{"id":39663,"date":"2021-01-22T07:19:11","date_gmt":"2021-01-22T07:19:11","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39663"},"modified":"2021-01-26T13:19:08","modified_gmt":"2021-01-26T13:19:08","slug":"study-using-monoclonal-antibody-bamlanivimab-in-advanced-covid-19-stopped-early-due-to-lack-of-effect","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39663","title":{"rendered":"Monoclonal antibody bamlanivimab is not effective in advanced COVID-19: lack of early signal stops study early"},"content":{"rendered":"
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<\/span>Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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A phase 3 study using the COVID-19 monoclonal antibody bamlanivimab (formerly LY-CoV555) in advanced infection was stopped early due to lack of activity: other studies continue in earlier infection. <\/span><\/strong><\/p>\n<\/div>\n

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This was a randomised placebo-controlled study using a single infusion of bamlanivimab, with a primary endpoint of sustained recovery over 90 days. Results were published in the NEJM. [1]<\/span><\/p>\n<\/div>\n

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On 9 November 2020, this compound received emergency use authorisation from the FDA. [2]<\/span><\/p>\n<\/div>\n

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From 5 August to 13 October 2020, the study enrolled 326 participants in 31 sites (23 in the US, 7 in Denmark and 1 in Singapore). On 26 October however, the study was closed early after a recommendation from the Data and Safety Monitoring Board (DSMB). This was due to no impact on lung function at day 5 using a seven-category ordinal scale based on oxygen requirements. This is similar to the scale that showed faster recovery benefits with remdesivir.<\/span><\/p>\n<\/div>\n

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If the five-day results had shown a benefit, the study would have advanced to enrol over 1000 participants.<\/span><\/p>\n<\/div>\n

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At day five, 81 patients (50%) in the bamlanivimab group and 81 (54%) in the placebo group were in one of the two categories of the pulmonary scale.<\/span><\/p>\n<\/div>\n

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Across all categories, the odds ratio of bamlanivimab participants being in a higher category was 0.85 (95% CI: 0.56 to 1.29), p=0.45.<\/span><\/p>\n<\/div>\n

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There were no differences in the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5): 19% vs 14%, OR: 1.56 (95%CI: 0.78 to 3.10), p=0.020 or in the rate ratio for a sustained recovery: 1.06 (95% CI, 0.77 to 1.47).<\/span><\/p>\n<\/div>\n

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comment<\/span><\/h3>\n<\/div>\n
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This was the first of the US NIH-funded TICO (Therapeutics for Inpatients with Covid-19) studies to look at multiple monoclonal antibodies. The study will continue follow-up in participants who already received bamlanivimab.<\/span><\/strong><\/p>\n<\/div>\n

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Although these results are disappointing, the early analysis for lack of effect limited unnecessary risks for additional participants. <\/span><\/strong><\/p>\n<\/div>\n

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New antibodies already added in the next stage of the ACTIV-3 study include VIR-7831 from GSK and a dual combination of BRII-196 and BRII-198 from Brii Sciences. [3]<\/span><\/strong><\/p>\n<\/div>\n

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Other studies using bamlanivimab continue in earlier stage infection. [4]<\/span><\/strong><\/p>\n<\/div>\n

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References<\/p>\n<\/div>\n

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  1. A<\/span>CTIV-3\/TICO LY-CoV555 study group. A neutralizing monoclonal antibody for hospitalized patients with Covid-19. NEJM. DOI: 10.1056\/NEJMoa2033130 |. (22 December 2020).
    \nhttps:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2033130<\/a><\/li>\n
  2. FDA. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19. (9 November 2020).
    \n    https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19<\/a><\/li>\n
  3. ClinicalTrials.gov. <\/span>ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO).
    \n    https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04501978<\/a><\/li>\n
  4. ClinicalTrials.gov. ACTIV-2: A study for outpatients with COVID-19.
    \n    https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04518410<\/a><\/li>\n<\/ol>\n

    This report was first posted on 10 January 2021.<\/em><\/p>\n<\/div>\n

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

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    \u00a0<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base A phase 3 study using the COVID-19 monoclonal antibody bamlanivimab (formerly LY-CoV555) in advanced infection was stopped early due to lack of activity: other studies continue in earlier infection. This was a randomised placebo-controlled study using …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-39663","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39663","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=39663"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39663\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39663"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39663"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}