Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial.

Protective neutralizing antibody titers reduce in time after COVID-19 vaccinations, as in individuals who have had COVID-19. This study aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as a booster dose after CoronaVac primary vaccination. This double-blind, randomized, controlled, phase II, multicenter study included healthy male and female adults (18-60 years) who were vaccinated with two doses of CoronaVac vaccine and did not exceed the duration of at least 90 days and a maximum of 270 days from the second dose of vaccination. Among 236 eligible volunteers, 222 were recruited for randomization between July 12, 2021 and September 10, 2021; 108 and 114 were randomized to the TURKOVAC and CoronaVac arms, respectively. The primary endpoint was adverse events (AEs) (ClinicalTrials.gov; Identifier: NCT04979949). On day 28, at the neutralizing antibody threshold of 1/6, the positivity rate reached 100% from 46.2% to 98.2% from 52.6% in the TURKOVAC and CoronaVac arms, respectively, against the Wuhan variant and the positivity rate reached 80.6% from 8.7% in the TURKOVAC arm vs. 71.9% from 14.0% in the CoronaVac arm against the Delta variant. IgG spike antibody positivity rate increased from 57.3% to 98.1% and from 57.9% to 97.4% in the TURKOVAC and CoronaVac arms, respectively. The TURKOVAC and CoronaVac arms were comparable regarding the frequency of overall AEs. Both vaccines administered as booster yielded higher antibody titers with acceptable safety profiles.

What is the context? The timing of the primary and booster doses for each vaccine differs.We aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as homologous booster dose after CoronaVac primary vaccination.What is new? The neutralizing antibody titers against the Wuhan variant decreased below 1/6- the seropositivity threshold value- in more than 55% of the participants 4 months after administration of two doses of CoronaVac vaccine.Immunogenicity was re-stimulated and the neutralizing antibody titers increased rapidly and markedly with the administration of the CoronaVac or TURKOVAC as a booster dose 4 months after the second dose.While the increase in neutralizing antibodies against the Wuhan variant was similar with both CoronaVac and TURKOVAC, more antibodies developed against the Delta variant with TURKOVAC.What is the impact? With the Hybrid COV-RAPEL TR study, after the primary vaccination consisting of two doses of inactivated vaccine, antibody titers decreased in the long term; however, higher antibody titers are achieved than the primary vaccination after the booster dose administered after 4­6 month interval.Booster application with TURKOVAC provides antibodies at least as much as the CoronaVac booster dose, with an acceptable safety profile.

Effect of chronic lung diseases on mortality of prevariant COVID-19 pneumonia patients.

Background: The aim of the study is to assess the effect of chronic lung disease on mortality in patients hospitalized with the diagnosis of prevariant COVID-19 Pneumonia compared to patients without chronic lung disease. Research design and methods: A cohort of 1,549 patients admitted to the pandemic clinic with a COVID-19 Pneumonia diagnosis was analyzed. Group 1 and Group 2 were compared in terms of the treatment they received, admission to intensive care, mortality and follow-up parameters. Results: The patient group with COVID-19 and lung disease consisted of 231 participants (14.91%) (Group 1). The patient group with COVID-19 but without lung disease had 1,318 participants (85.19%). Group 1 cases were found to receive more oxygen therapy and mechanical ventilation than Group 2 cases (p ≤ 0.001), Following univariate and multiple logistic regression analyses, it was determined that patients with chronic lung disease had a 25.76% higher mortality risk [OR: 25.763, 95% CI (Lower-Upper) (2.445-271.465), p = 0.007]. Conclusion: It was found that chronic lung disease contributed significantly to mortality in this study. Among chronic lung diseases, Chronic Obstructive Pulmonary Disease (COPD), lung cancer and interstitial lung diseases (ILDs) were shown to be more effective than other chronic lung diseases in patients with prevariant COVID-19 population.

Comparison of anakinra and tocilizumab in management of severe COVID-19: a retrospective cohort study.

BACKGROUND: Studies regarding effectiveness of anakinra and tocilizumab treatments in coronavirus disease 2019 (COVID-19) have contradictory results. Furthermore, there is scarce comparative data regarding superiority of any agent. To further elucidate any superiority between these two agents, we retrospectively investigated and compared outcomes in hospitalized COVID-19 patients of our inpatient cohort who received anakinra or tocilizumab. METHODS: This study was designed as a single-center, retrospective, cross-sectional cohort study. Hospitalized patients with confirmed diagnosis of COVID-19 who had Brescia-COVID respiratory severity scale score ≥3 and hyperinflammation (defined as elevation of C reactive protein ≥50 g/L or ferritin ≥700 ng/mL) and received anakinra or tocilizumab in addition to standard care were enrolled in the study. Length of hospital stay after initiation of antiinflammatory treatment, need for mechanical ventilation, need for intensive care unit admission, mortality were set as primary outcomes and compared between tocilizumab and anakinra recipients after propensity score matching. RESULTS: One hundred and six patients were placed in each group after propensity score matching. In the anakinra group, relative risk reduction for intensive care unit admission was 50% when compared to the tocilizumab group and the number needed to treat to avert an intensive care unit admission was 3 (95% CI, 2-5). In terms of mortality, a 52% relative risk reduction was observed with anakinra treatment and the number needed to treat to avert an intensive care unit admission was 8 (95% CI, 4-50). Significantly more patients were observed to receive glucocorticoids in the anakinra group. DISCUSSION: Anakinra administration in severe COVID-19 patients was significantly associated with better survival and greater clinical improvement compared to the tocilizumab administration in our study. Increased rate of glucocorticoid use in the anakinra group might have contributed to better outcomes.

Modified Proline Metabolism and Prolidase Enzyme in COVID-19.

OBJECTIVE: The aim of the study was to evaluate proline metabolism in patients affected by COVID-19. MATERIALS AND METHODS: This case-control study consisted of 116 patients with COVID-19 and 46 healthy individuals. Tests related to proline metabolism (prolidase, proline, hydroxyproline, glutamic acid, manganese) and copper and zinc tests were analyzed. RESULTS: The levels of proline and hydroxyproline amino acids and the prolidase enzyme were found to be lower and glutamic acid was found to be higher in the COVID-19 group compared to the healthy group (P = .012, P < .001, P < .001, and P < .001, respectively). The copper/zinc ratio was higher in patients with COVID-19 than in healthy individuals (P < .001). Significant correlations were found between proline metabolism tests and inflammatory and hemostatic markers commonly used in COVID-19. CONCLUSION: The proline metabolic pathway was affected in COVID-19. Relationships between proline pathway-related tests and inflammatory/hemostatic markers supported the roles of proline metabolism in proinflammatory and immune response processes.

Reducing length of hospital stay with colchicine.

INTRODUCTION: Colchicine is an ancient agent with well-known anti-inflammatory effects and commonly used in treatment of hyperinflammatory conditions. It has been argued that colchicine could be an appropriate treatment option in COVID-19 to control hyperinflammatory response. Here in this study, we aimed to investigate the impact of colchicine on outcomes of COVID-19 in our inpatient cohort. METHODOLOGY: In this retrospective cohort study, hospitalized COVID-19 patients were investigated. Demographics, comorbidities, COVID-19 symptoms, laboratory findings on admission and discharge, baseline and seventh day oxygenation status, rates of mortality, intensive care unit admission, administration of other anti-inflammatory treatments and length of hospital stay were compared between patients who received standard of care medications and who received colchicine additionally. RESULTS: Three hundred and thirty-six patients were included in the study (171 standard of care, 165 standard of care plus colchicine). The median length of hospital stay in colchicine group was significantly shorter. Rates of admission to intensive care unit, anti-inflammatory treatment administration and mortality did not differentiate between standard of care and colchicine groups. However, reduced rates of mortality and ICU admission were observed in patients who received colchicine with a dose of 1 mg/day when compared to patients who received 0.5 mg/day. CONCLUSIONS: Our study demonstrated that COVID-19 patients who received colchicine in addition to standard of care had shorter hospital stay. Our results further support the use of colchicine in treatment of COVID-19, particularly with a dose of 1 mg/day.

Can Serum Endocan Levels be Used as an Early Prognostic Marker for Endothelial Dysfunction in COVID-19?

In this study, we aimed to investigate whether degree of pneumonia and COVID-19 prognosis are associated with serum endocan levels at the early stage, when vascular damage has started. Patients between the ages of 18-85 years who were hospitalized and followed up with a diagnosis of COVID-19 were included in the study. A total of 80 patients were divided into 2 groups as mild/moderate pneumonia and severe pneumonia. Serum endocan levels were measured on the 8th day from the onset of symptoms in all patients. Of the 80 patients included in the study, 56.3% were female and 43.8% were male. There was no significant relationship between serum endocan levels and degree of pneumonia (P = .220) and prognosis of the disease (P = .761). The correlation analysis indicated a weak positive correlation between serum endocan levels and lactate level in venous blood gas (r = .270; P = .037). During the 28-day follow-up, the mortality rate was 3.75%. It was determined that the serum endocan levels was not associated with the degree of pneumonia and was not an early prognostic marker for COVID-19.

Development and validation of nomogram to predict severe illness requiring intensive care follow up in hospitalized COVID-19 cases.

BACKGROUND: Early identification of severe COVID-19 patients who will need intensive care unit (ICU) follow-up and providing rapid, aggressive supportive care may reduce mortality and provide optimal use of medical resources. We aimed to develop and validate a nomogram to predict severe COVID-19 cases that would need ICU follow-up based on available and accessible patient values. METHODS: Patients hospitalized with laboratory-confirmed COVID-19 between March 15, 2020, and June 15, 2020, were enrolled in this retrospective study with 35 variables obtained upon admission considered. Univariate and multivariable logistic regression models were constructed to select potential predictive parameters using 1000 bootstrap samples. Afterward, a nomogram was developed with 5 variables selected from multivariable analysis. The nomogram model was evaluated by Area Under the Curve (AUC) and bias-corrected Harrell's C-index with 95% confidence interval, Hosmer-Lemeshow Goodness-of-fit test, and calibration curve analysis. RESULTS: Out of a total of 1022 patients, 686 cases without missing data were used to construct the nomogram. Of the 686, 104 needed ICU follow-up. The final model includes oxygen saturation, CRP, PCT, LDH, troponin as independent factors for the prediction of need for ICU admission. The model has good predictive power with an AUC of 0.93 (0.902-0.950) and a bias-corrected Harrell's C-index of 0.91 (0.899-0.947). Hosmer-Lemeshow test p-value was 0.826 and the model is well-calibrated (p = 0.1703). CONCLUSION: We developed a simple, accessible, easy-to-use nomogram with good distinctive power for severe illness requiring ICU follow-up. Clinicians can easily predict the course of COVID-19 and decide the procedure and facility of further follow-up by using clinical and laboratory values of patients available upon admission.

Which hematological markers have predictive value as early indicators of severe COVID-19 cases in the emergency department?

Background/aim: Coronavirus 2019 disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a pandemic infectious disease that causes morbidity and mortality. As a result of high mortality rate among the severe COVID-19 patients, the early detection of the disease stage and early effective interventions are very important in reducing mortality. Hence, it is important to differentiate severe and nonsevere cases from each other. To date, there are no proven diagnostic or prognostic parameters that can be used in this manner. Due to the expensive and not easily accessible tests that are performed for COVID-19, researchers are investigating some parameters that can be easily used. In some recent studies, hematological parameters have been evaluated to see if they can be used as predictive parameters. Materials and methods: In the current study, almost all hematological parameters were used, including the neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, monocyte/lymphocyte ratio, mean platelet volume to lymphocyte ratio, mean platelet volume to platelet ratio, plateletcrit, and D-dimer/fibrinogen ratio, neutrophil/lymphocyte/platelet scoring system, and systemic immune-inflammation index. A total of 750 patients, who were admitted to Ankara City Hospital due to COVID-19, were evaluated in this study. The patients were classified into 2 groups according to their diagnosis (confirmed or probable) and into 2 groups according to the stage of the disease (nonsevere or severe). Results: The values of the combinations of inflammatory markers and other hematological parameters in all of the patients with severe COVID-19 were calculated, and the predicted values of these parameters were compared. According to results of the study, nearly all of the hematological parameters could be used as potential diagnostic biomarkers for subsequent analysis, because the area under the curve (AUC) was higher than 0.50, especially for the DFR and NLR, which had the highest AUC among the parameters. Conclusion: Our findings indicate that, the parameters those enhanced from complete blood count, which is a simple laboratory test, can help to identify and classify COVID-19 patients into non-severe to severe groups.