Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection

Rustem F. Khamitov; Хамитов Рустэм Фидагиевич; Vladimir V. Nikiforov; Никифоров Владимир Владимирович; Andrey A. Zaytsev; Зайцев Андрей Алексеевич; Irina N. Tragira; Трагира Ирина Николаевна

doi:10.26442/00403660.2022.01.201345

Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection

Authors: Khamitov R.F.¹, Nikiforov V.V.²^,3, Zaytsev A.A.⁴^,5, Tragira I.N.⁶
Affiliations:
1. Kazan State Medical University
2. Pirogov Russian National Research Medical University
3. Federal Scientific and Clinical Center for Specialized Types of Medical Care and Medical Technologies
4. Burdenko Main Military Clinical Hospital
5. Moscow State University of Food Production
6. National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Issue: Vol 94, No 1 (2022)
Pages: 83-93
Section: Original articles
URL: https://journals.rcsi.science/0040-3660/article/view/104767
DOI: https://doi.org/10.26442/00403660.2022.01.201345
ID: 104767

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Abstract

Aim. To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon γ, CD4 receptor, β₁ domain of the major histocompatibility complex class II and β₂ microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults.

Materials and methods. 240 patients 18–70 years old with ARVI were included in a phase III (2019–2020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction – PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed.

Results. The average time to resolution of ARVI (PCR-confirmed) was 4.1±1.9 [4.0±1.9] and 5.0±2.5 [5.0±2.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, р=0.0155 and [р=0.0114], respectively). The duration of ARVI decreased by 0.89±2.23 [0.93±2.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (р=0.0014 [р=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown.

Conclusion. Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza.

Keywords

ARVI, influenza, treatment, Raphamin, decreasing duration of illness

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About the authors

Rustem F. Khamitov

Kazan State Medical University

Author for correspondence.
Email: rhamitov@mail.ru
ORCID iD: 0000-0001-8821-0421

д-р мед. наук, проф., зав. каф. внутренних болезней ФГБОУ ВО «Казанский ГМУ»; гл. специалист эксперт-пульмонолог Управления здравоохранения по г. Казани

Russian Federation, Kazan

Vladimir V. Nikiforov

Pirogov Russian National Research Medical University; Federal Scientific and Clinical Center for Specialized Types of Medical Care and Medical Technologies

Email: rhamitov@mail.ru
ORCID iD: 0000-0002-2205-9674

д-р мед. наук, проф., зав. каф. инфекционных болезней и эпидемиологии лечебного фак-та ФГАОУ ВО «РНИМУ им. Н.И. Пирогова». зав. каф. инфекционных болезней и эпидемиологии Академии постдипломного образования ФГБУ ФНКЦ ФМБА России

Russian Federation, Moscow; Moscow

Andrey A. Zaytsev

Burdenko Main Military Clinical Hospital; Moscow State University of Food Production

Email: rhamitov@mail.ru
ORCID iD: 0000-0002-0934-7313

д-р мед. наук, проф., зав. каф. пульмонологии (с курсом аллергологии) Медицинского института непрерывного образования ФГБОУ ВО МГУПП, гл. пульмонолог ФГБУ «ГВКГ им. акад. Н.Н. Бурденко», гл. пульмонолог Минобороны России

Russian Federation, Moscow; Moscow

Irina N. Tragira

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Email: rhamitov@mail.ru
ORCID iD: 0000-0001-6370-779X

рук. Центра общей инфектологии

Russian Federation, Moscow

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