Assessment of Reactivity to the Administration of the mRNA Vaccine after Six Months of Observation.

BACKGROUND: The fast spread of the SARS-CoV-2 virus accelerated efforts to create an effective vaccine, and a novel mRNA vaccine was the first to appear effective. Scientific evidence regarding mRNA vaccination is limited; therefore, understanding how the immune system responds to an mRNA vaccine is critical. Our study was aimed at a long-term analysis of the presence and maintenance of the immune response using the chemiluminescent method by analyzing the level of IgG antibodies in vaccinated people who were and were not infected with the SARS-CoV-2 virus. MATERIALS AND METHODS: Healthcare workers with a history of COVID-19 or who were naïve to the infection were recruited for this study and administered two subsequent doses of the Comirnaty vaccine. IgG SRBD antibody levels were evaluated every month for six consecutive months using the chemiluminescent immunoassay (CLIA). RESULTS: A total of 149 individuals were recruited for this study, 68 had evidence of past COVID-19 infection, with 63 exhibiting elevated IgG SRBD antibody levels at initial evaluation. Statistically significant differences were observed between COVID-19 convalescents and non-convalescents at all study time points, with the convalescent group consequently representing higher antibody levels. CONCLUSIONS: COVID-19 convalescents showed a stronger immune response to the vaccine after the first dose. This group exhibited higher IgG levels in all examinations during the observation period. The natural waning of antibody levels can be observed within six months. A booster vaccination may be required. No serious side effects were observed.

The association of airborne particulate matter and benzo[a]pyrene with the clinical course of COVID-19 in patients hospitalized in Poland.

Air pollution can adversely affect the immune response and increase the severity of the viral disease. The present study aimed to explore the relationship between symptomatology, clinical course, and inflammation markers of adult patients with coronavirus disease 2019 (COVID-19) hospitalized in Poland (n = 4432) and air pollution levels, i.e., mean 24 h and max 24 h level of benzo(a)pyrene (B(a)P) and particulate matter <10 µm (PM10) and <2.5 µm (PM2.5) during a week before their hospitalization. Exposures to PM2.5 and B(a)P exceeding the limits were associated with higher odds of early respiratory symptoms of COVID-19 and hyperinflammatory state: interleukin-6 > 100 pg/mL, procalcitonin >0.25 ng/mL, and white blood cells count >11 × 103/mL. Except for the mean 24 h PM10 level, the exceedance of other air pollution parameters was associated with increased odds for oxygen saturation <90%. Exposure to elevated PM2.5 and B(a)P levels increased the odds of oxygen therapy and death. This study evidences that worse air quality is related to increased severity of COVID-19 and worse outcome in hospitalized patients. Mitigating air pollution shall be an integral part of measures undertaken to decrease the disease burden during a pandemic of viral respiratory illness.

Remdesivir Decreases Mortality in COVID-19 Patients with Active Malignancy.

Data on the use of remdesivir, the first antiviral agent against SARS-CoV-2, are limited in oncologic patients. We aimed to analyze contributing factors for mortality in patients with malignancies in the real-world CSOVID-19 study. In total, 222 patients with active oncological disorders were selected from a nationwide COVID-19 study of 4890 subjects. The main endpoint of the current study was the 28-day in-hospital mortality. Approximately half of the patients were male, and the majority had multimorbidity (69.8%), with a median age of 70 years. Baseline SpO2 < 85% was observed in 25%. Overall, 59 (26.6%) patients died before day 28 of hospitalization: 29% due to hematological, and 20% due to other forms of cancers. The only factor increasing the odds of death in the multivariable model was eGFR < 60 mL/min/m2 (4.621, p = 0.02), whereas SpO2 decreased the odds of death at baseline (0.479 per 5%, p = 0.002) and the use of remdesivir (0.425, p = 0.03). This study shows that patients with COVID-19 and malignancy benefit from early remdesivir therapy, resulting in a decrease in early mortality by 80%. The prognosis was worsened by low glomerular filtration rate and low peripheral oxygen saturation at baseline underlying the role of kidney protection and early hospitalization.

Inflammatory and thrombotic parameters associated with the COVID-19 course in Poland (SARSTer study).

PURPOSE: The aim of the study was to assess the coagulation and inflammatory markers connected with severe course of COVID-19 and no clinical improvement. MATERIAL AND METHODS: The study population included 2590 adult patients, diagnosed with COVID-19, selected from the SARSTer national database - an ongoing project led by the Polish Association of Epidemiologists and Infectiologists and supported by the Medical Research Agency. Clinical and laboratory parameters, such as C-reactive protein (CRP), white blood cells (WBCs), neutrophil and lymphocyte count, procalcitonin, ferritin, interleukin-6 (IL-6), D-dimer concentration and platelet (PLT) count were analyzed before and after treatment (remdesivir, tocilizumab, dexamethasone, anticoagulants). RESULTS: Significant differences between patients with mild and severe course of the disease were observed in all examined parameters before treatment (p â€‹< â€‹0.05). After treatment only ferritin concentration did not differ significantly. In patients with pulmonary embolism, CRP concentration, neutrophil count, D-dimer and IL-6 concentration were significantly higher than in patients without embolism (p â€‹< â€‹0.05). The significant differences between the groups with and without fatal outcome were observed within all analyzed parameters. Significant differences in all examined parameters before treatment were observed between patients with and without clinical improvement (p â€‹< â€‹0.05). Multivariate logistic regression showed that no clinical improvement was associated with: IL-6>100 â€‹pg/ml (OR-2.14), D-dimer concentration over 1000 â€‹ng/ml (OR-1.62) and PLT count below 150,000/µl (OR-1.57). CONCLUSIONS: Severe course of the disease is associated with lower PLT and lymphocyte count, higher D-dimer, CRP, neutrophil count and IL-6 concentration. The best predictors of no clinical improvement in COVID-19 are: IL-6>100 â€‹pg/ml, D-dimer>1000 â€‹ng/ml and PLT<150,000/µl.

Severe Breakthrough COVID-19 Cases during Six Months of Delta Variant (B.1.617.2) Domination in Poland.

The emergence of a highly transmissible and a more pathogenic B.1.617.2 (delta) variant of SARS-CoV-2 has brought concern over COVID-19 vaccine efficacy and the increased risk of severe breakthrough infections. The objective of this study was to assess the frequency and the clinical characteristics of severe breakthrough COVID-19 cases recorded in 10 Polish healthcare units between 1 June and 31 December 2021, a period during which a rapid surge in the share of B.1.617.2 infections was seen, while a significant number of populations were already fully vaccinated. Overall, 723 individuals who completed the initial vaccination regime (fully vaccinated group) and an additional 18 who received a booster dose were identified-together, they represented 20.8% of all the COVID-19 patients hospitalized during the same period in the same healthcare institutions (0.5% in the case of a group that received a booster dose). Although laboratory and clinical parameters did not differ between both groups, patients who received a booster tended to have lower CRP, IL-6, PCT, and d-dimer levels and they required oxygen therapy less frequently. The most common early COVID-19 symptoms in the studied group were fatigue, cough, fever (>38 °C), and dyspnea. Individuals with no detectable anti-spike IgG antibodies constituted 13%; the odds of being a humoral non-responder to the vaccine were increased in patients aged >70 years. Fully vaccinated patients hospitalized after more than 180 days from the last vaccine dose were significantly older and they were predominantly represented by individuals over 70 years and with comorbidities, particularly cardiovascular disease. Contrary to mRNA vaccines, most patients vaccinated with adenoviral vector vaccines were infected within six months. A total of 102 fatal cases (14% of all deaths among vaccinated individuals; 0.7% in the case of a group that received a booster dose) were recorded, representing 17.6% of all the COVID-19 fatalities recorded in June-December 2021 in the considered healthcare units. The odds of death were significantly increased in men, individuals aged >70 years, patients with comorbidities, and those identified as humoral non-responders to vaccination; in fully vaccinated patients the odds were also increased when the second vaccine dose was given >180 days before the first COVID-19 symptoms. The mortality rate in immunocompromised subjects was 19%. The results indicate that compared to vaccinated individuals, severe COVID-19 and deaths in the unvaccinated group were significantly more prevalent during the B.1.617.2-dominated wave in Poland; and, it highlight the protective role of a booster dose, particularly for more vulnerable individuals.

Management of SARS-CoV-2 infection: recommendations of the Polish Association of Epidemiologists and Infectiologists as of February 23, 2022.

The first Polish recommendations regarding the management of patients with COVID-19 were published by the Polish Society of Epidemiologists and Infectiologists (PTEiLChZ) on March 31, 2020, and the last annex was dated November 12, 2021. The ongoing state of pandemic, the emergence of new variants of the virus, and the availability of new drugs necessitate their updating. Changes introduced in the current version of recommendations for the management of COVID-19 comprised the possibility of using remedesivir in an outpatient setting, previously reserved for inpatient treatment, as well as other antiviral drugs-molnupiravir and nirmatrelvir / ritonavir. We revised the possibility of using monoclonal antibodies due to the resistance of the currently dominant Omicron variant. Anakinra, an antagonist of interleukin 1 receptors, has been added as a treatment option in advanced stages of the disease, and the recommended daily dose of glucocorticosteroids used in the most severe forms of COVID-19 has been increased. Information on vaccination and pre-exposure prophylaxis in specific populations has also been updated.

Analysis of the Dependence of Factors Influencing the Evaluation of Remote Work

Purpose: The aim of the article is to present in-depth results of the study, which was carried out to check the sense of health and general well-being of employees working at home. Design/Methodology/Approach: To achieve the goal, the respondents were asked about the approach of the management of organizations from various industries in terms of organizing work during the COVID-19 pandemic, and employees were also asked about their work from home, attitude to this type of work, their housing and other possibilities. The study was based on the CAWI computer-assisted diagnostic survey. The research tool was a self-questionnaire. The questionnaires in the period from 12 to 21 November 2020 were completed by 95 respondents aged 18 to 59. The basic results are presented in the article: "The impact of remote work on human well-being". Findings: As a result, it turned out that women more often feel the psychological and physical effects of a pandemic, and men are more unanimous in their indications (e.g., weight gain, mood drops, etc.). In addition, it turned out that employees of medium and large enterprises can count on the greatest support in the field of organizational changes. Practical Implications: The conclusions drawn based on the analyzes are a signpost for the individualization of solutions by organizations in supporting the achievement of a sense of mental and physical well-being of their employees Originality/Value: The research on impact of COVID-19 on well-being and comfort of employees have been conducted all over the world since the pandemic hit the world. Providing various perspectives, social and economical background can improve resilience of companies and economies in the future, disregarding the type and duration of crises to come.

The Impact of Remote Work on Human Well-Being

Purpose: The aim of the article is to present the results of the study that was planned and performed to check the sense of well-being of employees working at home. Design/Methodology/Approach: To this end, the approach of the management of organizations from various industries in terms of organizing work during the SARS-Cov2 pandemic was verified, and employees were asked about their work from home, attitude to this type of work, their housing and other possibilities. The study used the CAWI computer-assisted diagnostic survey method. The research tool was a self-questionnaire. The questionnaires in the period from 12 to 21 November 2020 were completed by a total of 95 respondents (77 women and 18 men) aged 18 to 59. Findings: The results, although statistically insignificant, showed that almost 75% of the respondents could work at home, but as many as 49% of respondents do not have a permanent place of work, but perform duties at home where it is possible. Despite the fact that the pandemic has forced the transfer of work home for fear of the safety of employees, this solution brings with it new problems in terms of ensuring the health and well-being of employees working remotely. Practical Implications: The conclusions drawn based on the analyzes support the search for a new path to support their employees' organizations in achieving a sense of mental and physical well-being. Originality/Value: This study is part of the research presented in two papers and exploring important and very topical problem of impact of pandemic on health and well-being.

Demographic and Clinical Overview of Hospitalized COVID-19 Patients during the First 17 Months of the Pandemic in Poland.

Long-term analyses of demographical and clinical characteristics of COVID-19 patients can provide a better overview of the clinical course of the disease. They can also help understand whether changes in infection symptomatology, disease severity, and outcome occur over time. We aimed to analyze the demographics, early symptoms of infection, laboratory parameters, and clinical manifestation of COVID-19 patients hospitalized during the first 17 months of the pandemic in Poland (March 2020-June 2021). The patients' demographical and clinical data (n = 5199) were extracted from the national SARSTer database encompassing 30 medical centers in Poland and statistically assessed. Patients aged 50-64 were most commonly hospitalized due to COVID-19 regardless of the pandemic period. There was no shift in the age of admitted patients and patients who died throughout the studied period. Men had higher C-reactive protein and interleukin-6 levels and required oxygenation and mechanical ventilation more often. No gender difference in fatality rate was seen, although the age of males who died was significantly lower. A share of patients with baseline SpO2 < 91%, presenting respiratory, systemic and gastrointestinal symptoms was higher in the later phase of a pandemic than in the first three months. Cough, dyspnea and fever were more often presented in men, while women had a higher frequency of anosmia, diarrhea, nausea and vomiting. This study shows some shifts in SARS-CoV-2 pathogenicity between March 2020 and July 2021 in the Polish cohort of hospitalized patients and documents various gender-differences in this regard. The results represent a reference point for further analyses conducted under the dominance of different SARS-CoV-2 variants.

Tocilizumab Improves the Prognosis of COVID-19 in Patients with High IL-6.

Despite direct viral effect, the pathogenesis of coronavirus disease 2019 (COVID-19) includes an overproduction of cytokines including interleukin 6 (IL-6). Therefore, tocilizumab (TOC), a monoclonal antibody against IL-6 receptors, was considered as a possible therapeutic option. Patients were selected from the SARSTer database, containing 2332 individuals with COVID-19. Current study included 825 adult patients with moderate to severe course. Analysis was performed in 170 patients treated with TOC and 655 with an alternative medication. The end-points of treatment effectiveness were death rate, need for mechanical ventilation, and clinical improvement. Patients treated with TOC were balanced compared to non-TOC regarding gender, age, BMI, and prevalence of coexisting conditions. Significant effect of TOC on death was demonstrated in patients with baseline IL-6 > 100 pg/mL (hazard ratio [HR]: 0.21, 95% confidence interval [CI]: 0.08-0.57). The best effectiveness of TOC was achieved in patients with a combination of baseline IL-6 > 100 pg/mL and either SpO2 ≤ 90% (HR: 0.07) or requiring oxygen supplementation (HR: 0.18). Tocilizumab administration in COVID-19 reduces mortality and speeds up clinical improvement in patients with a baseline concentration of IL-6 > 100 pg/mL, particularly if they need oxygen supplementation owing to the lower value of SpO2 ≤ 90%.

Effect of COVID-19 on Anti-S Antibody Response in Healthcare Workers Six Months Post-Vaccination.

The current study aimed to determine to what extent prior COVID-19 infection affects the response of specific antibodies following vaccination. The study involved 173 healthcare professionals who completed the two-dose vaccination course with BNT162b2, including 40 who previously experienced clinical COVID-19. The levels of anti-SARS-CoV-2 S1S2 IgG (anti-S) and, in some cases, anti-SARS-CoV-S-RBD IgG (anti-S-RBD) were determined six months after complete vaccination. A level exceeding the cut-off values for both anti-S and anti-S-RBD was observed in 100% of subjects, but after setting the analysis to 5- and 10-fold cut-off levels, the percentage of subjects meeting this criterion was significantly higher for anti-S-RBD. The 100-fold cut-off level was achieved by only 21% and 16% for anti-S and anti-S-RBD, respectively. Anti-S and anti-S-RBD levels above ten times the positive cut-off were respectively observed in 91% and 100% individuals with a history of COVID-19, while among those without COVID-19, these values were 64% and 90%, respectively. Significantly higher incidence of values above 10 and 100 times the cut-off became apparent among people with a history of COVID-19. In conclusion, vaccination against COVID-19 following infection with the disease provides higher levels of specific antibodies 6 months after vaccination than those of individuals without a history of the disease, which supports the use of a booster dose, particularly for those who have not experienced SARS-CoV-2 infection.

Effectiveness of Tocilizumab with and without Dexamethasone in Patients with Severe COVID-19: A Retrospective Study.

PURPOSE: The pathogenesis of coronavirus disease 2019 (COVID-19) is complicated, and in addition to antiviral therapy and combating coagulopathy, treatment should also include inhibition of the proinflammatory cytokines overproduction. The purpose of this study is to compare the effectiveness of tocilizumab (TCZ) and dexamethasone (DEX) administered alone or in combination in patients with severe COVID-19. PATIENTS AND METHODS: Patients were selected from the SARSTer database, containing 3330 individuals with COVID-19 treated between 1 March 2020 and 10 March 2021. The current study included adult patients with baseline oxygen saturation (SpO2) ≤90%, requiring regular or non-invasive high-flow oxygen supplementation. RESULTS: Among included 460 patients, 59 were treated with TCZ, 125 with TCZ and DEX, 169 with DEX, and 107 did not receive TCZ nor DEX. The groups were balanced regarding demographics, coexisting diseases, baseline SpO2, and comedications with remdesivir or low-molecular-weight heparin. The death rate of 6.8% was significantly lower in patients receiving TCZ alone than each arm (19.6%-23.1%), particularly in patients with interleukin-6 concentration exceeding 100pg/mL (5% vs 22.9%-51.7%, respectively). Analysis of clinical improvement demonstrated doubled, significantly higher rate after 21 and 28 days in patients treated with TCZ alone (60% and 75%, respectively) compared to DEX (27.6% and 37.9%, respectively). The need for mechanical ventilation was similar in all arms. CONCLUSION: In patients with severe course of COVID-19, particularly those developing cytokine storm, administration of TCZ provides a significantly better effect than DEX regarding survival, clinical improvement, and hospital discharge rate. The combination of TCZ and DEX does not improve therapy effectiveness in patients with severe COVID-19 compared to the administration of TCZ alone.

Impact of Kidney Failure on the Severity of COVID-19.

BACKGROUND: Patients with kidney failure are at an increased risk of progression to a severe form of coronavirus disease 2019 (COVID-19) with high mortality. The current analysis was aimed to assess the impact of renal failure on the severity of COVID-19 and identify the risk factors of the fatal outcome in this population. METHODS: The analysis included patients from the SARSTer database, a national real-world study evaluating treatment for COVID-19 in 30 Polish centers. Data were completed retrospectively and submitted online. RESULTS: A total of 2322 patients were included in the analysis. Kidney failure was diagnosed in 455 individuals (19.65%), of whom 373 presented moderate stage and 82 patients, including 14 dialysis individuals, presented severe renal failure. Patients with kidney failure were significantly older and demonstrated a more severe course of COVID-19. The age, baseline SpO2, the ordinal scale of 4 and 5, neutrophil and platelet count, estimated glomerular filtration rate, and C-reactive protein concentration as well as malignancy and arterial hypertension were the independent predictors of 28-day mortality in logistic regression analysis. CONCLUSIONS: Underlying kidney disease in patients with COVID-19 is among the leading factors associated with a higher risk of severe clinical presentation and increased mortality rate.

COVID-19 impact on perinatal care: risk factors, clinical manifestation and prophylaxis. Polish experts' opinion for December 2020.

Rapid spread of severe acute respiratory syndrome coranovirus-2 virus (SARS-CoV-2) caused the pandemic of Coronavirus Disease 19 (COVID-19). Clinical course of the disease presents symptoms mainly from the respiratory system such as: cough, dyspnea and fever, and among some patients, can deteriorate even further to acute respiratory distress syndrome (ARDS), eventually leading to death. This outbreak, as well as previous ones (SARS, MERS) pose a significant challenge for health care managers, epidemiologists and physicians. Below we are presenting the clinical profile of the COVID-19 among special group of patients; pregnant women and newborns, who require special clinical management during hospitalization. In the summary of this manuscript, we present practical guidelines for managing pregnant women infected with SARS-CoV-2, labor and care of the newborn of a positive mother, as well as practical guidelines for COVID-19 vaccinations. It is important to stress, that this manuscript is based on information available as of December 2020.

Tocilizumab for patients with severe COVID-19: a retrospective, multi-center study.

BACKGROUND: Tocilizumab, an inhibitor of the interleukin-6 receptor, may decrease the inflammatory response and control the symptoms of severe coronavirus disease 2019 (COVID-19), but the evidence is scarce. METHODS: This retrospective study included patients with severe COVID-19 requiring oxygen therapy who received tocilizumab in seven centers across Poland. We assessed on-treatment changes in clinical status and inflammatory markers. RESULTS: Twenty-eight patients were included (19 male), with a mean age of 61.7 ± 12.4 years. The mean time from symptom onset to the first tocilizumab dose was 10.5 ± 5.7 days. Clinical status improved within 24 hours in 11 (39%) patients, within one week in 23 (82%) patients, and within two weeks in 25 (89%); one (4%) patient showed no change and two (7%) patients died. Sixteen patients (57%) no longer needed oxygen therapy within a week (p < 0.001). The serum concentrations of C-reactive protein, procalcitonin, and fibrinogen decreased significantly (p ≤ 0.001). Lung changes improved in 21 (84%) patients within two weeks of treatment; 19 had minimal or no changes upon final examination. CONCLUSIONS: Tocilizumab can control the symptoms of severe COVID-19 by reducing the inflammatory response and rapidly improves the clinical status in most patients.