Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients—An Open-Label Phase II Clinical Trial

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)

The bear in Eurasian plant names: Motivations and models

Ethnolinguistic studies are important for understanding an ethnic group's ideas on the world, expressed in its language. Comparing corresponding aspects of such knowledge might help clarify problems of origin for certain concepts and words, e.g. whether they form common heritage, have an independent origin, are borrowings, or calques. The current study was conducted on the material in Slavonic, Baltic, Germanic, Romance, Finno-Ugrian, Turkic and Albanian languages. The bear was chosen as being a large, dangerous animal, important in traditional culture, whose name is widely reflected in folk plant names. The phytonyms for comparison were mostly obtained from dictionaries and other publications, and supplemented with data from databases, the co-authors' field data, and archival sources (dialect and folklore materials). More than 1200 phytonym use records (combinations of a local name and a meaning) for 364 plant and fungal taxa were recorded to help find out the reasoning behind bear-nomination in various languages, as well as differences and similarities between the patterns among them. Among the most common taxa with bear-related phytonyms were Arctostaphylos uva-ursi (L.) Spreng., Heracleum sphondylium L., Acanthus mollis L., and Allium ursinum L., with Latin loan translation contributing a high proportion of the phytonyms. Some plants have many and various bear-related phytonyms, while others have only one or two bear names. Features like form and/or surface generated the richest pool of names, while such features as colour seemed to provoke rather few associations with bears. The unevenness of bear phytonyms in the chosen languages was not related to the size of the language nor the present occurence of the Brown Bear in the region. However, this may, at least to certain extent, be related to the amount of the historical ethnolinguistic research done on the selected languages

Nivolumab-induced lichenoid granulomatous stomatitiin a patient with advanced melanoma: A case report

Lichenoid granulomatous reactions (LGR) are granulomatous inflammations of the skin and oral mucosa, also sharing features of lichenoid lesions. Thus, the present study refers to lichenoid granulomatous dermatitis (LGD) and lichenoid granulomatous stomatitis (LGS). LGR is a condition that can be triggered by drugs, diseases or environmental causes. In the present case study, anti-PD1 (nivolumab) medication had a detrimental effect on the oral mucosa, which clinicaly and histologicaly proved to be LGS. Checkpoint inhibitors consitute a cornerstone in the current treatment of several types of cancer, of which cutaneous melanoma is the best example. Oral lichenoid responses following anti-PD-1 therapy have been recorded in few case reports and small case series. To the best of our knowledhe, this is the first case of LGS being reported as a side effect of immune checkpoint inhibitor treatment. © 2022, Spandidos Publications. All rights reserved

Prognostic value of brain natriuretic peptide in COVID-19 with or without acute heart failure

Background Although Brain Natriuretic Peptide (BNP) provides strong prognostic information of an unfavorable outcome in patients with acute heart failure (AHF), there is little information of its relevance as a biomarker for outcomes in COVID-19 and its complications Purpose To evaluate the association of increased BNP levels with complications and in-hospital mortality in a cohort of hospitalized COVID-19 patients. Methods The study included COVID-19 patients with data on BNP levels included in the ISACS COVID-19 registry. The population was categorized according to the presence of peak BNP levels ≥100 pg/mL during hospitalization. Primary outcomes included in-hospital mortality, AHF or acute respiratory failure (ARF, defined as PiO2/FiO2&lt;300 mmHg or need for mechanical ventilation). Calculations were conducted using age and sex-adjusted multivariable logistic regression analyses. Results were also stratified according to presence or absence of cardiovascular disease (CVD) history. Differences between subgroups were verified for statistical significance using test for interaction. Results Of the 1152 patients included in the study, 615 (53.4%) had elevated BNP levels. These subjects were older (69.9±13.8 vs 59.1±16.8, p-value&lt;0.001), had higher rates of cardiovascular risk factors (82.9% vs 57.7%, p-value&lt;0.001) and presented more frequently with a prior history of CVD (either ischemic heart disease, cerebrovascular disease, venous thromboembolism, atrial fibrillation or a history of revascularization) (50.1% vs 27.5%, p-value&lt;0.001). No sex differences were observed. When considering outcomes, BNP levels ≥100 pg/mL were associated with increased rates of in-hospital mortality (32.9% vs 4.9%, p-value&lt;0.001), even after adjustment for demographic characteristics (OR: 7.35; 95% CI: 4.75–11.40; p-value&lt;0.001). High BNP levels were also strongly associated with an increased risk of AHF (OR 19.9; 95% CI 8.6–45.9; p-value&lt;0.001), a correlation that persisted both in patients with and without a prior CVD history (p for interaction=0.29). Of note, patients with elevated BNP also had a higher likelihood of developing ARF (OR 2.7; 95% CI 2.1–3.6; p-value&lt;0.001), even in absence of AHF (OR 3.00; 95% CI 2.20–4.1; p-value&lt;0.001). Conclusions In COVID-19, blood BNP level not only appears to be predictor of in-hospital mortality and AHF but was also independently associated with an increased risk of ARF. This finding supports the routine use of BNP in all patients admitted to hospital for COVID-19, regardless of a prior history of CVD

Relationship Between Azithromycin and Cardiovascular Outcomes in Unvaccinated Patients With COVID-19 and Preexisting Cardiovascular Disease

Background Empiric antimicrobial therapy with azithromycin is highly used in patients admitted to the hospital with COVID-19, despite prior research suggesting that azithromycin may be associated with increased risk of cardiovascular events. Methods and Results This study was conducted using data from the ISACS-COVID-19 (International Survey of Acute Coronavirus Syndromes-COVID-19) registry. Patients with a confirmed diagnosis of SARS-CoV-2 infection were eligible for inclusion. The study included 793 patients exposed to azithromycin within 24 hours from hospital admission and 2141 patients who received only standard care. The primary exposure was cardiovascular disease (CVD). Main outcome measures were 30-day mortality and acute heart failure (AHF). Among 2934 patients, 1066 (36.4%) had preexisting CVD. A total of 617 (21.0%) died, and 253 (8.6%) had AHF. Azithromycin therapy was consistently associated with an increased risk of AHF in patients with preexisting CVD (risk ratio [RR], 1.48 [95% CI, 1.06-2.06]). Receiving azithromycin versus standard care was not significantly associated with death (RR, 0.94 [95% CI, 0.69-1.28]). By contrast, we found significantly reduced odds of death (RR, 0.57 [95% CI, 0.42-0.79]) and no significant increase in AHF (RR, 1.23 [95% CI, 0.75-2.04]) in patients without prior CVD. The relative risks of death from the 2 subgroups were significantly different from each other (Pinteraction=0.01). Statistically significant association was observed between AHF and death (odds ratio, 2.28 [95% CI, 1.34-3.90]). Conclusions These findings suggest that azithromycin use in patients with COVID-19 and prior history of CVD is significantly associated with an increased risk of AHF and all-cause 30-day mortality. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT05188612