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

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.