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      Sotrovimab in solid organ transplant recipients with COVID-19: a systematic review and meta-analysis

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          Abstract

          Background

          Despite widespread implementation of vaccination against coronavirus disease 2019 (COVID-19), solid organ transplant recipients (SOTRs) can remain particularly vulnerable to this disease. The present study was conducted to investigate the efficacy and safety of sotrovimab in the treatment of SOTRs with COVID-19.

          Methods

          A search was performed of PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar to gather relevant evidence through July 25, 2023. The quality of the included studies was assessed using the risk of bias tool. Comprehensive Meta-Analysis software (ver. 3.0, Biostat) was employed for data analysis.

          Results

          Ten studies, involving a total of 1,569 patients, were included. The meta-analysis revealed significant differences between the patients administered sotrovimab and those treated with the standard of care. These differences were observed in mortality rate (odds ratio [OR], 0.15; 95% confidence interval [CI], 0.03–0.67), hospitalization rate (OR, 0.35; 95% CI, 0.21–0.57), intensive care unit (ICU) admission rate (OR, 0.16; 95% CI, 0.04–0.62), the need for supplemental oxygen therapy (OR, 0.22; 95% CI, 0.09–0.51), and the need for mechanical ventilation (OR, 0.09; 95% CI, 0.01–0.70). However, no significant difference was observed between sotrovimab and other treatments regarding the rates of hospitalization or ICU admission (P>0.05). Regarding safety, sotrovimab was associated with a lower rate of adverse events compared to the absence of sotrovimab (OR, 0.15; 95% CI, 0.02–0.86).

          Conclusions

          These results suggest that sotrovimab may improve efficacy outcomes among SOTRs with COVID-19. Nevertheless, additional high-quality trials are necessary to confirm these findings.

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          Most cited references28

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          Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

          Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
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            ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

            Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomised Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
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              Real‐world experience with available, outpatient COVID‐19 therapies in solid organ transplant recipients during the omicron surge

              The SARS‐CoV‐2 pandemic continues to place a substantial burden on healthcare systems. Outpatient therapies for mild‐to‐moderate disease have reduced hospitalizations and deaths in clinical trials, but the real‐world effectiveness of monoclonal antibodies and oral antiviral agents in solid organ transplant recipients (SOTR) with coronavirus disease‐2019 (COVID‐19) is largely uncharacterized. We conducted a single‐center, retrospective review of 122 SOTR diagnosed with COVID‐19 in the outpatient setting during the Omicron surge to address this knowledge gap. The mean age was 54 years, 57% were males, and 67% were kidney transplant recipients. The mean time from transplant to COVID‐19 diagnosis was 75 months. Forty‐nine (40%) received molnupiravir, 24 (20%) received sotrovimab, and 1 (0.8%) received nirmatrelvir/ritonavir. No outpatient therapy was administered in 48 (39%). All 122 SOTR had >30 days follow‐up. Rates of hospitalization within 30 days of initiating therapy for molnupiravir, nirmatrelvir/ritonavir, and sotrovimab were 16% (8/49), 0% (0/1), and 8% (2/24), respectively, compared to 27% (13/48) in patients without outpatient therapy. There were no deaths in those who received any therapy versus 3 (6%) deaths in patients without outpatient therapy ( p  = .002). Overall, our experience suggests a role for monoclonal antibodies and oral antiviral agents in reducing COVID‐19‐related morbidity and mortality in SOTR.
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                Author and article information

                Journal
                Korean J Transplant
                Korean J Transplant
                Korean Journal of Transplantation
                The Korean Society for Transplantation
                2671-8790
                2671-8804
                31 December 2023
                3 November 2023
                3 November 2023
                : 37
                : 4
                : 277-285
                Affiliations
                [1 ]Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
                [2 ]Department of Biostatistics and Epidemiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
                [3 ]Department of Curative Affairs, Ministry of Health and Medical Education, Tehran, Iran
                Author notes
                Corresponding author: Bahman Amani Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Number 21, Dameshgh St., Vali-e Asr Ave., Tehran 1416753955, Iran, E-mail: b-amani@ 123456alumnus.tums.ac.ir
                Author information
                https://orcid.org/0000-0003-4298-1807
                https://orcid.org/0000-0003-4809-5662
                https://orcid.org/0000-0002-8057-8608
                https://orcid.org/0000-0002-2340-189X
                Article
                kjt-37-4-277
                10.4285/kjt.23.0038
                10772269
                37916433
                51d9e82c-eb87-4981-98f8-ba877690c50b
                Copyright © 2023 The Korean Society for Transplantation

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 10 July 2023
                : 13 September 2023
                : 26 September 2023
                Categories
                Original Article

                covid-19,sars-cov-2,organ transplantation
                covid-19, sars-cov-2, organ transplantation

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