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      Experience of the United Arab Emirates in the use of monoclonal antibody drug sotrovimab in high-risk vaccinated and unvaccinated patients with COVID-19: an observational cohort study

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          Abstract

          Objectives

          Monoclonal antibodies can slow COVID-19 progression. This study describes the experience of using sotrovimab in patients with COVID-19 at high risk for disease progression and hospitalisation within the United Arab Emirates (UAE).

          Design

          Observational cohort study.

          Setting

          A tertiary hospital in the Emirate of Sharjah, UAE.

          Participants

          Patients with mild or moderate COVID-19 at high risk for disease progression.

          Interventions

          Infusion with a single 500 mg dose of the monoclonal antibody drug sotrovimab.

          Primary and secondary outcome measures

          Any adverse effect within 24 hours, disease progression within 5 days, emergency department visit within 10 days, hospital admission within 10 days or mortality within 28 days of infusion.

          Results

          3227 high-risk COVID-19 patients were infused with sotrovimab during the mild (n=3107, 96.3%) or moderate (n=120, 3.7%) disease stages. The incidence of at least one outcome was recorded in 196 (6.1%) of the patients (60.7 per 1000 patients). The most common outcome was disease progression within 5 days of infusion in 129 patients (4.0%), followed by emergency department visits by 90 patients (2.8%) within 10 days. Twenty-nine (0.9%) patients were hospitalised within 10 days of infusion with only two deaths (0.1%). Patients infused with sotrovimab during the moderate disease stage had 11 times greater odds of developing at least one outcome compared with patients infused during the mild stage (adjusted OR, aOR 10.86, 95% CI 7.14 to 16.54). SARS-CoV-2 vaccinated (aOR 12.8, 95% CI 7.3 to 20.5) and unvaccinated (aOR 7.2, 95% CI 3.4 to 15.3) patients infused with sotrovimab during the moderate disease stage had similar odds of at least one outcome compared with patients infused during the mild stage.

          Conclusions

          Among high-risk sotrovimab-infused COVID-19 patients, there were relatively low incidences of disease progression and hospitalisation. Regardless of vaccination history, monoclonal antibody intervention during the early stages of COVID-19 results in better outcomes.

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          Most cited references17

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          Clinical Characteristics of Coronavirus Disease 2019 in China

          Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)
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            Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area

            There is limited information describing the presenting characteristics and outcomes of US patients requiring hospitalization for coronavirus disease 2019 (COVID-19).
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              Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

              Predictive models of immune protection from COVID-19 are urgently needed to identify correlates of protection to assist in the future deployment of vaccines. To address this, we analyzed the relationship between in vitro neutralization levels and the observed protection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using data from seven current vaccines and from convalescent cohorts. We estimated the neutralization level for 50% protection against detectable SARS-CoV-2 infection to be 20.2% of the mean convalescent level (95% confidence interval (CI) = 14.4-28.4%). The estimated neutralization level required for 50% protection from severe infection was significantly lower (3% of the mean convalescent level; 95% CI = 0.7-13%, P = 0.0004). Modeling of the decay of the neutralization titer over the first 250 d after immunization predicts that a significant loss in protection from SARS-CoV-2 infection will occur, although protection from severe disease should be largely retained. Neutralization titers against some SARS-CoV-2 variants of concern are reduced compared with the vaccine strain, and our model predicts the relationship between neutralization and efficacy against viral variants. Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                10 January 2023
                10 January 2023
                : 13
                : 1
                : e066095
                Affiliations
                [1 ]departmentDepartment of Pediatric Cardiology , Al Qassimi Hospital , Sharjah, UAE
                [2 ]departmentHospital department , Emirates Health Service , Dubai, UAE
                [3 ]departmentDepartment of Anesthesia and Critical Care Medicine , Al Qassimi Hospital , Sharjah, UAE
                [4 ]departmentAnesthesia department , University Hospital Sharjah , Sharjah, UAE
                [5 ]departmentDepartment of Medicine , Al Qassimi Hospital , Sharjah, UAE
                [6 ]departmentInstitute of Public Health, College of Medicine and Health Sciences , United Arab Emirates University , Al Ain, UAE
                [7 ]departmentZayed Center for Health Sciences, College of Medicine and Health Sciences , United Arab Emirates University , Al Ain, UAE
                Author notes
                [Correspondence to ] Dr Rami H. Al-Rifai; rrifai@ 123456uaeu.ac.ae
                Author information
                http://orcid.org/0000-0001-6102-0353
                Article
                bmjopen-2022-066095
                10.1136/bmjopen-2022-066095
                9835446
                36627160
                36e2f04a-c9d1-4eb5-afa4-71b1c6461cc5
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 28 June 2022
                : 12 December 2022
                Categories
                Infectious Diseases
                1506
                2474
                1706
                Original research
                Custom metadata
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                Medicine
                covid-19,public health,respiratory infections
                Medicine
                covid-19, public health, respiratory infections

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