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THE RESULTS OF THE CLINICAL STUDY: AN OPEN-LABEL MULTICENTER RANDOMIZED TRIAL TO EVALUATE THE EFFICACY OF BIOVEN, MANUFACTURED BY BIOPHARMA PLASMA, LLC, IN COMPLEX THERAPY OF PATIENTS WITH PNEUMONIA INDUCED BY COVID-19/SARS-COV-2

Authors: Cлавута, Г. Б.;

THE RESULTS OF THE CLINICAL STUDY: AN OPEN-LABEL MULTICENTER RANDOMIZED TRIAL TO EVALUATE THE EFFICACY OF BIOVEN, MANUFACTURED BY BIOPHARMA PLASMA, LLC, IN COMPLEX THERAPY OF PATIENTS WITH PNEUMONIA INDUCED BY COVID-19/SARS-COV-2

Abstract

У статті представлені результати відкритого багатоцентрового рандомізованого клінічного дослідження з оцінки ефективності препарату Біовен, виробництва ТОВ «Біофарма Плазма». Дане дослідження було проведене в Україні у 9 клініках. Внутрішньовенний імуноглобулін, Біовен, застосовувався в комплексній терапії пацієнтів з пневмонією, що викликана коронавірусною інфекцією COVID-19 / SARS-CoV-2, у дозі 0,8-1,0 г/кг протягом 2 діб (курсова доза – 1.6-2.0 г/кг маси тіла). Препарат Біовен підтвердив свою клінічну ефективність у даної категорії хворих, що зафіксовано в більш швидкій нормалізації клінічного стану, зростанні абсолютної кількості лімфоцитів як одного з найбільш прогностично значущих критеріїв тяжкості COVID-19, та достовірному зменшенні летальності в порівнянні з контрольною групою. Цей позитивний результат можна пояснити імуномоделюючою дією високих доз внутрішньовенного імуноглобуліну, що впливає на цитокіновий шторм, який вважається одним з основних патогенетичних механізмів тяжкого перебігу COVID-19.

The article presents an open multicenter randomized clinical trial to evaluate the effectiveness of the drug Bioven, manufactured by «Biopharma Plasma», LLC. This study was conducted in Ukraine on 9 clinical sites. IVIG (trade name – Bioven) used in the complex therapy of patients with pneumonia caused by coronavirus infection COVID-19 / SARS-CoV-2, at a dose of 0.8-1.0 g / kg body weight per day, for two days (course dose - 1.6-2.0 g / kg body weight). Bioven confirmed clinical efficacy for patients with severe COVID-19 pneumonia. Was achieved the faster clinical improvement, normalization of absolute lymphocytes count - one of the most prognostic criteria for the severity of COVID-19, and mortality caused by COVID-19 was significantly reduced. This positive result can be explained by the immunomodulatory effect of high doses of intravenous immunoglobulins (IVIG), which affects the cytokine storm, the primary pathogenetic mechanism of severe COVID-19.

Keywords

Covid-19; тяжка пневмонія; внутрішньовенний імуноглобулін; Біовен, 616.24-002, Covid-19; severe pneumonia; intravenous immunoglobulin; Bioven

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
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