Use of a combination of the virus-neutralizing monoclonal antibodies casirivimab and imdevimab for mild to moderate COVID-19 in patients at high risk of progression: Results of the non-interventional observational study

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Abstract

Aim. To evaluate the efficacy and safety of a combination of virus-neutralizing monoclonal antibodies – MAB (casirivimab and imdevimab) in patients with mild to moderate COVID-19 with risk factors in real word settings.

Materials and methods. A non-interventional non-comparative observational study with primary prospective data collection included 108 patients with mild to moderate COVID-19 (mean age 61 years), who had risk factors for developing severe disease. All patients (n=108) were treated with a combination of MAB casirivimab and imdevimab intravenous single infusion 1200 mg (600 mg of each component). The efficacy and safety of MAB were assessed at 7, 14, and 28 days after infusion.

Results. Efficacy. Indications for hospitalization by day 7 from the moment of MAB administration were in 0.9% (n=1), by day 14 – in 1.9% (n=2), by day 28 – in 0.9% of patients; to stay in the intensive care units by the 7th day – in 4.6% (n=5), by the 14th day – in 0.9% (n=1), by the 28th day – in 0.9% (n=1) patients. During 28 days of follow up, the need for mechanical ventilation and extracorporeal membrane oxygenation was registered in 2/108 (1.8%) patients. There were no deaths directly related to COVID-19 in the assessed cohort of patients. Safety. By the 28th day of the follow up, no adverse effects due to MAB therapy were registered.

Conclusion. An analysis of the results of a non-interventional observational study summarized in this article showed the high efficacy and safety of virus-neutralizing MAB combination (casirivimab and imdevimab) in patients with mild to moderate COVID-19 with of risk factors for severe COVID-19 in real word settings.

About the authors

Marina S. Lebedkina

City Clinical Hospital №52, Moscow

Email: roppelt_anna@mail.ru
ORCID iD: 0000-0002-9545-4720

врач – аллерголог-иммунолог Московского городского научно-практического центра аллергологии и иммунологии ГБУЗ «ГКБ №52»

Russian Federation, Moscow

Daria S. Fomina

City Clinical Hospital №52, Moscow; Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: daria_fomina@mail.ru
ORCID iD: 0000-0002-5083-6637
SPIN-code: 3023-4538

MD, Dr. Sci. (Med.), Associate Professor

Russian Federation, Moscow; Moscow

Zinaida Y. Mutovina

City Clinical Hospital №52, Moscow; Central State Medical Academy of the President of the Russian Federation

Email: zmutovina@mail.ru
ORCID iD: 0000-0001-5809-6015

канд. мед. наук, врач-ревматолог, зав. ревматологическим отд-нием ГБУЗ «ГКБ №52», доц. каф. общей терапии, кардиологии и функциональной диагностики ФГБУ ДПО ЦГМА УД Президента РФ

Russian Federation, Moscow; Moscow

Ulyana A. Mаrkina

City Clinical Hospital №52, Moscow

Email: roppelt_anna@mail.ru
ORCID iD: 0000-0002-6646-4233

врач – аллерголог-иммунолог Московского городского научно-практического центра аллергологии и иммунологии ГБУЗ «ГКБ №52»

Russian Federation, Moscow

Pavel O. Bogomolov

Vladimirsky Moscow Regional Research Clinical Institute; Yevdokimov Moscow State University of Medicine and Dentistry

Email: hepatology@monikiweb.ru
ORCID iD: 0000-0003-2346-1216

канд. мед. наук, рук. отд-ния гепатологии ГБУЗ МО «МОНИКИ им. М.Ф. Владимирского», доц. каф. пропедевтики внутренних болезней, гастроэнтерологии ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»

Russian Federation, Moscow; Moscow

Vladimir P. Chulanov

Sechenov First Moscow State Medical University (Sechenov University); National Medical Research Center of Tuberculosis and Infectious Diseases

Email: ChulanovVP@nmrc.ru
ORCID iD: 0000-0001-6303-9293
SPIN-code: 2336-4545

д-р мед. наук, проф., проф. каф. инфекционных болезней Института клинической медицины им. Н.В. Склифосовского ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет), зам. дир. по научной работе и инновационному развитию ФГБУ НМИЦ ФПИ

Russian Federation, Moscow; Moscow

Mariana A. Lysenko

City Clinical Hospital №52, Moscow; Pirogov Russian National Research Medical University

Email: alrheumo@mail.ru
ORCID iD: 0000-0001-6010-7975

д-р мед. наук, глав. врач ГБУЗ «ГКБ №52», проф. каф. общей терапии фак-та дополнительного профессионального образования ФГАОУ ВО «РНИМУ им. Н.И. Пирогова»

Russian Federation, Moscow; Moscow

Ekaterina I. Alexeeva

Sechenov First Moscow State Medical University (Sechenov University); National Medical Research Center for Children's Health

Email: itchermd@gmail.com
ORCID iD: 0000-0002-3874-4721

чл.-кор. РАН, д-р мед. наук, проф., дир. Клинического института детского здоровья им. Н.Ф. Филатова ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет), зав. ревматологическим отд-нием ФГАУ «НМИЦ здоровья детей»

Russian Federation, Moscow; Moscow

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Change of the effectiveness criteria for the casirivimab and imdevimab combination (incidence rate).

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