{"id":22916,"date":"2022-11-28T05:18:00","date_gmt":"2022-11-27T21:18:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=22916"},"modified":"2022-11-28T05:57:13","modified_gmt":"2022-11-27T21:57:13","slug":"lancet-infect-dis%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%8d%95%e5%89%82cairivimab%e5%92%8cimdevimab%e9%a2%84%e9%98%b2%e6%96%b0%e5%86%a0%e8%82%ba%e7%82%8e%e7%9a%84%e6%95%88%e6%9e%9c%e5%92%8c","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=22916","title":{"rendered":"[Lancet Infect Dis\u53d1\u8868\u8bba\u6587]\uff1a\u5355\u5242Cairivimab\u548cImdevimab\u9884\u9632\u65b0\u51a0\u80ba\u708e\u7684\u6548\u679c\u548c\u5b89\u5168\u6027"},"content":{"rendered":"\n

Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial<\/h1>\n\n\n\n

Gary A Herman, Meagan P O'Brien, Eduardo Forleo-Neto, et al<\/h3>\n\n\n\n

Lancet Infect Dis 2022; 22: 1444-1454<\/h3>\n\n\n\n

<\/p>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

There is an unmet need for COVID-19 prevention in patient populations who have not mounted or are not expected to mount an adequate immune response to complete COVID-19 vaccination. We previously reported that a single subcutaneous 1200 mg dose of the monoclonal antibody combination casirivimab and imdevimab (CAS\u2009+\u2009IMD) prevented symptomatic SARS-CoV-2 infections by 81\u00b74% in generally healthy household contacts of SARS-CoV-2-infected individuals over a 1-month efficacy assessment period. Here we present additional results, including the 7-month follow-up period (months 2\u20138), providing additional insights about the potential for efficacy in pre-exposure prophylaxis settings.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

This was a randomised, double-blind, placebo-controlled trial done in the USA, Romania, and Moldova in 2020\u20132021, before the emergence of omicron (B.1.1.529) and omicron-lineage variants. Uninfected and unvaccinated household contacts of infected individuals, judged by the investigator to be in good health, were randomly assigned (1:1) to receive 1200 mg CAS\u2009+\u2009IMD or placebo by subcutaneous injection according to a central randomisation scheme provided by an interactive web response system; randomisation was stratified per site by the test results of a local diagnostic assay for SARS-CoV-2 and age group at baseline. COVID-19 vaccines were prohibited before randomisation, but participants were allowed to receive COVID-19 vaccination during the follow-up period. Participants who developed COVID-19 symptoms during the follow-up period underwent RT-PCR testing. Prespecified endpoints included the proportion of previously uninfected and baseline-seronegative participants (seronegative-modified full analysis set) who had RT-PCR-confirmed COVID-19 in the follow-up period (post-hoc for the timepoints of months 2\u20135 and 6\u20138 only) and underwent seroconversion (ie, became seropositive, considered a proxy for any SARS-CoV-2 infections [symptomatic and asymptomatic]; prespecified up to day 57, post-hoc for all timepoints thereafter). We also assessed the incidence of treatment-emergent adverse events. This study is registered with ClinicalTrials.gov<\/a>, NCT04452318<\/a>.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

From July 13, 2020, to Oct 4, 2021, 2317 participants who were RT-PCR-negative for SARS-CoV-2 were randomly assigned, of whom 1683 (841 assigned to CAS\u2009+\u2009IMD and 842 assigned to placebo) were seronegative at baseline. During the entirety of the 8-month study, CAS\u2009+\u2009IMD reduced the risk of COVID-19 by 81\u00b72% (nominal p<0\u00b70001) versus placebo (prespecified analysis). During the 7-month follow-up period, protection was greatest during months 2\u20135, with a 100% relative risk reduction in COVID-19 (nominal p<0\u00b70001; post-hoc analysis). Efficacy waned during months 6\u20138 (post-hoc analysis). Seroconversion occurred in 38 (4\u00b75%) of 841 participants in the CAS\u2009+\u2009IMD group and in 181 (21\u00b75%) of 842 in the placebo group during the 8-month study (79\u00b70% relative risk reduction vs<\/em> placebo; nominal p<0\u00b70001). Six participants in the placebo group were hospitalised due to COVID-19 versus none who received CAS\u2009+\u2009IMD. Serious treatment-emergent adverse events (including COVID-19) were reported in 24 (1\u00b77%) of 1439 participants receiving CAS\u2009+\u2009IMD and in 23 (1\u00b76%) of 1428 receiving placebo. Five deaths were reported, none of which were due to COVID-19 or related to the study drugs.<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n

Interpretation<\/h3>\n\n\n\n

CAS\u2009+\u2009IMD is not authorised in any US region as of Jan 24, 2022, because data show that CAS\u2009+\u2009IMD is not active against omicron-lineage variants. In this study, done before the emergence of omicron-lineage variants, a single subcutaneous 1200 mg dose of CAS\u2009+\u2009IMD protected against COVID-19 for up to 5 months of community exposure to susceptible strains of SARS-CoV-2 in the pre-exposure prophylaxis setting, in addition to the post-exposure prophylaxis setting that was previously shown.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

Regeneron Pharmaceuticals, F Hoffmann-La Roche, US National Institute of Allergy and Infectious Diseases, US National Institutes of Health.<\/p>\n\n\n\n

ARTICLES| VOLUME 22, ISSUE 10<\/a>, P1444-1454, OCTOBER 01, 2022<\/p>\n\n\n\n

<\/h1>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Efficacy and safety of a single dose of casirivimab and […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22916"}],"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=22916"}],"version-history":[{"count":3,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22916\/revisions"}],"predecessor-version":[{"id":23159,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22916\/revisions\/23159"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22916"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22916"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22916"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}