Efficacy and safety of regdanvimab in patients with mild/moderate COVID-19 and high risk of progression of the disease: a retrospective study in a short-term stay unit

Ulyana A. Markina; Маркина Ульяна Алексеевна; Daria S. Fomina; Фомина Дарья Сергеевна; Marina S. Lebedkina; Лебедкина Марина Сергеевна; Tatiana S. Kruglova; Круглова Татьяна Сергеевна; Anton A. Chernov; Чернов Антон Александрович; Alena I. Zagrebneva; Загребнева Алена Игоревна; Zinaida Yu. Mutovina; Мутовина Зинаида Юрьевна; Alexander V. Karaulov; Караулов Александр Викторович; Ekaterina I. Alexeeva; Алексеева Екатерина Иосифовна; Mariana A. Lysenko; Лысенко Марьяна Анатольевна

doi:10.26442/00403660.2022.05.201690

Efficacy and safety of regdanvimab in patients with mild/moderate COVID-19 and high risk of progression of the disease: a retrospective study in a short-term stay unit

Authors: Markina U.A.¹, Fomina D.S.²^,3, Lebedkina M.S.¹^,2, Kruglova T.S.¹, Chernov A.A.¹^,4, Zagrebneva A.I.¹^,5, Mutovina Z.Y.¹^,6, Karaulov A.V.², Alexeeva E.I.²^,7, Lysenko M.A.¹^,5
Affiliations:
1. City Clinical Hospital №52
2. Sechenov First Moscow State Medical University (Sechenov University)
3. Moscow City Scientific and Practical Center of Allergology and Immunology of City Clinical Hospital №52
4. Russian Medical Academy of Continuous Professional Education
5. Pirogov Russian National Research Medical University
6. Central State Medical Academy of the President of the Russian Federation
7. National Medical Research Center for Children's Health
Issue: Vol 94, No 5 (2022)
Pages: 675-682
Section: Original articles
URL: https://journals.rcsi.science/0040-3660/article/view/108790
DOI: https://doi.org/10.26442/00403660.2022.05.201690
ID: 108790

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Abstract
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Abstract

Background. The use of virus-neutralizing monoclonal antibodies is an effective method of etiotropic therapy for SARS-CoV-2 in patients of high-risk groups of severe COVID-19. Regdanvimab is a single-component monoclonal antibodies immunoglobulin G1, whose mechanism of action is aimed at binding SARS-CoV-2 virus at the RBD site of the spike protein S1 domain. In the Russian Federation, regdanvimab is approved for emergency administration in COVID-19 for adult patients not requiring respiratory therapy who are at high risk of developing a severe course of the disease.

Aim. To evaluate the efficacy and safety of therapy with regdanvimab in patients with mild/moderate COVID-19 in a short-term hospital unit.

Materials and methods. Virus-neutralizing therapy with regdanvimab was performed at the short-term hospital unit of the Moscow City Clinic. An open retrospective observational single-center study included 92 adult patients with mild/moderate coronavirus infection. All patients had comorbid chronic diseases and belonged to the high-risk group for the development of a severe COVID-19. Inclusion criteria: age 18 to 75 years; presence of a verified diagnosis of COVID-19 of mild/moderate COVID-19, polymerase chain reaction (PCR) confirmed; one or more chronic diseases; first 7 days from the onset of the first symptoms of COVID-19 (including day 7). Exclusion criteria: need for oxygen support. Clinical efficacy was assessed according to the World Health Organization Сlinical Progression Scale and supplemented with laboratory markers at baseline and in dynamics, as well as with monitoring of virus elimination by PCR.

Statistics. Calculations were performed using the statistical computing environment R 4.1.3 (R Foundation for Statistical Computing, Austria). For quantitative indices the median (1; 3 quartiles) was indicated. For binomial signs we calculated 95% confidence intervals according to Wilson's method. Time interval analysis was performed according to the Kaplan–Meier method. The significance level was determined at p<0.05.

Results. A significant decrease in the severity of clinical manifestations according to the World Health Organization Clinical Progression Scale was noted by patients by day 4 after regdanvimab administration. All 92 patients in the cohort were discharged from the hospital l on average on day 5 after regdanvimab administration and on day 9 of the disease. On day 4 after drug administration 82% of patients was being PCR negative. No adverse events related to the administration of regdanvimab were reported during the study.

Conclusion. In real clinical practice, the efficacy and safety of regdanvimab in patients at high risk of severe COVID-19 was confirmed once again, with a positive clinical result observed in a mixed cohort by the causative agent omicron and delta strain.

Keywords

COVID-19, monoclonal antibodies, viral neutralizing antibodies, comorbidities, regdanvimab, omicron

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About the authors

Ulyana A. Markina

City Clinical Hospital №52

Email: itchermd@gmail.com
ORCID iD: 0000-0002-6646-4233

врач – аллерголог-иммунолог отд-ния аллергологии и иммунологии ГБУЗ ГКБ №52

Russian Federation, Moscow

Daria S. Fomina

Sechenov First Moscow State Medical University (Sechenov University); Moscow City Scientific and Practical Center of Allergology and Immunology of City Clinical Hospital №52

Email: itchermd@gmail.com
ORCID iD: 0000-0002-5083-6637

канд. мед. наук, доц., доц. каф. клинической иммунологии и аллергологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет), рук. МГНПЦАИ ГБУЗ ГКБ №52

Russian Federation, Moscow; Moscow

Marina S. Lebedkina

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

Author for correspondence.
Email: itchermd@gmail.com
ORCID iD: 0000-0002-9545-4720

врач – аллерголог-иммунолог отд-ния аллергологии и иммунологии ГБУЗ ГКБ №52, клин. ординатор каф. клинической иммунологии и аллергологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет)

Russian Federation, Moscow; Moscow

Tatiana S. Kruglova

City Clinical Hospital №52

Email: itchermd@gmail.com
ORCID iD: 0000-0002-4949-9178

врач – аллерголог-иммунолог, зав. отд-нием аллергологии и иммунологии ГБУЗ ГКБ №52

Russian Federation, Moscow

Anton A. Chernov

City Clinical Hospital №52; Russian Medical Academy of Continuous Professional Education

Email: itchermd@gmail.com
ORCID iD: 0000-0001-6209-387X

врач-терапевт отд. клинической фармакологии ГБУЗ ГКБ №52, мл. науч. сотр. Научно-исследовательского института молекулярной и персонализированной медицины ФГБОУ ДПО РМАНПО

Russian Federation, Moscow; Moscow

Alena I. Zagrebneva

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

Email: itchermd@gmail.com
ORCID iD: 0000-0002-3235-1425

канд. мед. наук, зав. консультативно- диагностическим отд-нием №2 ГБУЗ ГКБ №52, доц. каф. общей терапии фак-та дополнительного профессионального образования ФГАОУ ВО «РНИМУ им. Н.И. Пирогова»

Russian Federation, Moscow; Moscow

Zinaida Yu. Mutovina

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

Email: itchermd@gmail.com
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

Alexander V. Karaulov

Sechenov First Moscow State Medical University (Sechenov University)

Email: itchermd@gmail.com
ORCID iD: 0000-0002-1930-5424

акад. РАН, д-р мед. наук, проф., зав. лаб. иммунопатологии Института молекулярной медицины, зав. каф. клинической иммунологии и аллергологии Института клинической медицины им. Н.В. Склифосовского ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет)

Russian Federation, 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

Mariana A. Lysenko

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

Email: itchermd@gmail.com
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

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