{"id":20034,"date":"2021-03-17T05:13:00","date_gmt":"2021-03-16T21:13:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=20034"},"modified":"2021-03-19T06:47:02","modified_gmt":"2021-03-18T22:47:02","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87-%e4%b8%ad%e5%92%8c%e5%8d%95%e5%85%8b%e9%9a%86%e6%8a%97%e4%bd%93%e6%b2%bb%e7%96%97%e6%96%b0%e5%86%a0%e8%82%ba%e7%82%8e%e4%bd%8f%e9%99%a2%e6%82%a3%e8%80%85","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=20034","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]: \u4e2d\u548c\u5355\u514b\u9686\u6297\u4f53\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u4f4f\u9662\u60a3\u8005"},"content":{"rendered":"\n

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

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19<\/h1>\n\n\n\n

ACTIV-3\/TICO LY-CoV555 Study Group<\/h3>\n\n\n\n

N Engl J Med 2021; 384:905-914
DOI: 10.1056\/NEJMoa2033130<\/h3>\n\n\n\n

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

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

LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.<\/p>\n\n\n\n

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

In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.<\/p>\n\n\n\n

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

On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P=0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P=0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).<\/p>\n\n\n\n

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

Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE A Neutralizing Monoclonal Antibody for […]<\/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\/20034"}],"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=20034"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20034\/revisions"}],"predecessor-version":[{"id":20035,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20034\/revisions\/20035"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}