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Objectives: To describe and compare real-world outcomes for patients with mild-to-moderate COVID-19 at high risk for progression to severe COVID-19, treated with sotrovimab versus untreated. Method(s): Electronic health records from the National COVID Cohort Collaborative were used to identify US patients (aged >=12 years) diagnosed with COVID-19 (positive test or ICD-10: U07.1) in an ambulatory setting (26 May 2021-30 April 2022) who met Emergency Use Authorization high-risk criteria. Patients receiving the monoclonal antibody (mAb) sotrovimab within 10 days of diagnosis were assigned to the sotrovimab cohort with an index date on the day of infusion. Untreated patients (no evidence of early mAb treatment or prophylaxis mAb or oral antiviral treatment) were assigned to the untreated cohort with an imputed index date based on the time distribution between diagnosis and sotrovimab infusion for the sotrovimab cohort. The primary endpoint was hospitalization or death (both all-cause) within 29 days of index, reported as descriptive rates and adjusted (via inverse-probability-of-treatment weighting [IPTW]) odds ratios (OR) and 95% confidence intervals (CI). Result(s): Of nearly 2.9 million patients diagnosed with COVID-19 during the analysis time period, 4,992 met the criteria for the sotrovimab cohort and 541,325 were included in the untreated cohort. Patients in the sotrovimab cohort were older (60 versus 54 years), more likely to be male (40% versus 38%) and White (85% versus 75%), and met more EUA criteria (3 versus 2) versus the untreated cohort. The 29-day hospitalization or mortality rates were 3.5% (176/4,992) and 4.5% (24,163/541,325) in the sotrovimab and untreated cohorts respectively (unadjusted OR [95% CI]: 0.77 [0.67,0.90];p=0.001;IPTW-adjusted OR [95% CI]: 0.74 [0.61,0.91];p=0.004). Conclusion(s): Sotrovimab demonstrated clinical effectiveness in preventing severe outcomes (hospitalization, mortality) between 26 May 2021-30 April 2022, which included the Delta variant and early surge of Omicron BA.1/BA.2. Funding(s): GSK (Study 219020)Copyright © 2023
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The objective was to evaluate real-world effectiveness of sotrovimab, a monoclonal antibody (mAb) for the treatment of high-risk outpatients with COVID-19, in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. A retrospective analysis was conducted of de-identified, high-risk patients diagnosed with COVID-19 (index date) from 1 September 2021 to 28 February 2022 in the FAIR Health FH NPIC claims database. Patients were divided into 2 cohorts based on claimed procedural codes: treated with sotrovimab and not treated with any mAb (no mAb). Facility-reported mortality ("mortality"), all cause hospitalizations and intensive care unit (ICU) admissions <=30 days of index were identified. Multivariable logistic regression was conducted to estimate the risk of 30-day mortality or hospitalization, adjusting for demographic and clinical factors. Of the high-risk COVID-19 patients identified,13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, sotrovimab treatment was associated with 85% reduced odds of 30-day mortality (OR: 0.15, 95% CI: 0.08-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.44) among high-risk COVID-19 patients. In this US real-world study of high-risk COVID-19 patients during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
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Background. Sotrovimab, a monoclonal antibody (mAb), received Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with symptomatic COVID-19. The study objective was to evaluate real-world effectiveness of sotrovimab (500 mg intravenous) in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. Methods. A retrospective analysis was conducted of de-identified patients (pts) diagnosed with COVID-19 (ICD-10: U07.1) from 9/1/2021 to 2/28/2022 in the FAIR Health FH NPIC claims database. Pts were divided into 2 cohorts based on HCPCS codes: treated with sotrovimab and not treated with any mAb (no mAb). Pts meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records <= 24 months prior to their first COVID-19 diagnosis (index date). Facility-reported mortality (referred to as 'mortality'), all cause hospitalizations and intensive care unit (ICU) admissions within 30 days of index were identified. Chi-square test, ANOVA, or t-tests were performed to statistically compare cohorts at a 0.05 level of significance (2-sided). P-values were not adjusted for multiplicity. Multivariable logistic regression was conducted to estimate the risk of mortality or hospitalization within 30 days, adjusting for demographic and clinical factors. Results. Of the high-risk COVID-19 pts identified, 13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. Compared to the no mAb cohort, the sotrovimab cohort was older, had more baseline conditions, and were more likely to be female (all p < 0.0001). In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, treatment with sotrovimab was associated with 83% reduced odds of 30-day mortality (OR: 0.17, 95% CI: 0.09-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.43) among high-risk COVID-19 pts. Conclusion. In this US real-world observational study of high-risk COVID-19 pts during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
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Purpose: Peer support has been identified as an important protective factor for mental health and overall well-being. The purpose of this study is to examine the feasibility of implementing an online peer support group and its impact on measures of well-being. Design/methodology/approach: A mixed-methods randomized controlled trial design was used to examine the feasibility and impact of online peer support. Comparisons in well-being were made between the online peer support group and an in-person peer support group and control group. Participants were randomly assigned to a control group or either a six-week in-person or online peer support group. All participants completed an online survey measuring constructs of well-being pre- and post-condition. Additionally, qualitative data regarding the benefits of peer support and in particular the efficacy of the online format were collected from participants. Analysis of variance and post hoc tests determined significant differences within and between the groups. Findings: Both the online and face-to-face peer support groups scored significantly higher on post-test measures of well-being than pre-test scores and control group scores. Qualitative narratives and significant quantitative findings supported the feasibility of peer support offered online. Post-condition outcomes showed that online peer support is as effective as in-person peer support for improving well-being. Originality/value: To the best of the authors’ knowledge, this study is the first of its kind to compare online and in-person peer support programs for students in higher education. The results have direct implications for higher education students and practitioners, especially at times when face-to-face support is not feasible. © 2021, Emerald Publishing Limited.
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Purpose This study aims to examine Reddit posts regarding the COVID-19 pandemic from a subreddit dedicated to the campus community of a large, research-intensive Canadian University. The goal was to determine what users were sharing regarding their mental health, well-being, problems, coping strategies and perceptions about the health measures taken to prevent further spread. Design/methodology/approach A total of 1,096 paragraphs were analyzed using the qualitative methodology of thematic analysis. Findings Many users expressed struggling with their mental health and well-being during the pandemic. Difficulties with online learning, finding paid study and affording the costs of living were also reported. Coping was largely conducted through online means and included sharing advice, emphasizing connectedness and communicating information. The mixed perceptions regarding health measures focused on responsibility and fairness, with many users blaming the university and public health units. Originality/value This study contributes to the evolving understanding of how different populations are affected by the COVID-19 pandemic in Canada, specifically, university students. Implications for providing assistance to university students during the current pandemic and future waves are also discussed.