Phase I Pharmacokinetics Study of Drug «COVID-globulin» (Specific Human Immunoglobulin Against COVID-19)

Introductio n. Coronavirus infection is an acute viral disease with a predominant lesion of the upper respiratory tract caused by RNA-containing virus Coronaviridae family. However, it known that neutralizing antibodies play important role in antiviral therapy because they effectively inhibit reproduction viruses and reduce severity disease. Polyclonal contained convalescent plasma are usually used as emergency for emerging infectious diseases. In this aspect, use human immunoglobulin G preparation containing specific to SARS-CoV-2 ("COVID-globulin") appears be safer more effective. Aim. The aim pharmacokinetics study drug "COVID-globulin" (specific against COVID-19, solution infusions, not less than 160 anti-COVID units/mL (ACU/mL), JSC "NPO Microgen", owner registration certificate "Natsibio", Russia), addition standard treatment patients middle-grade COVID-19. Materials methods. clinical analytical stages "COVID-globulin", well analysis safety parameters were carried part safety, tolerability ("COVID-globulin"), " Natsibio", Russia. Quantitative determination antibody concentrations was out enzyme-linked immunosorbent assay using spectrophotometric detection visible range spectrum on automatic plate analyzer Lazurite (Dynex Technologies Inc., USA). calculation pharmacokinetic Microsoft Excel package extension Boomer (Department Pharmacokinetics Drug Metabolism, Allergan, Irvine, CA 92606, Results discussion. No serious adverse events reported study, only event resulted volunteer withdrawing from related drug. calculated two batches drugs. (the content – 330 ACU/ml) assessed sample 8 volunteers. maximum concentration IgG 25.46 ± 8.71 ACU/ml (Mean SD, where Mean arithmetic mean, SD deviation). median value time 0.25 hours. Specific eliminated blood half-life 266.89 59.92 250 15 20.93 3.82 ACU/ml. 295.56 50.68 Conclusion. According results profile favorable. Based obtained during stage main calculated, average profiles test plotted after single injection. basis subsequent phases trials "COVID-globulin".