{"id":21481,"date":"2022-06-04T04:54:00","date_gmt":"2022-06-03T20:54:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21481"},"modified":"2022-06-04T17:03:52","modified_gmt":"2022-06-04T09:03:52","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e5%8d%95%e5%85%8b%e9%9a%86%e6%8a%97%e4%bd%93sotrovimab%e5%af%b9%e8%bd%bb%e4%b8%ad%e5%ba%a6%e6%96%b0%e5%86%a0","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21481","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u65b0\u51a0\u75c5\u6bd2\u5355\u514b\u9686\u6297\u4f53Sotrovimab\u5bf9\u8f7b\u4e2d\u5ea6\u65b0\u51a0\u80ba\u708e\u9ad8\u5371\u60a3\u8005\u4f4f\u9662\u6216\u6b7b\u4ea1\u7684\u5f71\u54cd"},"content":{"rendered":"\n

Original Investigation March 14, 2022<\/p>\n\n\n\n

Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial<\/h1>\n\n\n\n

Anil\u00a0Gupta,\u00a0Yaneicy\u00a0Gonzalez-Rojas,\u00a0Erick\u00a0Juarez,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online March 14, 2022. doi:10.1001\/jama.2022.2832<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Among patients at risk of disease progression, does early treatment of mild to moderate COVID-19 with the neutralizing antibody sotrovimab prevent progression to severe disease?<\/p>\n\n\n\n

Findings<\/strong>  In this randomized clinical trial of 1057 participants, treatment with a single intravenous dose of sotrovimab, compared with placebo, resulted in a statistically significant reduction in the proportion of patients who experienced a composite outcome of all-cause hospitalization lasting longer than 24 hours or death through day 29 (1% vs 6%, respectively; adjusted relative risk, 0.21).<\/p>\n\n\n\n

Meaning<\/strong>  Findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown.<\/a>Abstract<\/p>\n\n\n\n

Importance<\/strong>  Older patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression.<\/p>\n\n\n\n

Objective<\/strong>  To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  Randomized clinical trial including 1057 nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for progression conducted at 57 sites in Brazil, Canada, Peru, Spain, and the US from August 27, 2020, through March 11, 2021; follow-up data were collected through April 8, 2021.<\/p>\n\n\n\n

Interventions<\/strong>  Patients were randomized (1:1) to an intravenous infusion with 500 mg of sotrovimab (n\u2009=\u2009528) or placebo (n\u2009=\u2009529).<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The primary outcome was the proportion of patients with COVID-19 progression through day 29 (all-cause hospitalization lasting >24 hours for acute illness management or death); 5 secondary outcomes were tested in hierarchal order, including a composite of all-cause emergency department (ED) visit, hospitalization of any duration for acute illness management, or death through day 29 and progression to severe or critical respiratory COVID-19 requiring supplemental oxygen or mechanical ventilation.<\/p>\n\n\n\n

Results<\/strong>  Enrollment was stopped early for efficacy at the prespecified interim analysis. Among 1057 patients randomized (median age, 53 years [IQR, 42-62], 20% were \u226565 years of age, and 65% Latinx), the median duration of follow-up was 103 days for sotrovimab and 102 days for placebo. All-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6\/528 [1%]) vs placebo (30\/529 [6%]) (adjusted relative risk [RR], 0.21 [95% CI, 0.09 to 0.50]; absolute difference, \u20134.53% [95% CI, \u20136.70% to \u20132.37%]; P<\/em>\u2009<\u2009.001). Four of the 5 secondary outcomes were statistically significant in favor of sotrovimab, including reduced ED visit, hospitalization, or death (13\/528 [2%] for sotrovimab vs 39\/529 [7%] for placebo; adjusted RR, 0.34 [95% CI, 0.19 to 0.63]; absolute difference, \u20134.91% [95% CI, \u20137.50% to \u20132.32%]; P<\/em>\u2009<\u2009.001) and progression to severe or critical respiratory COVID-19 (7\/528 [1%] for sotrovimab vs 28\/529 [5%] for placebo; adjusted RR, 0.26 [95% CI, 0.12 to 0.59]; absolute difference, \u20133.97% [95% CI, \u20136.11% to \u20131.82%]; P<\/em>\u2009=\u2009.002). Adverse events were infrequent and similar between treatment groups (22% for sotrovimab vs 23% for placebo); the most common events were diarrhea with sotrovimab (n\u2009=\u20098; 2%) and COVID-19 pneumonia with placebo (n\u2009=\u200922; 4%).<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>\u00a0\u00a0Among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, significantly reduced the risk of a composite end point of all-cause hospitalization or death through day 29. The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT04545060<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation March 14, 2022 Ef […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21481"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21481"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21481\/revisions"}],"predecessor-version":[{"id":21986,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21481\/revisions\/21986"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}