Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection

Aim: to assess the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for outpatient treatment of moderate-to-severe COVID-19 infection. Patients and Methods: this adaptive, randomized, open-label controlled study on the efficacy and safety of enisamium iodide enrolled 194 patients. The study group included 97 patients, and the comparison group included 97 patients. Comparison group patients received standard therapy. Study group patients received orally 500 mg of enisamium iodide three times daily for seven days. In addition, pathogenic and symptomatic treatment was prescribed. The first component of the primary endpoint was composite efficiency parameter. The second component of the primary endpoint was the proportion of patients with respiratory failure. Registration of deaths, adverse events and serious adverse events was carried out by standard methods. Results: cohort enrollment into part 1 of the study and treatment of all patients were completed. The mean time of the relief of major COVID-19 symptoms (primary combination endpoint) and differences between the study and comparison groups (8 days and 9 days, respectively, p=0.028) were revealed. The rate of respiratory failure in the study group and comparison group was: 4 (4,12%) versus 8 (8,25%) cases respectively. In addition, the effect of this drug on mortality in the groups was compared (one death in the study group and five deaths in the comparison group). The statistical reliability of these differences will be determined during part 2 of this study that started in September 2021. Conclusions: the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for the COVID-19 were evaluated. A significant reduction in the time to clinical recovery (by one day) was reported in patients who received enisamium iodide. In addition, the rate of severe respiratory failure and associated mortality also tends to reduce after therapy that includes enisamium iodide. KEYWORDS: enisamium iodide, antivirals, etiopathogenic treatment, SARS-CoV-2, COVID-19, viral lung damage, pneumonia, randomized controlled study, adaptive study, open-label study. FOR CITATION: N.Yu. Pshenichnaya, Zhdanov K.V. Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection. Russian Medical Inquiry. 2021;5(11):705–711 (in Russ.). DOI: 10.32364/2587-6821-2021-5-11-705-711.

Growth and Characterizes of PbI2 Films By Vacuum Evaporation Method

In this work, thin films of lead iodide (PbI2) were deposited on glass substrates with different thicknesses by vacuum thermal evaporation method. The structural, chemical, electrical and optical characteristics of the thin films were studied. XRD analysis showed that lead iodide film is polycrystalline having hexagonal structure. A particle size was estimated by Williamson - Hall technique (13) nm and strain (4.90*10-3) are founded from the intercept with y-axis and slope for PbI2. The UV-VIS measurements illustrated that the lead iodide has a direct optical band gap and Urbach energy to be 0.677 eV2. Raman peaks are detected at 70, 96, 99.5, 188 and 202 cm-1 which corresponding to characteristic of PbI2 at (E21, A11, 2E11 and A1g). The FTIR spectrum of PbI2 thin film showed six bands at 1650, 1900, 3100, 3400, 3600 and 3800 cm-1. Mechanism of dc transport was also analyzed in the temperature range 315–395 K. Also the variation of reflectivity in the range near infrared is conductive generally attributed to thin film nature, where this film contain light scattering and large surface area, which enhance the optical absorption and hence, a low reflectivity is obtained.

Гетероструктура для обращенного диода на основе электроосажденного в импульсном режиме наномассива оксида цинка и изготовленной методом SILAR пленки иодида меди

A heterostructure promising for designing a backward diode is formed from a zinc-oxide nanorod array and a nanostructured copper-iodide film. The effect of modes of successive ionic layer adsorption and reaction (SILAR) deposition and the subsequent iodization of CuI films on smooth glass, mica, and fluorine-doped tin oxide (FTO) substrates and on the surface of electrodeposited nanostructured zinc-oxide arrays on the film structure and electrical and optical properties is investigated. A connection between the observed variations in the structure and properties of this material and intrinsic and iodination-induced point defects is established. It is found that the cause and condition for creating a backward-diode heterostructure based on a zinc-oxide nanoarray formed by pulsed electrodeposition and a copper-iodide film grown by the SILAR method is the formation of a p ^+-CuI degenerate semiconductor by the excessive iodination of layers of this nanostructured material through its developed surface. The n -ZnO/ p ^+-CuI barrier heterostructure, which is fabricated for the first time, has the I – V characteristic of a backward diode, the curvature factor of which (γ = 12 V^–1) confirms its high Q factor.