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1.
Drug Safety ; 45(10):1189-1190, 2022.
Article in English | EMBASE | ID: covidwho-2085641

ABSTRACT

Introduction: Sotrovimab is a monoclonal therapy authorized for emergency use (EUA) on May 26, 2021, by the US (FDA) for treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and children >= 12 years old). The drug showed positive viral testing in severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2) and, reduced risk for progressing to severe COVID-19, including hospitalization or death1. Objective(s): This paper reviewed published data on safety of Sotrovimab 500mg in COVID-19 patients. Method(s): The study based on reviewing published literature. Pubmed and FDA web was searched for data on Safety of Sotrovimab use in COVID-19 patients (May2021-May2022). Result(s): Gupta A et al2 reported among (n = 291 Sotrovimab group, n = 292 placebo group) mild diarrhea occurred in 5 cases (1%) in Sotrovimab group, compared to 1 case of moderate diarrhea, while diarrhea occurred in 3 patients in placebo group. One patient who received Sotrovimab had moderate dyspnea, an infusion-related reaction that was related to Sotrovimab. Hospitalization adverse events occurred in 2% of Sotrovimab group and in 6% in placebo group. No death or serious adverse events e.g., hematological disorders or liver damage were related to Sotrovimab. Further study by Gupta A et al3 for Sotrovimab (n = 528) or placebo (n = 529) reported that adverse events were infrequent and are similar between two groups (22% for Sotrovimab vs 23% for placebo);the most common events were diarrhea with Sotrovimab (n = 8;2%) and COVID-19 pneumonia with placebo (n = 22;4%). Kreuzberger N et al4 reported treatment with Sotrovimab may reduce the number of participants with oxygen requirement weaned in 3 days and risk of all-cause hospitalization or death without exhibiting significant adverse reaction. Fernandes G et al5 observed that following administration of Sotrovimab to kidney transplant recipients infected with Omicron variant, two patients required hospitalization for oxygen therapy. None were admitted to the intensive care unit or died. Conclusion(s): This review found limited number of safety studies of Sotrovimab in COVID-19, which reflects low numbers of publications. This is probably because of the Emergency utilization of drug and limitation of use in many countries. Lately, FDA US announced Sotrovimab is no longer authorized to treat COVID-19 in US due to increases in the proportion of COVID-19 cases caused by the Omicron variants6. Further data is needed to evaluate Sotrovimab safety in COVID-19 patients and examine risk-benefit, adverse events, and risk correlation to disease severity in patients with various risk factors.

2.
Studies in Systems, Decision and Control ; 216:607-616, 2023.
Article in English | Scopus | ID: covidwho-2075243

ABSTRACT

This study aimed to evaluating the students’ attitude toward the use of Moodle mobile application at Zarqa University (ZU) in the covid-19 pandemic. The study used the descriptive analytical approach, and the study sample consisted of (368) students who were randomly selected of undergraduate studies in ZU, and to achieve the objectives of the study, the researchers designed a questionnaire as a tool for collecting data from the members of the study sample. Among undergraduate students in Jordanian universities, There are statistically significant differences in the use of the mobile phone “Moodle mobile application” in distance learning for bachelor’s degree students at private Jordanian universities at the significance level (=0.05). This research focuses on the elements that influence students’ adoption of the Moodle mobile application and its ability to be used effectively. As a conceptual research framework of Moodle mobile application adoption, the technology acceptance model (TAM) is used. This paper aims to evaluate factors affecting the student’s attitude toward the use of the Moodle mobile application at Zarqa University (ZU) in Jordan. The following recommendations were made based on the findings of the study, which showed that students are interested in and satisfied with the Moodle mobile application: Encouraging faculty members and undergraduate students in Jordanian universities to use Moodle mobile application in teaching, design of educational technology lessons for undergraduate and postgraduate subjects to used it in teaching through the Moodle mobile application in order to achieve the goals of distance teaching. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

3.
Drug Safety ; 45(10):1189-1190, 2022.
Article in English | ProQuest Central | ID: covidwho-2045080

ABSTRACT

Introduction: Sotrovimab is a monoclonal therapy authorized for emergency use (EUA) on May 26, 2021, by the US (FDA) for treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and children > 12 years old). The drug showed positive viral testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and, reduced risk for progressing to severe COVID-19, including hospitalization or death1. Objective: This paper reviewed published data on safety of Sotrovimab 500mg in COVID-19 patients. Methods: The study based on reviewing published literature. Pubmed and FDA web was searched for data on Safety of Sotrovimab use in COVID-19 patients (May2021-May2022). Results: Gupta A et al2 reported among (n = 291 Sotrovimab group, n = 292 placebo group) mild diarrhea occurred in 5 cases (1%) in Sotrovimab group, compared to 1 case of moderate diarrhea, while diarrhea occurred in 3 patients in placebo group. One patient who received Sotrovimab had moderate dyspnea, an infusion-related reaction that was related to Sotrovimab. Hospitalization adverse events occurred in 2% of Sotrovimab group and in 6% in placebo group. No death or serious adverse events e.g., hematological disorders or liver damage were related to Sotrovimab. Further study by Gupta A et al3 for Sotrovimab (n = 528) or placebo (n = 529) reported that adverse events were infrequent and are similar between two groups (22% for Sotrovimab vs 23% for placebo);the most common events were diarrhea with Sotrovimab (n = 8;2%) and COVID-19 pneumonia with placebo (n = 22;4%). Kreuzberger N et al4 reported treatment with Sotrovimab may reduce the number of participants with oxygen requirement weaned in 3 days and risk of all-cause hospitalization or death without exhibiting significant adverse reaction. Fernandes G et al5 observed that following administration of Sotrovimab to kidney transplant recipients infected with Omicron variant, two patients required hospitalization for oxygen therapy. None were admitted to the intensive care unit or died. Conclusion: This review found limited number of safety studies of Sotrovimab in COVID-19, which reflects low numbers of publications. This is probably because of the Emergency utilization of drug and limitation of use in many countries. Lately, FDA US announced Sotrovimab is no longer authorized to treat COVID-19 in US due to increases in the proportion of COVID-19 cases caused by the Omicron variants6. Further data is needed to evaluate Sotrovimab safety in COVID-19 patients and examine risk-benefit, adverse events, and risk correlation to disease severity in patients with various risk factors.

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