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1.
Annals of the Rheumatic Diseases ; 81:590, 2022.
Article in English | EMBASE | ID: covidwho-2008867

ABSTRACT

Background: SB5, an adalimumab (ADL) biosimilar, was developed in a low-concentration (40 mg/0.8 mL, SB5-LC) aligned with the reference ADL product. Pharmacokinetics (PK) equivalence of SB5 and reference ADL was demonstrated in a Phase I study conducted in healthy subjects1. Equivalent efficacy and comparable safety between 40 mg/0.8 mL SB5 and 40 mg/0.8 mL reference ADL were demonstrated in a Phase III study conducted in patients with rheumatoid arthritis2. High-concentration, low-volume, citrate-free SB5 (40 mg/0.4 mL, SB5-HC) has been developed as a part of life cycle management in line with the reference ADL formulation. Objectives: To compare the PK, safety, and tolerability of the newly developed SB5-HC (40 mg/0.4 mL) to prior SB5-LC (40 mg/0.8 mL) in healthy male subjects. Methods: This study was a randomised, single-blind, two-arm, parallel group, single-dose study in healthy male subjects. Subjects were randomised in a ratio of 1:1 to receive a single dose of either SB5-HC or SB5-LC by subcutaneous injection on Day 1 and then observed for 57 days during which the PK, safety, and immunogenicity were evaluated. The serum concentration of ADL was measured using an enzyme-linked immunosorbent assay. The primary PK parameters were area under the concentration-time curve from time zero to infnity (AUCinf) and maximum serum concentration (Cmax). Equivalence for the primary PK parameters was to be concluded if the 90% confdence intervals (CIs) for the ratio of geometric least squares means (LSMeans) of the treatment groups compared were completely contained within the pre-defned equivalence margin of 0.80 to 1.25 using an analysis of variance. Results: Of 188 randomised subjects, 187 subjects were analysed as PK Analysis Set (PKS) (n=93 in SB5-HC and n=94 in SB5-LC). One subject was excluded from the PKS in SB5-HC group (major protocol deviation for not being withdrawn in the event of confrmed COVID-19). The geometric LSMeans ratios for the comparison of SB5-HC and SB5-LC for AUCinf and Cmax were 0.920 and 0.984, respectively, and the corresponding 90% CIs were within the pre-defned equivalence margin of 0.80 to 1.25 (Table 1), indicating the two treatment groups are bioequivalent. There were no deaths, serious adverse events or discontinuation of the study due to treatment-emergent adverse events (TEAEs) during the study. The proportions of subjects who experienced TEAEs were comparable between the two treatment groups (44.7% in SB5-HC vs 51.1% in SB5-LC). The most frequent TEAEs were headache (10.6% in SB5-HC vs 12.8% in SB5-LC). Conclusion: This study demonstrated PK equivalence between SB5-HC and SB5-LC in healthy subjects. Both SB5-HC and SB5-LC were generally well tolerated with similar safety profiles.

2.
Online Learning ; 26(2):170-197, 2022.
Article in English | Web of Science | ID: covidwho-1894254

ABSTRACT

The COVID-19 pandemic caused universities worldwide to close campuses, forcing millions of teachers and students to resort to Emergency Remote Teaching (ERT) and learning. Though necessary, the sudden move to remote delivery marked a significant departure from the standards and norms in distance education. In Korea, the pandemic coincided with the start of the 2020 academic year. Though ERT was new and unplanned during the first semester of the year, it became Sustained Remote Teaching (SRT) in the second. Through the lens of performance improvement theory, we sought to determine if students' experiences and perceptions with learning remotely via SRT would change over time as a result of institutional preparedness and faculty support/experience. In total, 140 (Spring) and 93 (Fall) exchange students rated their perceptions of Teaching and Learning Processes, Student Support, and Course Structure with their ERT/SRT learning experiences via an electronic survey. An independent-samples one-way ANOVA indicated several statistically significant benchmarks, though results are interpreted as minor real world improvement. Implications for ERT/SRT policy and future research in the context of specific student groups are discussed.

3.
Journal of Social and Political Psychology ; 9(2):608-622, 2021.
Article in English | Web of Science | ID: covidwho-1702594

ABSTRACT

In counterfactual thinking, an imagined alternative to the reality that comprises an antecedent and a consequent is widely adopted in political discourse to justify past behaviors (i.e., counterfactual explanation) or to depict a better future (i.e., prefactual). However, they have not been properly addressed in political communication literature. Our study examines how politicians used counterfactual expressions for explanation of the past or preparation of the future during COVID-19, one of the most severe public health crises. All Congressional speeches of the Senate and House in the 116th Congress (2019-2020) were retrieved, and counterfactual expressions were identified along with time-focusing in each speech, using recent advances in natural language processing (NLP) techniques. The results show that counterfactuals were more practiced among Democrats in the Senate and Republicans in the House. With the spread of the pandemic, the use of counterfactuals decreased, maintaining a partisan gap in the House. However, it was nearly stable, with no party differences in the Senate. Implications of our findings are discussed, regarding party polarization, institutional constraints, and the quality of Congressional deliberation. Limitations and suggestions for future research are also provided.

4.
2021 IEEE International Conference on Consumer Electronics, ICCE 2021 ; 2021-January, 2021.
Article in English | Scopus | ID: covidwho-1247034

ABSTRACT

We propose a zero contact experiment environment like a living room at home using 'Internet of Things'-based light devices, display and smart-phone or tablet. For our experimental environment, we constructed a large room that has specific lighting systems on the ceiling. For providing a general look-and-feel of living room condition, we also prepared the room with neutral-colored wallpaper and placed the display in the room. Subjects and Experimenters can tap on buttons on the smart-phones or tablets for adjusting the illumination conditions and picture options of the display. Under various illumination conditions, subjects are asked to choose the best preferred picture mode set while watching ten kinds of test images. All these series of our experiments are conducted under no-contact experimental environment thanks to the wireless applications loaded onto the smart-phone, tablet and display. These applications: (i) collect the data;(ii) automatically build a dataset;(iii) analyze the data by using machine learning techniques. By employing our system, large datasets that contain participants' preferences for the given display under various illumination conditions are collected safely and easily without risking COVID-19 spread. As a result, after finishing our experiment, most participants, specifically color scientists, praised our zero-contact experimental solution which can be used for other perceptual experimental processes by providing an easy way to build and analyze databases. © 2021 IEEE.

5.
J Hosp Infect ; 106(3): 570-576, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-723894

ABSTRACT

BACKGROUND: Identifying the extent of environmental contamination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential for infection control and prevention. The extent of environmental contamination has not been fully investigated in the context of severe coronavirus disease (COVID-19) patients. AIM: To investigate environmental SARS-CoV-2 contamination in the isolation rooms of severe COVID-19 patients requiring mechanical ventilation or high-flow oxygen therapy. METHODS: Environmental swab samples and air samples were collected from the isolation rooms of three COVID-19 patients with severe pneumonia. Patients 1 and 2 received mechanical ventilation with a closed suction system, while patient 3 received high-flow oxygen therapy and non-invasive ventilation. Real-time reverse transcription-polymerase chain reaction (rRT-PCR) was used to detect SARS-CoV-2; viral cultures were performed for samples not negative on rRT-PCR. FINDINGS: Of the 48 swab samples collected in the rooms of patients 1 and 2, only samples from the outside surfaces of the endotracheal tubes tested positive for SARS-CoV-2 by rRT-PCR. However, in patient 3's room, 13 of the 28 environmental samples (fomites, fixed structures, and ventilation exit on the ceiling) showed positive results. Air samples were negative for SARS-CoV-2. Viable viruses were identified on the surface of the endotracheal tube of patient 1 and seven sites in patient 3's room. CONCLUSION: Environmental contamination of SARS-CoV-2 may be a route of viral transmission. However, it might be minimized when patients receive mechanical ventilation with a closed suction system. These findings can provide evidence for guidelines for the safe use of personal protective equipment.


Subject(s)
Coronavirus Infections/therapy , Decontamination/standards , Environmental Pollution/analysis , Hyperbaric Oxygenation/standards , Patients' Rooms/standards , Pneumonia, Viral/therapy , Pneumonia/therapy , Practice Guidelines as Topic , Respiration, Artificial/standards , Air Microbiology , COVID-19 , Humans , Pandemics
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