Background: COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. Materials and Methods: In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL. Results: There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22–94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported. Conclusions: This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).
There are many factors for in vitro fertilization (IVF) failure, and hereditary thrombophilia has been mentioned as one of them in the last few years. Thrombophilia is a condition of predisposition to thromboembolism. The aim of the study was to evaluate the sociodemographic characteristics and to examine the representation of thrombophilic mutations in women with IVF failure. Material and methods: In a retrospective-prospective case-control study we evaluated 52 women, divided in two groups. Twenty-twowomen with at least three IVF failures were included in the examined group (EG). Thirty women, age matched, who gave birth to at least one healthy child without obstetric complications were included in the control group. Presence of gene mutations for factor II Prothrombin (G20210A), factor V Leiden (FVL) and methylentetrahydrofolate reductase (MTHFR C677T) was examined in both groups. Sociodemographic data, data from personal, family and obstetric anamnesis was collected with standard questionnaire. Results: Representation of nationality in both groups roughly corresponds to the national structure in Republic of Macedonia. In both groups the most prevalent age was from 30 to 34 years (40% in the CG and 50% in the EG). According to the degree of education, homogeneity between the two groups was registered. In most of the EG, MTHFR heterozygous was 63.6% vs. 56.7% in the CG, followed by the FV Leiden heterozygous with 13.6% vs. 3.3% in the CG, MTHFR homozygous with 9.1% vs. 6.7% in CG, factor II Prothrombin (G20210A) heterozygous with 4.5% vs. 6.7 in CG. 72.7% of women in the EG and 60% in the CG had one thrombophilic mutation, and 9.1% of women in EG and 6.7% in CG had two thrombophilic mutations. 18.2% of women in EG and 33.3% in CG did not have any mutations. Conclusion: The sociodemographic profile of women with IVF failure is a woman aged between 30 and 34 years with a university degree, with at least one thrombophilic mutation. Thrombophilic mutation has not been registered in only a small percentage of women with failed IVF.
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