Objective and design The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19. Subjects The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia. Treatment 206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy. Methods The primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders. Results 63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 (P = .0017). The frequency of adverse drug reactions was comparable between the groups. Conclusion In patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate. Trail registration The trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).

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Introduction. A number of researchers point at a direct connection between mutations of genes affecting the haemostasis system and risks of venous thromboembolism and / or infertility. Quite often,  a thrombophilia diagnosis is a result of overdiagnosis, which may lead to ungrounded and even  dangerous medical prescriptions. In this context, the key goal of this work was to analyse the  homeostasis system in women with recurrent pregnancy loss and establishes the causes of this phenomenon.Materials and methods. Over the course of this work, we analysed 79 women in various stages of pregnancy who were receiving treatment in the Pregnancy Pathology Department of the BSMU Clinic. We analysed their medical histories, Body Mass Indexes (BMI), polymorphisms of haemostasis system genes and thrombosis risk factors.Results and discussion. BMI analysis found normal body mass in 39 patients (49.4 %) and excessive body mass in 40 patients (50.6 %). F2 and F5 gene polymorphisms were almost entirely absent. ITGA2  and ITGB3 gene mutations were found in the patients analysed in 48.1 % and 17.7 % of the cases,  respectively. PAI-1 gene mutations were found in 84.8 % of cases. MTR and MTRR gene polymorphisms  were detected in 35.4 % and 81.0 % of the patients, respectively. MTHFR mutations were found in more than 40 % of the patients.Conclusion. Obesity and hereditary thrombophilia are primary factors in venous thromboembolism. Body weight loss and antithrombotic therapy reduce risk obstetric complications, improving prognosis and pregnancy outcomes.