{"id":19717,"date":"2020-12-29T04:53:00","date_gmt":"2020-12-28T20:53:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=19717"},"modified":"2021-01-07T06:15:03","modified_gmt":"2021-01-06T22:15:03","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87-%e4%b8%ad%e5%92%8c%e6%8a%97%e4%bd%93%e6%96%b0%e5%86%a0%e8%82%ba%e7%82%8e%e9%97%a8%e8%af%8a%e6%82%a3%e8%80%85","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=19717","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]: \u4e2d\u548c\u6297\u4f53\u9e21\u5c3e\u9152\u7597\u6cd5\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u95e8\u8bca\u60a3\u8005"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19<\/h1>\n\n\n\n

David M. Weinreich, Sumathi Sivapalasingam, Thomas Norton, et al<\/h3>\n\n\n\n

N Engl J Med December 17, 2020
DOI: 10.1056\/NEJMoa2035002<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h3>\n\n\n\n

Recent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads.<\/p>\n\n\n\n

METHODS<\/h3>\n\n\n\n

In this ongoing, double-blind, phase 1\u20133 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.4 g of REGN-COV2, or 8.0 g of REGN-COV2 and were prospectively characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody\u2013positive or serum antibody\u2013negative). Key end points included the time-weighted average change from baseline in viral load from day 1 through day 7 and the percentage of patients with at least one Covid-19\u2013related medically attended visit through day 29. Safety was assessed in all patients.<\/p>\n\n\n\n

RESULTS<\/h3>\n\n\n\n

Data from 275 patients are reported. The least-squares mean difference (combined REGN-COV2 dose groups vs. placebo group) in the time-weighted average change in viral load from day 1 through day 7 was \u22120.56 log10<\/sub> copies per milliliter (95% confidence interval [CI], \u22121.02 to \u22120.11) among patients who were serum antibody\u2013negative at baseline and \u22120.41 log10<\/sub> copies per milliliter (95% CI, \u22120.71 to \u22120.10) in the overall trial population. In the overall trial population, 6% of the patients in the placebo group and 3% of the patients in the combined REGN-COV2 dose groups reported at least one medically attended visit; among patients who were serum antibody\u2013negative at baseline, the corresponding percentages were 15% and 6% (difference, \u22129 percentage points; 95% CI, \u221229 to 11). The percentages of patients with hypersensitivity reactions, infusion-related reactions, and other adverse events were similar in the combined REGN-COV2 dose groups and the placebo group.<\/p>\n\n\n\n

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CONCLUSIONS<\/h3>\n\n\n\n

In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE REGN-COV2, a Neutralizing Antibody Coc […]<\/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\/19717"}],"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=19717"}],"version-history":[{"count":7,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/19717\/revisions"}],"predecessor-version":[{"id":19724,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/19717\/revisions\/19724"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=19717"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19717"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}