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1.
Estudios de Deusto ; 70(2):191-224, 2022.
Article in Spanish | Scopus | ID: covidwho-2264018

ABSTRACT

The Sustainable Development Goals (SDGs) proclaimed by United Nations in 2015 are aimed at being the road map of the international community to achieve a necessary balance between economic growth, social justice, and the protection of the environment. Without a doubt, the fight against climate change is the most urgent goal in this uncertain beginning of a new century. In spite of some achievements, the truth is that the global pandemic of Covid-19, the war of aggression in Ukraine, and the climatic emergence are having devastating effects on SDGs. A renewed commitment and higher political will are necessary to meet the expectations of humankind. © Universidad de Deusto.

2.
NeuroQuantology ; 20(12):1832-1843, 2022.
Article in English | EMBASE | ID: covidwho-2091008

ABSTRACT

Consumers during this spread of the COVID-19 pandemic continue to believe in the concept of 'prevention is better than cure'. However, the preventive measure adopted varies from the traditional method where the latter resort to consuming healthy food in its original form and the earlier consumes so called healthy supplementary products that has intervention of new technology. Consumers lose clarity in understanding the method, composition, and components of health supplement items as the supplements sector expands with new inventions and advances in technology. This is made worse by deceiving marketing strategies adopted by the producer. The bold act of the producer in claiming that their product may cure serious diseases is not only unethical, but it is also a crime. Government of different jurisdictions adopts various monitoring measure to protect the rights of the consumer. In addressing this issue, this study aims at analysing the legal framework in selected jurisdictions that includes Singapore, Australia and United States of America with a view of identifying the best practices and proposing an effective legal framework. The study uses qualitative methods incorporating critical analysis on the legal framework of the selected jurisdiction. The area that is analysed consist of the accepted definition (to date this has become the main issue in regulating supplementary products), the registration process, the governing authority, and the post-registration monitoring. The analysis of data gathered through qualitative methods entails content analysis, which is supplemented by semi-structured interviews with respondents who were purposefully chosen. The findings to the study disclose the strength and weaknesses of the Malaysian legal framework that can be remedied by learning from the selected jurisdiction method. The output of this study may assist the government, policymaker, industry players and the consumer in reforming the protection of consumers to the supplementary products. Copyright © 2022, Anka Publishers. All rights reserved.

3.
BiLD Law Journal ; 7(1):1-9, 2022.
Article in English | Scopus | ID: covidwho-2083412

ABSTRACT

Dietary supplements hold a huge profit potential, according to the global health sector market. The number of supplements available to consumers has increased dramatically, owing to changes in consumer perceptions that supplements aid in the prevention of diseases. Consumers lose transparency in knowing the process, content, and components of dietary supplement products as the supplements sector expands with innovations and new technologies. They are exposed to a variety of concerns associated with dietary supplement items, including safety, efficacy, and quality. Malaysian consumer protection framework provides for resources of protection for the consumer. However, the lack of awareness of the consumer on the availability and actual functions of this platform for them to remedy their grudges and complaints would make the existing consumer protection framework nonfunctional and less efficient. The level of awareness may also contribute to the determination of the area of concern for the reformation of the recent consumer protection relating to the sales of dietary supplement products. Although dietary supplement market is not new, yet the transformation of this industry in adapting to the newly introduced technology and high dependency of the current consumer to the dietary supplement product calls for the need to reform the existing consumer protection framework. The study intends to analyse consumer awareness of dietary supplement products and the recent consumer protection framework in order to propose reforms to current consumer protection in this area. The study adopts a descriptive approach, data were collected through a pilot study that was conducted with 102 participants within Selangor and Kuala Lumpur. The questionnaires used the Likert scale and were distributed from January 2020 to December 2020 when the world is battling the COVÍD-19 attack. The questions were prepared in both languages, Malay Language and English Language to aid for better understanding on the part of the participants. The data were analysed using an online quantifying method to finalised the accurate percentage for each issue. The outputs were then described through analytical writing, tables and diagrams. © 2022 Bangladesh Institute of Legal Development. All Rights Reserved.

5.
Topics in Antiviral Medicine ; 30(1 SUPPL):40-41, 2022.
Article in English | EMBASE | ID: covidwho-1880656

ABSTRACT

Background:A previous report showed that a single 1200 mg subcutaneous (SC) dose of casirivimab and imdevimab (cas/imd) prevented symptomatic COVID-19 by 81.4% and reduced all SARS-CoV-2 infections (symptomatic and asymptomatic) by 66.4% in household contacts living with recently infected individuals over a 28-day period. While highly effective vaccines now exist for the prevention of COVID-19, a significant unmet need remains in patients who are unable to mount or maintain an adequate immune response to vaccination. Here we present additional results from 7-month follow-up period of the aforementioned study. Methods: In this randomized, double-blind, placebo-controlled Phase III trial, asymptomatic participants exposed to a SARS-CoV-2-infected household member were randomized 1:1 to a single SC dose of placebo or 1200 mg cas/imd (600 mg of each monoclonal antibody). Efficacy analyses include participants who were RT-qPCR negative for SARS-CoV-2 (no current infection) and seronegative for SARS-CoV-2 (no prior infection) at baseline. The trial consisted of a primary efficacy assessment period of 28 days (Month 1) and a 7-month follow-up period (Months 2-8). Results: Results from 842 placebo and 841 cas/imd RT-qPCR negative/seronegative enrolled participants (data through 04Oct2021, prior to emergence of Omicron) are presented. During the entirety of the 8-month study, cas/imd reduced the risk of symptomatic SARS-CoV-2 infections by 81.2% versus placebo (nominal P<0.0001;Table) and all SARS-CoV-2 infections (symptomatic and asymptomatic) by 68.2% versus placebo (nominal P<0.0001;Table). During Months 2-5, the risk of symptomatic and all infections were reduced by 100% and 89.5%, respectively (nominal P<0.0001). During Months 6-8 there was a resumption of symptomatic and all SARS-CoV-2 infections in the cas/imd group (19.9%;nominal P=0.6411 and 30.7%;nominal P=0.3967 risk reduction, respectively). Fewer cas/imd participants had a medically-attended visit versus placebo during the 8-months (1/841 [0.1%] vs 16/842 [1.9%], respectively). No new safety signals were identified for cas/imd during the follow-up period. Conclusion: During the 8-month study period, a 1200 mg SC dose of cas/imd prevented SARS-CoV-2 infections, with maximal protection through Month 5. The prolonged protection supports the use of cas/imd for the long-term prevention of COVID-19 against susceptible variants, offering a pre-exposure prophylaxis strategy for individuals who are unlikely to respond or be protected by vaccination.

6.
Pediatr Nephrol ; 36(10): 3109-3110, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1427251
7.
Topics in Antiviral Medicine ; 29(1):33-34, 2021.
Article in English | EMBASE | ID: covidwho-1250547

ABSTRACT

Background: Passive immunization has a long history for infection prevention following exposure. We report results of a descriptive interim analysis from a study of an antibody “cocktail” of casirivimab with imdevimab (cas/imdev;formerly REGN-COV2) designed to bind non-competing epitopes of the viral spike protein, as a potential passive vaccine for the prevention of COVID-19 in people at risk of infection from household contact. Methods: In this ongoing Phase 3 study, asymptomatic participants exposed to a COVID-19-infected household member were randomized 1:1 to placebo or 1200 mg cas/imdev (600 mg of each antibody administered subcutaneously) within 96 hours of their household member testing positive. The analysis included participants who tested negative for SARS-CoV-2 by nasal, saliva, or nasopharyngeal swab and who were seronegative to SARS-CoV-2 antibodies at baseline. The proportion of participants who developed an RT-PCR-confirmed SARS-CoV-2 infection (asymptomatic or symptomatic) during the 1-month efficacy assessment period was summarized. Results: Initial results from the first evaluable 223 placebo and 186 cas/imdev participants who completed ≥29 days of the study are reported. Reduction in PCR-positive symptomatic disease was 100% (0/186 cas/imdev vs 8/223 placebo;OR 0.00 [CI 0.00, 0.69]). Reduction in any PCR-positive infection (symptomatic or asymptomatic) was 48% (10/186 vs 23/223;OR 0.49 [CI 0.20, 1.12]). Placebo-group participants had on average 100-fold higher peak viral load. In the cas/imdev group, viral RNA was not detected for longer than 1 week but was detected for 3-4 weeks in approximately 40% of placebo participants (Fig. 1). The proportions of infected participants with high viral loads (>10 4 copies/mL) were 13/21 placebo vs 0/9 cas/imdev. Total weeks of viral RNA detection and high viral load were 44 and 22 weeks in the placebo group vs 9 and 0 in the cas/imdev group. Total symptomatic weeks were 21 for placebo vs 0 for cas/imdev. A similar proportion of participants experienced at least 1 serious adverse event: placebo, 3/222 and cas/imdev, 1/186;none were deemed related to study treatment. Injection site reactions were similar: placebo, 1.4%;cas/ imdev, 2.6%. Conclusion: In this descriptive interim analysis of participants at risk of SARSCoV- 2 infection from household transmission, a subcutaneous dose of the cas/ imdev antibody cocktail prevented symptomatic infection, reduced overall infection, and decreased viral load and duration of viral RNA detection.

8.
Pediatr Transplant ; 25(4): e14013, 2021 06.
Article in English | MEDLINE | ID: covidwho-1153582

ABSTRACT

The negative impact of COVID-19 on adults with underlying chronic kidney disease, including kidney transplant recipients, has been well documented. Children have a less severe presentation and better prognosis compared to adults. However, little is known regarding the spectrum of COVID-19 infection in children and adolescents with underlying autoimmune disorders necessitating solid organ transplant and long-term immunosuppressive therapy. Case Report. An adolescent male developed end-stage kidney disease secondary to microscopic polyangiitis requiring a living-donor kidney transplant. Six years later, he developed antibody-mediated rejection of his kidney transplant. During his rejection treatment course, he contracted SARS-CoV-2 and developed new-onset nephrotic syndrome with severe acute kidney injury. Kidney transplant biopsy revealed de novo collapsing focal segmental glomerulosclerosis on a background of chronic active antibody mediated rejection. Immunostaining for SARS-CoV-2 on the biopsy specimen demonstrated positive staining of the proximal tubular epithelium consistent with intra-renal viral infection. Pulse corticosteroids, intravenous immunoglobulin, and temporary reduction of anti-metabolite therapy resulted in successful recovery with return of graft function back to pre-infection baseline. This case highlights the clinical conundrum of treating kidney transplant recipients with active rejection in the midst of the COVID-19 pandemic. Pediatric kidney transplant recipients can develop severe COVID-19-related kidney complications. Judicious immunosuppression modulation is necessary to balance infection and rejection risk.


Subject(s)
COVID-19/complications , Glomerulosclerosis, Focal Segmental/etiology , Kidney Transplantation , Postoperative Complications/etiology , Adolescent , Humans , Male
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