP), is a major disease with a high frequency among outpatient and inpatient visits. The causes of CAP vary depending on individual susceptibility, the epidemiological characteristics of the community, and the season. We performed this study to establish a nationwide surveillance network system and identify the causative agents for CAP and antibiotic resistance in Korean children with CAP. METHODS: The monitoring network was composed of 28 secondary and tertiary medical institutions. Upper and lower respiratory samples were assayed using a culture or polymerase chain reaction (PCR) from August 2018 to May 2020. RESULTS: A total of 1023 cases were registered in patients with CAP, and PCR of atypical pneumonia pathogens revealed 422 cases of M. pneumoniae (41.3%). Respiratory viruses showed a positivity rate of 65.7% by multiplex PCR test, and human rhinovirus was the most common virus, with 312 cases (30.5%). Two hundred sixty four cases (25.8%) were isolated by culture, including 131 cases of S. aureus (12.8%), 92 cases of S. pneumoniae (9%), and 20 cases of H. influenzae (2%). The cultured, isolated bacteria may be colonized pathogen. The proportion of co-detection was 49.2%. The rate of antibiotic resistance showed similar results as previous reports. CONCLUSIONS: This study will identify the pathogens that cause respiratory infections and analyze the current status of antibiotic resistance to provide scientific evidence for management policies of domestic respiratory infections. Additionally, in preparation for new epidemics, including COVID-19, monitoring respiratory infections in children and adolescents has become more important, and research on this topic should be continuously conducted in the future.


Subject(s)
COVID-19 , Community-Acquired Infections , Pneumonia, Mycoplasma , Adolescent , Child , Community-Acquired Infections/microbiology , Humans , Multiplex Polymerase Chain Reaction/methods , Staphylococcus aureus
5.
Schizophrenia (Heidelb) ; 8(1): 15, 2022 03 05.
Article in English | MEDLINE | ID: covidwho-1730292

ABSTRACT

This study compared the coronavirus disease 2019 (COVID-19)-related stress, fear of infection, loneliness, and depression between patients with schizophrenia and the general population. A face-to-face survey was administered to 1340 patients with a schizophrenia spectrum disorder and online survey of the general population (n = 2000) was conducted. The information gathered included the level of COVID-19-related stress, fear of infection, the Patient Health Questionnaire-9 score, and the three-item UCLA Loneliness Scale score. Structural equation modeling revealed a significant effect of fear of COVID-19 infection on depression among the general population and on loneliness among patients with schizophrenia. Loneliness experienced during COVID-19 exacerbated depression in both groups. In the COVID-19-related stress-loneliness-depression pathway, the partial mediating effect of loneliness was significant in both groups. Conversely, in the COVID-19-related fear-loneliness-depression pathway, the full mediating effect of loneliness was only significant in patients with schizophrenia. In conclusion, the loneliness associated with COVID-19-related stress and fear of infection was an important factor influencing depression, and the impact was greater in patients with schizophrenia compared with the general population. Thus, different mental health intervention plans are needed for patients with schizophrenia during the COVID-19 pandemic. During the long-lasting COVID-19 pandemic, social support and provision of mental health services to prevent loneliness and consequent depression are required in patients with schizophrenia.

6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-320185

ABSTRACT

Background: Respiratory infection in particular community acquired pneumonia (CAP) in children is a major disease that ranks high in outpatient and inpatient cases. The causes of CAP vary depending on the individual susceptibility, epidemiological characteristics of the community, and season. We performed this study to establish nationwide surveillance network system and identify the causative agents for CAP and antibiotics resistance in Korean children with CAP.. Methods: The monitoring network was composed of the 28 secondary and tertiary medical institutions. Upper and lower respiratory samples were assayed using culture or Polymerase chaini reaction (PCR) from Aug 2018 to May 2020. Results: A total of 1023 cases were registered in patients with CAP, and 264 cases (25.8%) were isolated by culture, S. aureus 131 cases (12.8%), S. pneumoniae 92 cases (9%), H. influenzae 20 cases (2%). PCR of atypical pneumonia pathogen revealed 422 cases of M. pneumoniae (41.3%). Respiratory virus showed positive rates in 65.7% by multiplex PCR test and of them, human rhinovirus was most highest with 312 cases (30.5%). The proportion of mixed infection was 49.2%. The rate of antibiotics resistance showed similar results as previous reports. Conclusions: It will identify the pathogens that cause respiratory infections, and analyze the current status of antibiotic resistance to provide scientific evidence for management policies of domestic respiratory infection. Also, in preparation for the new epidemic, including COVID19, monitoring of respiratory infections in children and adolescents, has become more important, and research should be continuously conducted in the future.

7.
Clin Ther ; 43(10): 1706-1727, 2021 10.
Article in English | MEDLINE | ID: covidwho-1525737

ABSTRACT

PURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies. METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or placebo. Primary objectives of both studies were safety and tolerability up to day 14 after infusion. Secondary end points included pharmacokinetic properties. Study 1.2 also measured virology and clinical efficacy. FINDINGS: Thirty-two individuals were randomized to study 1.1 (6 per CT-P59 dose cohort and 8 in the placebo cohort). By day 14 after infusion, adverse events (AEs) were reported in 2 individuals receiving CT-P59 20 mg/kg (headache and elevated C-reactive protein levels) and 1 receiving CT-P59 40 mg/kg (pyrexia) (all Common Terminology Criteria for Adverse Events grade 1). In study 1.2, 18 patients were randomized (5 per dose cohort and 3 in the placebo cohort). Sixteen AEs were reported in 10 patients receiving CT-P59. No AEs in either study led to study discontinuation. Greater reductions in viral titers were reported with CT-P59 than placebo in those with maximum titers >105 copies/mL. Mean time to recovery was 3.39 versus 5.25 days. IMPLICATIONS: CT-P59 exhibited a promising safety profile in healthy individuals and patients with mild SARS-CoV-2 infection, with potential antiviral and clinical efficacy in patients with mild SARS-CoV-2 infection. ClinicalTrials.gov identifier: NCT04525079 (study 1.1) and NCT04593641 (study 1.2).


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , Carrier Proteins , Double-Blind Method , Humans , Immunoglobulin G
8.
Journal for Advancement of Marketing Education ; 28(2):3-13, 2020.
Article in English | ProQuest Central | ID: covidwho-1498630

ABSTRACT

Purpose of the Study: This study highlights the value of teaching personal branding to university students and preparing them for the workforce. A conceptual model of the personal branding process is proposed utilizing Bandura's self-efficacy theory. We examine how student confidence in their personal brand management (personal brand management efficacy) and their ability to reference themselves and others as brands (personal brand belief concept) influence the authenticity of their personal brand, which impacts the self-actualization of students. Method/Design and Sample: Confirmatory factor analysis (CFA) and structural equation modeling (SEM) were used to analyze 117 undergraduate business student participant responses from a large university in the southeastern United States. Results: Personal brand concept belief and personal brand management efficacy positively influenced personal brand authenticity. Personal brand authenticity positively influenced self-actualization. Further, the effects of personal brand concept belief and personal brand management efficacy on self-actualization are mediated by personal brand authenticity. Value to Marketing Educators: As university graduates encounter competitive and volatile employment markets, educators can provide value through teaching personal branding strategies. Our results suggest personal branding has the potential to provide direction and advantages to students navigating the job search process. Academic programs can assist students in their personal branding through coursework, assignments, and interactions with industry professionals who have created their own successful brands.

9.
Clin Ther ; 43(10): 1706-1727, 2021 10.
Article in English | MEDLINE | ID: covidwho-1433085

ABSTRACT

PURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies. METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or placebo. Primary objectives of both studies were safety and tolerability up to day 14 after infusion. Secondary end points included pharmacokinetic properties. Study 1.2 also measured virology and clinical efficacy. FINDINGS: Thirty-two individuals were randomized to study 1.1 (6 per CT-P59 dose cohort and 8 in the placebo cohort). By day 14 after infusion, adverse events (AEs) were reported in 2 individuals receiving CT-P59 20 mg/kg (headache and elevated C-reactive protein levels) and 1 receiving CT-P59 40 mg/kg (pyrexia) (all Common Terminology Criteria for Adverse Events grade 1). In study 1.2, 18 patients were randomized (5 per dose cohort and 3 in the placebo cohort). Sixteen AEs were reported in 10 patients receiving CT-P59. No AEs in either study led to study discontinuation. Greater reductions in viral titers were reported with CT-P59 than placebo in those with maximum titers >105 copies/mL. Mean time to recovery was 3.39 versus 5.25 days. IMPLICATIONS: CT-P59 exhibited a promising safety profile in healthy individuals and patients with mild SARS-CoV-2 infection, with potential antiviral and clinical efficacy in patients with mild SARS-CoV-2 infection. ClinicalTrials.gov identifier: NCT04525079 (study 1.1) and NCT04593641 (study 1.2).


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , Carrier Proteins , Double-Blind Method , Humans , Immunoglobulin G
10.
Diagnostics (Basel) ; 11(8)2021 Aug 19.
Article in English | MEDLINE | ID: covidwho-1367801

ABSTRACT

Quantitative SARS-CoV-2 antibody assays against the spike (S) protein are useful for monitoring immune response after infection or vaccination. We compared the results of three chemiluminescent immunoassays (CLIAs) (Abbott, Roche, Siemens) and a surrogate virus neutralization test (sVNT, GenScript) using 191 sequential samples from 32 COVID-19 patients. All assays detected >90% of samples collected 14 days after symptom onset (Abbott 97.4%, Roche 96.2%, Siemens 92.3%, and GenScript 96.2%), and overall agreement among the four assays was 91.1% to 96.3%. When we assessed time-course antibody levels, the Abbott and Siemens assays showed higher levels in patients with severe disease (p < 0.05). Antibody levels from the three CLIAs were correlated (r = 0.763-0.885). However, Passing-Bablok regression analysis showed significant proportional differences between assays and converting results to binding antibody units (BAU)/mL still showed substantial bias. CLIAs had good performance in predicting sVNT positivity (Area Under the Curve (AUC), 0.959-0.987), with Abbott having the highest AUC value (p < 0.05). SARS-CoV-2 S protein antibody levels as assessed by the CLIAs were not interchangeable, but showed reliable performance for predicting sVNT results. Further standardization and harmonization of immunoassays might be helpful in monitoring immune status after COVID-19 infection or vaccination.

12.
Soc Sci Med ; 282: 114105, 2021 08.
Article in English | MEDLINE | ID: covidwho-1272726

ABSTRACT

During the first seven months of the COVID-19 pandemic, more than 175,000 crowdfunding campaigns were established in the US for coronavirus-related needs using the platform GoFundMe. Though charitable crowdfunding has been popular in recent years, the widespread creation of COVID-19 related campaigns points to potential shifts in how the platform is being used, and the volume of needs users have brought to the site during a profound economic, social, and epidemiological crisis. This study offers a systematic examination of the scope and impacts of COVID-19 related crowdfunding in the early months of the pandemic and assesses how existing social and health inequities shaped crowdfunding use and outcomes. Using data collected from all US-based GoFundMe campaigns mentioning COVID or coronavirus, we used descriptive analysis and a series of negative binomial and linear models to assess the contributions of demographic factors and COVID-19 impacts to campaign creation and outcome. We find significant evidence of growing inequalities in outcomes for campaigners. We find that crowdfunding provides substantially higher benefits in wealthier counties with higher levels of education. People from these areas are more likely to initiate campaigns in response to adverse health and economic impacts of COVID-19, and they also receive more funding compared to people living in areas with lower income and education. Modeling also indicates differential outcomes based on the racial and ethnic composition of county population, though without more detail about who is creating and funding campaigns we cannot explain causality. A targeted qualitative analysis of the top earning COVID-19 campaigns offers further evidence of how user privilege and corporate practices contribute to highly unequal outcomes. Taken together, these findings demonstrate how a market-oriented digital technology used to respond to large-scale crisis can exacerbate inequalities and further benefit already privileged groups.


Subject(s)
COVID-19 , Crowdsourcing , Humans , Pandemics , SARS-CoV-2
13.
Clin Hypertens ; 27(1): 11, 2021 Jun 01.
Article in English | MEDLINE | ID: covidwho-1249566

ABSTRACT

BACKGROUND: There have been concerns regarding the safety of renin-angiotensin-aldosterone-system (RAAS)-blocking agents including angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) during the coronavirus disease 2019 (COVID-19) pandemic. This study sought to evaluate the impact of hypertension and the use of ACEI/ARB on clinical severity in patients with COVID-19. METHODS: A total of 3,788 patients aged 30 years or older who were confirmed with COVID-19 with real time reverse transcription polymerase chain reaction were identified from a claims-based cohort in Korea. The primary study outcome was severe clinical events, a composite of intensive care unit admission, need for ventilator care, and death. RESULTS: Patients with hypertension (n = 1,190, 31.4 %) were older and had higher prevalence of comorbidities than those without hypertension. The risk of the primary study outcome was significantly higher in the hypertension group, even after multivariable adjustment (adjusted odds ratio [aOR], 1.67; 95 % confidence interval [CI], 1.04 to 2.69). Among 1,044 patients with hypertensive medical treatment, 782 (74.9 %) were on ACEI or ARB. The ACEI/ARB subgroup had a lower risk of severe clinical outcomes compared to the no ACEI/ARB group, but this did not remain significant after multivariable adjustment (aOR, 0.68; 95 % CI, 0.41 to 1.15). CONCLUSIONS: Patients with hypertension had worse COVID-19 outcomes than those without hypertension, while the use of RAAS-blocking agents was not associated with increased risk of any adverse study outcomes. The use of ACE inhibitors or ARBs did not increase the risk of adverse COVID-19 outcomes, supporting current guidance to continue these medications when indicated.

14.
Front Surg ; 7: 576196, 2020.
Article in English | MEDLINE | ID: covidwho-902455

ABSTRACT

Background: The coronavirus disease 2019 (COVID-19) outbreak in South Korea has affected the diagnosis, treatment, and follow-up protocols of various cancers. This study investigated the patterns of delaying surgery for breast cancer during the COVID-19 outbreak in South Korea and evaluated factors that may have affected the decision to delay surgery. Methods: From February 18 to April 18, 2020, which was the critical period for COVID-19 in South Korea, patients with breast cancer who were scheduled for surgery were evaluated in terms of their decision in delaying the procedure. The patients were divided into two groups: delaying and non-delaying surgery groups. The association between personal and clinicopathological factors and delaying surgery was evaluated. Results: In patients belonging to the delaying surgery group, the mean delay period was 15.9 (standard deviation [SD], ±10.9) days. Patients in the non-delaying surgery group were relatively younger (p = 0.003), single (p = 0.038), had planned mastectomy (p = 0.041), received needle biopsy for diagnosis (p = 0.021), and had a higher clinical N stage (p = 0.049) and multifocal lesions of breast cancer (p = 0.020). However, there were no significant differences in terms of the pathological T and N stages between the two groups. Conclusion: During the COVID-19 outbreak, there was no occurrence of nosocomial infection in the non-delaying surgery group and no statistical difference in pathological stage between the delaying and non-delaying surgery groups. Although patients in the delaying surgery group tended to be relatively older and married and had planned small-scale surgery with a good prognosis of breast cancer, the prognosis did not appear to have changed whether delaying or proceeding with surgery for breast cancer during the COVID-19 outbreak.

15.
Diabetes Metab J ; 44(5): 737-746, 2020 10.
Article in English | MEDLINE | ID: covidwho-895439

ABSTRACT

Background: Inconsistent results have been observed regarding the independent effect of diabetes on the severity of coronavirus disease 2019 (COVID-19). We conducted a nationwide population-based cohort study to evaluate the relationship between diabetes and COVID-19 severity in South Korea. METHODS: Patients with laboratory-confirmed COVID-19 aged ≥30 years were enrolled and medical claims data were obtained from the Korean Health Insurance Review and Assessment Service. Hospitalization, oxygen treatment, ventilator application, and mortality were assessed as severity outcomes. Multivariate logistic regression analyses were performed after adjusting for age, sex, and comorbidities. RESULTS: Of 5,307 COVID-19 patients, the mean age was 56.0±14.4 years, 2,043 (38.5%) were male, and 770 (14.5%) had diabetes. The number of patients who were hospitalized, who received oxygen, who required ventilator support, and who died was 4,986 (94.0%), 884 (16.7%), 121 (2.3%), and 211 (4.0%), respectively. The proportion of patients with diabetes in the abovementioned outcome groups was 14.7%, 28.1%, 41.3%, 44.6%, showing an increasing trend according to outcome severity. In multivariate analyses, diabetes was associated with worse outcomes, with an adjusted odds ratio (aOR) of 1.349 (95% confidence interval [CI], 1.099 to 1.656; P=0.004) for oxygen treatment, an aOR of 1.930 (95% CI, 1.276 to 2.915; P<0.001) for ventilator use, and an aOR of 2.659 (95% CI, 1.896 to 3.729; P<0.001) for mortality. CONCLUSION: Diabetes was associated with worse clinical outcomes in Korean patients with COVID-19, independent of other comorbidities. Therefore, patients with diabetes and COVID-19 should be treated with caution.


Subject(s)
Betacoronavirus/isolation & purification , Coronavirus Infections/epidemiology , Coronavirus Infections/mortality , Diabetes Mellitus/physiopathology , Hospitalization/statistics & numerical data , Pneumonia, Viral/epidemiology , Pneumonia, Viral/mortality , Severity of Illness Index , Adult , Aged , Aged, 80 and over , COVID-19 , Cohort Studies , Comorbidity , Coronavirus Infections/pathology , Coronavirus Infections/virology , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/pathology , Pneumonia, Viral/virology , Prognosis , Republic of Korea/epidemiology , SARS-CoV-2 , Survival Rate , Time Factors
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