Retrospective Analysis of the Effectiveness of Remdesivir in COVID-19 Treatment during Periods Dominated by Delta and Omicron SARS-CoV-2 Variants in Clinical Settings.

Continuous evaluation of real-world treatment effectiveness of COVID-19 medicines is required due to the ongoing evolution of SARS-CoV-2 and the possible emergence of resistance. Therefore, this study aimed to analyze, in a retrospective manner, the outcomes in patients hospitalized with COVID-19 during the pandemic waves dominated by Delta and Omicron variants and treated with remdesivir (RDV) (n = 762) in comparison to a demographically and clinically matched group not treated with any antivirals (n = 1060). A logistic regression analysis revealed that RDV treatment was associated with a significantly lower risk of death during both Delta wave (OR = 0.42, 95%CI: 0.29-0.60; p < 0.0001) and Omicron-dominated period (OR = 0.56, 95%CI: 0.35-0.92; p = 0.02). Moreover, RDV-treated groups were characterized by a lower percentage of patients requiring mechanical ventilation, but the difference was not statistically significant. This study is the first real-world evidence that RDV remains effective during the dominance of more pathogenic SARS-CoV-2 variants and those that cause a milder course of the disease, and continues to be an essential element of COVID-19 therapy.

Variability in the Clinical Course of COVID-19 in a Retrospective Analysis of a Large Real-World Database.

The COVID-19 pandemic proceeds in waves, with variable characteristics of the clinical picture resulting from the evolution of the SARS-CoV-2 virus. This study aimed to compare the epidemiological characteristics, symptomatology, and outcomes of the disease in patients hospitalized for COVID-19 during periods of different variants dominance. Comparing the periods of dominance of variants preceding the Delta variant, the Delta period was characterized by a higher share of hospitalized females, less frequent comorbidities among patients, and a different age distribution. The lowest need for oxygen therapy and mechanical ventilation was observed under Omicron dominance. The triad of classic COVID-19 symptoms, cough, fever, dyspnoea, and fatigue, were most prevalent during the Delta period, and significantly less common under the Omicron dominance. During the Omicron period, nearly twice as many patients as in the previous periods could be discharged from the hospital within 7 days; the overall 28-day mortality was significantly lower compared to that of the Delta period. It also did not differ between periods that were dominated by the BA.1 and BA.2 subvariants. The study indicates that the Omicron SARS-CoV-2 variant that dominated between January and June 2022 caused a disease which resembled the common cold, and was caused by seasonal alpha and beta-coronaviruses with a low pathogenicity for humans. However, one should note that this effect may not only have been related to biological features of the Omicron lineage, but may additionally have been driven by the increased levels of immunization through natural infections and vaccinations, for which we could not account for due to a lack of sufficient data.

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.

Differences between the course of SARS-CoV-2 infections in the periods of the Delta and Omicron variant dominance in Poland.

INTRODUCTION: Up to now, COVID­19 caused more than 6 million deaths worldwide. So far, 5 variants of concerns have been identified, with Delta and Omicron being the subject of our analysis. OBJECTIVES: We aimed to compare baseline characteristics and outcomes of patients hospitalized during the Delta and Omicron predominance in Poland. PATIENTS AND METHODS: The study population consisted of 2225 patients divided into 2 groups depending on the variant with which they were infected during the corresponding period of the pandemic. RESULTS: During the Delta wave, the median age of patients was significantly lower (65 vs 73 years; P <0.001), and the cohort was significantly less burdened with comorbidities than during the Omicron surge. The Omicron­infected patients presented significantly less often in an unstable symptomatic state with SpO2 equal to or below 90% on admission (49.9% for Delta vs 29.9% for Omicron; P <0.001). Regardless of the pandemic period, the 2 most common early symptoms of COVID­19 were fever and cough. In­hospital treatment consisted of antiviral drugs, more frequently used in the Omicron wave, and immunomodulatory drugs, more frequently used during the Delta wave. The risk of mechanical ventilation was significantly lower in the patients infected with the Omicron variant (7.2% for Delta vs 3.1% for Omicron; P <0.001). For the age group above 80 years old, the risk of death was significantly higher during the Delta wave than during the Omicron wave. The risk of death was significantly lower in the patients treated with antiviral drugs regardless of the pandemic wave. CONCLUSIONS: The Delta variant is associated with a more severe clinical course of the disease and a higher risk of death than the Omicron variant.

The Course of COVID-19 in Patients with Systemic Autoimmune Rheumatic Diseases.

Patients with systemic autoimmune rheumatic disease (SARD) have increased susceptibility to viral infections, including SARS-CoV-2. The aim of this study was to analyse the SARD patient population with COVID-19 (coronavirus disease 2019) in terms of baseline characteristics, severity, course and outcomes of the disease compared with the non-SARD group, and to identify factors associated with prognosis, including remdesivir therapy efficacy. Retrospective study comprised 8220 COVID-19 cases from the SARSTer database, including 185 with SARD. Length of hospitalisation, duration of oxygen therapy, mortality and the need for HFNO (high-flow nasal oxygen) and/or NIV (noninvasive ventilation) were significantly higher in the SARD versus non-SARD group. There was no difference in clinical features on admission to hospital. Patients with SARD were older and more likely to have cardiovascular, pulmonary and chronic kidney diseases. Age, the presence of cardiovascular disease, more severe conditions on admission and higher inflammatory marker values were found to be risk factors for death in the SARD group. In patients with SARD treated with remdesivir, there was a trend towards improved mortality but without statistical significance. Length of hospitalisation, 28-day mortality and the need for HFNO and/or NIV were higher in the SARD group. These patients often had other chronic diseases and were older.

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.

Clinical studies of detecting COVID-19 from exhaled breath with electronic nose.

The COVID-19 pandemic has attracted numerous research studies because of its impact on society and the economy. The pandemic has led to progress in the development of diagnostic methods, utilizing the polymerase chain reaction (PCR) as the gold standard for coronavirus SARS-CoV-2 detection. Numerous tests can be used at home within 15 min or so but of with lower accuracy than PCR. There is still a need for point-of-care tests available for mass daily screening of large crowds in airports, schools, and stadiums. The same problem exists with fast and continuous monitoring of patients during their medical treatment. The rapid methods can use exhaled breath analysis which is non-invasive and delivers the result quite fast. Electronic nose can detect a cocktail of volatile organic com-pounds (VOCs) induced by virus infection and disturbed metabolism in the human body. In our exploratory studies, we present the results of COVID-19 detection in a local hospital by applying the developed electronic setup utilising commercial VOC gas sensors. We consider the technical problems noticed during the reported studies and affecting the detection results. We believe that our studies help to advance the proposed technique to limit the spread of COVID-19 and similar viral infections.

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.

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.

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.

Convalescent Plasma Transfusion for the Treatment of COVID-19-Experience from Poland: A Multicenter Study.

Because the optimal treatment for COVID-19 is still unknown, it is important to explore every potential way of improving the chances of survival for COVID-19 patients. The aim of the study was to analyze the effectiveness of convalescent plasma on COVID-19 patients. The study population consisted of 78 patients diagnosed with COVID-19, selected from the SARSTer national database, who received convalescent plasma. The impact on clinical and laboratory parameters was assessed. A clinical improvement was observed in 62 (79%) patients, and 10 (13%) patients died from COVID-19. No side effects of the convalescent plasma treatment were observed. When plasma was administered earlier than 7 days from diagnosis, the total hospitalization time was shorter (p < 0.05). Plasma efficacy was inferior to remdesivir in endpoints such as the necessity and duration of oxygen therapy, the duration of hospitalization, and mortality rate, and inferior to other drugs in the case of the duration of hospitalization and the necessity of constant oxygen therapy, but comparable in most other measured endpoints. A comparison of a 30-day mortality rate in patients who received plasma and remdesivir (4/25, 16%) and who received only plasma (6/53, 11%) showed no significant difference. Convalescent plasma efficacy is inferior to remdesivir when treating COVID-19 patients but the addition of remdesivir to plasma does not improve the treatment effectiveness. In most endpoints, plasma was comparable to other treatment options. In our opinion, convalescent plasma may be used as a supportive treatment in COVID-19 patients because of the low frequency of adverse effects and availability, but must be given as early from the diagnosis as possible.

Convalescent Plasma Transfusion for the Treatment of COVID-19—Experience from Poland: A Multicenter Study

Because the optimal treatment for COVID-19 is still unknown, it is important to explore every potential way of improving the chances of survival for COVID-19 patients. The aim of the study was to analyze the effectiveness of convalescent plasma on COVID-19 patients. The study population consisted of 78 patients diagnosed with COVID-19, selected from the SARSTer national database, who received convalescent plasma. The impact on clinical and laboratory parameters was assessed. A clinical improvement was observed in 62 (79%) patients, and 10 (13%) patients died from COVID-19. No side effects of the convalescent plasma treatment were observed. When plasma was administered earlier than 7 days from diagnosis, the total hospitalization time was shorter (p <0.05). Plasma efficacy was inferior to remdesivir in endpoints such as the necessity and duration of oxygen therapy, the duration of hospitalization, and mortality rate, and inferior to other drugs in the case of the duration of hospitalization and the necessity of constant oxygen therapy, but comparable in most other measured endpoints. A comparison of a 30-day mortality rate in patients who received plasma and remdesivir (4/25, 16%) and who received only plasma (6/53, 11%) showed no significant difference. Convalescent plasma efficacy is inferior to remdesivir when treating COVID-19 patients but the addition of remdesivir to plasma does not improve the treatment effectiveness. In most endpoints, plasma was comparable to other treatment options. In our opinion, convalescent plasma may be used as a supportive treatment in COVID-19 patients because of the low frequency of adverse effects and availability, but must be given as early from the diagnosis as possible.