Evaluation of the Prevalence and Laboratory Test Results of Overt Thyrotoxicosis Cases.

BACKGROUND: The frequency of thyrotoxicosis may vary between countries and some laboratory test results may be used in etiology research. This study aimed to evaluate the prevalence of thyrotoxicosis diagnoses and laboratory test results. METHODS: 3246 patients with overt thyrotoxicosis were included in this study. Laboratory test results, epicrisis, thyroid ultrasonography, thyroid scintigraphy, and radioactive iodine uptake test reports of the patients were examined in the study. RESULTS: Thyrotoxicosis was found due to levothyroxine overdose in 58.1% of the patients. When this group was excluded, 36.1% of the patients were diagnosed with toxic multinodular goiter most frequently. TRab levels were 8.5 times higher in Graves' disease than in other diagnostic groups. Anti-TPO levels were found to be the highest in the Graves' disease and Hashitoxicosis groups compared to other diagnostic groups (p<0.001). Anti-Tg levels were found to be highest in Graves' disease, Postpartum thyroiditis, and Hashitoxicosis patients (p<0.001). The free triiodothyronine / free thyroxine ratio was significantly higher, a cut-off value of >2.94 provided a sensitivity of 66% and specificity of 64% in diagnosing Graves' disease. CONCLUSION: The causes of thyrotoxicosis show some differences between countries. Patients using levothyroxine should be informed about drug use and dose titration. The free triiodothyronine / free thyroxine ratio can be used in addition to other tests during diagnosis.

Long-Term Immunogenicity and Safety of a Homologous Third Dose Booster Vaccination with TURKOVAC: Phase 2 Clinical Study Findings with 32-Week Post-Booster Follow-Up.

Vaccine-induced immunity wanes over time and warrants booster doses. We investigated the long-term (32 weeks) immunogenicity and safety of a third, homologous, open-label booster dose of TURKOVAC, administered 12 weeks after completion of the primary series in a randomized, controlled, double-blind, phase 2 study. Forty-two participants included in the analysis were evaluated for neutralizing antibodies (NAbs) (with microneutralization (MNT50) and focus reduction (FRNT50) tests), SARS-CoV-2 S1 RBD (Spike S1 Receptor Binding Domain), and whole SARS-CoV-2 (with ELISA) IgGs on the day of booster injection and at weeks 1, 2, 4, 8, 16, 24, and 32 thereafter. Antibody titers increased significantly from week 1 and remained higher than the pre-booster titers until at least week 4 (week 8 for whole SARS-CoV-2) (p < 0.05 for all). Seroconversion (titers ≥ 4-fold compared with pre-immune status) persisted 16 weeks (MNT50: 6-fold; FRNT50: 5.4-fold) for NAbs and 32 weeks for S1 RBD (7.9-fold) and whole SARS-CoV-2 (9.4-fold) IgGs. Nine participants (20.9%) tested positive for SARS-CoV-2 RT-PCR between weeks 8 and 32 of booster vaccination; none of them were hospitalized or died. These findings suggest that boosting with TURKOVAC can provide effective protection against COVID-19 for at least 8 weeks and reduce the severity of the disease.

Three Simple Parameters on Admission to the Emergency Department are Predictors for Endoscopic Intervention in Patients with Suspected Nonvariceal Upper Gastrointestinal Bleeding.

BACKGROUND: A considerable number of patients with nonvariceal upper gastrointestinal bleeding (UGIB) need endoscopic intervention. OBJECTIVE: The aim of this study was to determine factors that predict the need for endoscopic intervention at the time of admission to the emergency department. METHODS: Consecutive patients with International Classification of Diseases, Tenth Revision diagnosis code K92.2 (gastrointestinal hemorrhage) who underwent upper endoscopy between February 2019 and February 2022, including patients diagnosed with nonvariceal UGIB in the emergency department in the study were reviewed retrospectively. The patients were divided into two groups: those treated endoscopically and those not treated endoscopically. These two groups were compared according to clinical and laboratory findings at admission and independent predictors for endoscopic intervention were determined using multivariate regression analysis. RESULTS: Although 123 patients (30.3%) were treated endoscopically, endoscopic treatment was not required in 283 (69.7%) patients. Syncope, mean arterial pressure (MAP), and blood urea nitrogen (BUN) at admission were independent predictors for endoscopic intervention in the multivariate analysis, after adjusting for endoscopy time. The area under the curve of the syncope+MAP+BUN combination for endoscopic intervention was 0.648 (95% CI 0.588-0.708). Although the syncope+MAP+BUN combination predicted the need for intervention significantly better than pre-endoscopy Rockall and AIMS65 scores (p = 0.010 and p < 0.001, respectively), there was no significant difference in its comparison with the Glasgow-Blatchford score (p = 0.103). CONCLUSIONS: Syncope, MAP, and BUN at admission were independent predictors for endoscopic therapy in patients with nonvariceal UGIB. Rather than using complicated scores, it would be more practical and easier to predict the need for endoscopic intervention with these three simple parameters, which are included in the Glasgow-Blatchford score.

The red cell distribution width-to-albumin ratio: A simple index has high predictive accuracy for clinical outcomes in patients with acute pancreatitis.

BACKGROUND/OBJECTIVES: Ongoing research is seeking to identify the best prognostic marker for acute pancreatitis (AP). The purpose of this study was to investigate the role of the red blood cell distribution width-to-albumin ratio (RAR) in the prognosis of AP. METHODS: This 18-month prospective cohort study was conducted between June 2021 and December 2022 with patients diagnosed with AP. The patients were divided into two groups: severe AP (SAP) and non-severe AP. Factors associated with SAP within the first 48 h of admission were determined. In addition, RAR values at admission and at 48 h (RAR-48th) were calculated, and their ability to predict clinical outcomes was assessed. The primary outcomes were severe disease and in-hospital mortality. RESULTS: Fifty (13.7 %) of 365 patients had SAP. Systemic inflammatory response syndrome, blood urea nitrogen, calcium, and RAR at 48 h after admission were independent predictors of SAP. When RAR-48th was >4.35, the risk of SAP increased approximately 18-fold (OR: 18.59; 95 % CI: 8.58-40.27), whereas no patients with a RAR-48th value of <4.6 died. For in-hospital mortality, the area under the curve (AUC) value of RAR-48th was 0.960 (95 % CI: 0.931-0.989), significantly higher than the AUC values of existing scoring systems. The results of RAR-48th were comparable to those of the other scoring systems with regard to the remaining clinical outcomes. CONCLUSIONS: RAR-48th successfully predicted clinical outcomes, particularly in-hospital mortality. Being simple and readily calculable, RAR-48th is a promising alternative to burdensome and complex scoring systems for the prediction of clinical outcomes in AP.

Poncet's disease and tubal tuberculosis: A case report.

A 25-year-old female patient was admitted to the hospital with abdominal pain, loss of appetite, and weight loss for the last 5 months. The patient underwent paracentesis five times and was referred to our clinic after peritonitis findings were detected. Tubal tuberculosis was detected during her hospitalization. The patient, who also developed joint pain, was diagnosed with Poncet's disease. She was given quadruple antituberculosis treatment. After the treatment, the patient's joint pain regressed, and the adnexal mass due to tubal tuberculosis disappeared. In this case report, we wanted to present a rare case of Poncet's disease with tubal tuberculosis.

Impact of Inflammation-Related Genes on COVID-19: Prospective Study at Turkish Cohort.

The pandemic coronavirus disease 2019 (COVID-19) has caused a high mortality rate and poses a significant threat to the population. The disease may progress with mild symptoms or may cause the need for intensive care, depending on many factors. In this study, it was aimed to determine if there is a tendency due to genetic factors in COVID-19 patients. Ninety-four of 188 patients with mild clinical and 94 with severe clinical symptoms were included in the study. The targeted panel including coagulopathy (F2, F5), viral invasion (ACE2), and inflammation (CXCL8, IFNAR2, IFNL4, IL10, IL2, IL6, IRF7, TLR3, TLR7, TNF) related genes was performed sequenced by the next generation sequencing (NGS). The variants found were classified and univariate analyses were performed to select candidate variables for logistic model. Risk factors and variants were compared. It was revealed that the presence of 2 or more risk factors caused the disease to progress severely (p < 0.001). Heterozygous IRF7:c.1357-23dup variant had a 2.5 times higher risk for mild disease compared to severe disease. Other variants were found to be more significant in mild disease. Since polymorphic variants were not evaluated in the literature, the findings of our study could not be compared with the literature. However, as variants that may be effective in the severity of infections may differ according to ethnicity. This study has the feature of being a guide for subsequent studies to be carried out especially in Turkish population. Clinical course of the COVID-19 is likely to depend on a variety of risk factors, including age, sex, clinical status, immunology and genetic factors.

Red cell distribution width-to-albumin ratio is a simple promising prognostic marker in acute cholangitis requiring biliary drainage.

BACKGROUND: It is crucial to assess the severity of acute cholangitis (AC). There are currently several prognostic markers. However, the accuracies of these markers are not satisfied. The present study aimed to investigate the predictive value of the red cell distribution width (RDW)-to-albumin ratio (RAR) for the prognosis of AC. METHODS: We retrospectively evaluated consecutive patients diagnosed with AC between May 2019 and March 2022. RAR was calculated, and its predictive ability for in-hospital mortality, intensive care unit (ICU) admission, bacteremia, and the length of hospitalization were analyzed. RESULTS: Out of 438 patients, 34 (7.8%) died. Multivariate analysis showed that malignant etiology [odds ratio (OR) = 4.816, 95% confidence interval (CI): 1.936-11.980], creatinine (OR = 1.649, 95% CI: 1.095-2.484), and RAR (OR = 2.064, 95% CI: 1.494-2.851) were independent risk factors for mortality. When adjusted for relevant covariates, including age, sex, malignant etiology, Tokyo severity grading (TSG), Charlson comorbidity index, and creatinine, RAR significantly predicted mortality (adjusted OR = 1.833, 95% CI: 1.280-2.624). When the cut-off of RAR was set to 3.8, its sensitivity and specificity for mortality were 94.1% and 56.7%, respectively. Patients with an RAR of > 3.8 had a 20.9-fold (OR = 20.9, 95% CI: 4.9-88.6) greater risk of mortality than the remaining patients. The area under the curve value of RAR for mortality was 0.835 (95% CI: 0.770-0.901), which was significantly higher than that of TSG and the other prognostic markers, such as C-reactive protein-to-albumin ratio, and procalcitonin-to-albumin ratio. Lastly, RAR was not inferior to TSG in predicting ICU admission, bacteremia, and the length of hospitalization. CONCLUSIONS: RAR successfully predicted the in-hospital mortality, ICU admission, bacteremia, and the length of hospitalization of patients with AC, especially in-hospital mortality. RAR is a promising marker that is more convenient than TSG and other prognostic markers for predicting the prognosis of patients with AC.

Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study.

The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines were used as a booster after the second dose of primary vaccination with CoronaVac. A total of 190 participants from the Hybrid COV-RAPEL TR Study, who had both Day 28 and Day 84 immunogenicity results, were included. The immunogenicity on Day 84, regarding the neutralizing antibody positivity (Wuhan and Delta variants) and anti-spike immunoglobulin (Ig) G (IgG) antibody positivity, was compared between TURKOVAC and CoronaVac vaccine arms according to sex and age groups. Overall, antibody positivity showed a slight decrease on Day 84 vs. Day 28, but was not different between TURKOVAC and CoronaVac arms either for sexes or for age groups. However, TURKOVAC produced better antibody response against the Delta variant than CoronaVac, while CoronaVac was superior over TURKOVAC regarding neutralizing antibody positivity in the 50-60 years age group, regardless of the variant. A single booster dose, after the completion of the primary vaccination, increases antibody positivity on Day 28 which persists until Day 84 with a slight decrease. However, an additional booster dose may be required thereafter, since the decrease in antibody titer may be faster over time.

Is eGFR ≥60 mL/min/1.73 m2 in Patients Undergoing Coronary Angiography Really Safe for Contrast Nephropathy?

The aim of the present study was to define the risk factors associated with contrast-induced acute kidney injury (CI-AKI) in patients who underwent coronary artery angiography (CAG). In this retrospective cohort study, patients who underwent CAG between March 2014 and January 2022 were evaluated. A total of 2923 eligible patients were included in the study. Univariate and multivariate logistic regression analysis was used to identify the predictive factors. CI-AKI developed in 77 (2.6%) of 2923 patients. In multivariate analysis, diabetes mellitus (DM), chronic kidney disease (CKD), and estimated glomerular filtration rate (eGFR) were found to be independent factors associated with CI-AKI. In the subgroup analysis of patients with eGFR ≥60 mL/min/1.73 m2, eGFR remained a predictor of CI-AKI (Odds ratio (OR): .89, 95% CI: .84-.93; that is, a lower eGFR remains a risk factor for CI-AKI). In the receiving operating characteristic (ROC) analysis of patients with eGFR ≥60 mL/min/1.73 m2, the area under the curve of the eGFR was .826. Using the ROC curve based on Youden's index, the eGFR cut-off was found to be 70 mL/min/1.73 m2 for patients with eGFR ≥60 mL/min/1.73 m2. eGFR is also an important risk factor in patients with eGFR 60-70 mL/min/1.73 m2.

Adverse outcomes and maternal complications in pregnant women with severe-critical COVID-19: a tertiary center experience.

OBJECTIVES: This study aimed to present perinatal outcomes, clinical challenges, and basic ICU management in pregnant women with severe-critical COVID-19 at our tertiary referral center. METHODS: In this prospective cohort study, patients were divided into two groups, whether they survived or not. Clinical characteristics, obstetric and neonatal outcomes, initial laboratory test results and radiologic imaging findings, arterial blood gas parameters at ICU admission, and ICU complications and interventions were compared between groups. RESULTS: 157 of the patients survived, and 34 of the patients died. Asthma was the leading health problem among the non-survivors. Fifty-eight patients were intubated, and 24 of them were weaned off and discharged healthfully. Of the 10 patients who underwent ECMO, only 1 survived (p<0.001). Preterm labor was the most common pregnancy complication. Maternal deterioration was the most common indication for a cesarean section. Higher neutrophil-to-lymphocyte-ratio (NLR) values, the need for prone positioning, and the occurrence of an ICU complication were important parameters that influenced maternal mortality (p<0.05). CONCLUSIONS: Overweight pregnant women and pregnant women with comorbidities, especially asthma, may have a higher risk of mortality related to COVID-19. A worsening maternal health condition can lead to increased rates of cesarean delivery and iatrogenic prematurity.

Characteristics and clinical outcomes of acute cholangitis in older patients.

PURPOSE: Few studies are available on older patients with acute cholangitis. In this study, we aimed to examine the clinical characteristics of older patients with acute cholangitis. METHODS: Patients aged 65 years and over who were diagnosed with acute cholangitis between February 2019 and August 2022 were analyzed retrospectively. Patients eligible for the study were divided into two groups as those aged ≥ 80 years (octogenarian) and those aged 65-79 years (non-octogenarian). These two groups were then compared for many clinical characteristics. In addition, factors associated with in-hospital mortality were identified. Finally, a subgroup analysis was performed in patients with non-malignant etiology. RESULTS: Of a total of 309 enrolled patients, 120 (38.8%) were in the octogenarian group and 189 (61.2%) were in the non-octogenarian group. The mean age was 77.2 ± 8.0 years and 51.8% were women. Severe disease and intensive care unit admission rates were higher in the octogenarian group (p = 0.035 and p = 0.002, respectively), but there was no significant difference in the rate of in-hospital mortality (p = 0.146). Malignant etiology (OR 2.990, 95% CI 1.131-7.904) and hypoalbuminemia (OR 0.824, 95% CI 0.751-0.903) were independent risk factors for in-hospital mortality. In the subgroup analysis of non-malignant etiology, the octogenarian group had a significantly higher in-hospital mortality rate than the non-octogenarian group (8.8% vs. 3.2%, p = 0.048). CONCLUSIONS: Among older patients with acute cholangitis, clinicians should closely monitor those aged 80 years and over, as well as those with malignant etiology and hypoalbuminemia, due to their high risk of serious clinical events.

Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye.

BACKGROUND/OBJECTIVE(S)/INTRODUCTION: TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine, which was developed and recently granted emergency use authorization (conditional marketing authorization) in Türkiye. The objective of this study is to assess the spectrum and the distribution of adverse events reported following the administration of the first 150,000 doses as primary and booster vaccine doses in 22 state hospitals of 17 provinces in Türkiye. PATIENTS/MATERIALS AND METHODS: In this cohort study, a verbal survey was conducted via telephone calls between 10 January and 17 January 2022, utilizing a structured questionnaire algorithm on a sample group of 20,000 persons on the third- and seventh-days following vaccination. The algorithm consisted of two parts focusing on both systemic and local adverse effects. Other adverse events reported by the participants were also recorded. 6023 people and 5345 people agreed to participate in the telephone survey on the 3rd- and 7th- days of having received the first dose of the vaccine, respectively. RESULTS: Thirty-six-point-six percent of the participants on the 3rd day and 22.5% of the participants on the 7th day reported any adverse event following the first dose of the vaccine. On both follow-up days, the most commonly reported (29.7% for Day 3 and 13.1% for Day 7) adverse events were on the injection site. Among the local adverse events, the most frequently reported one was the pain on the injection site (27.9% for Day 3 and 12.4% for Day 7), induration (4.8% for Day 3 and 2.7% for Day 7) and swelling (3.5% for Day 3 and 2.0% for Day 7). Fatigue/weakness (9.6% for Day 3 and 8.3% for Day 7) and headache (7.9% for Day 3 and 8.0% for Day 7) were the most frequent systemic adverse events. Younger age, vaccine dose, and female sex were associated with having any adverse event and pain (on the injection site). Female sex was associated with more swelling (on the injection site), induration (on the injection site), fever, and a higher impact on daily living. CONCLUSION(S): In this study, we conducted a rapid assessment of adverse events following the first dose of the TURKOVAC vaccine. The vaccine appears to have a good safety profile in the first 7 days following vaccination. Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines.

The role of irisin and asprosin level in the pathophysiology of prediabetes.

PURPOSE: We aimed to examine whether irisin and asprosin have a role in the physiopathology of prediabetes. METHODS: Hundred people were selected between the age of 18-65 years for the study population (60 prediabetes, 40 healthy). For the follow-up study, the patients with prediabetes were offered a 3-month program for lifestyle change and then reevaluated. Our research is a single-center, prospective observational study. RESULTS: Among the healthy group and patients with prediabetes, irisin levels were lower and asprosin levels were higher (p < 0.001) in patients. In the follow-up part, the patients' insulin levels, HOMA index scores, and asprosin levels were decreased while irisin levels were elevated (p < 0.001). Sensitivity was 98.3% and specificity was 65% for asprosin of > 56.3 ng/mL, while they were 93.3% and 65% for irisin of ≤ 120.2 pg/mL, respectively. It was found that irisin had diagnostic performance similar to insulin and the HOMA index, while asprosin performed similarly to glucose, insulin, and the HOMA index. CONCLUSION: Both irisin and asprosin have been found to be related to the prediabetes pathway and it has been shown that these molecules may be useful in daily clinical practice with diagnostic performances similar to those of the HOMA index and insulin.

Self-Reported Allergic Adverse Events Following Inactivated SARS-CoV-2 Vaccine (TURKOVAC™) among General and High-Risk Population.

TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine which was developed and granted emergency use and conditional marketing authorization in December 2021 in Türkiye. The objective of this study is to assess the distribution and the severity of allergic adverse events following the administration of the vaccine as the primary or the booster dose in 15 provinces in Türkiye. In this cohort study, between February and May 2022, in the selected 15 provinces having an adequate number of health care personnel in the community health centers to conduct the study, 32,300 people having the first, the second, or the booster dose of the vaccine were invited to the survey. A total of 29,584 people voluntarily agreed to participate to the survey and were given a structured questionnaire after a minimum of 10 days following the vaccination. In our study, only 0.5% of the participants (142 persons) reported to experience any allergic reaction, and 12 of them (8.5%) reported to be given medical treatment in a health center. Male predominance (55.6%) was observed among participants reported to experience any allergic reaction. No hospitalization was recorded. Of the participants, 4.4% (1315 people) reported to have a history of allergy. The most reported allergens were drugs. Among the participants without a known history of allergy (n = 28,269), 0.4% of them (110 people) reported to experience an allergic reaction following the vaccination, and 5.4% of the allergic reactions (six people) were reported to be treated in a health center. The percentage of the participants given any medical treatment among the participants without a known history of allergy is 0.02%. No immediate or anaphylactic reaction was reported. Among the participants with a known history of allergy (n = 1315), 32 people (2.4% of them) reported to experience an allergic reaction following the vaccination, and 18.7% of the allergic reactions (six people) were reported to be prescribed a medical treatment. The percentage of the participants given any medical treatment among the participants with a known history of allergy is 0.4%. A known history of allergy increased the risk of having an allergic experience by approximately six times following vaccination. As a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, with a low allergic reaction-related adverse event profile, can be an alternative to other COVID-19 vaccines.

Revisiting the Ranson score in acute pancreatitis: Is the drop in hematocrit a worrisome sign?

BACKGROUND: The Ranson score has 11 parameters that are complex and laborious to implement. In this study, we aimed to create a revised Ranson score by modifying the parameters in Ranson. METHODS: A total of 938 patients diagnosed with acute pancreatitis (AP) between 2014 and 2021 were included in the study. The parameters of the Ranson score were included in the univariate and multivariate analyses. According to the results, some of these parameters were modified, and then the revised Ranson score was created. RESULTS: The revised Ranson system was created with nine parameters by modifying the hematocrit parameter at 48 hours and excluding the aspartate aminotransferase parameter from the scoring system. For in-hospital mortality, the area under the curve value of the revised Ranson was 0.959 (95% CI: 0.931-0.986), and it was significantly higher compared to the three scoring systems evaluated. At a cut-off value of 3.5, the revised Ranson had a sensitivity and specificity of 91.7% and 89.1%, respectively, for mortality. CONCLUSION: The revised Ranson scoring system had better predictive ability for all clinical outcomes compared to the original Ranson in our large sample of 938 patients. However, the revised version should be further validated by prospective and multicenter studies.

The utility of systemic immune-inflammation index and systemic immune-response index in the prediction of adverse outcomes in pregnant women with coronavirus disease 2019: Analysis of 2649 cases.

AIM: To investigate the association of systemic immune-inflammation index (SII) and systemic immune-response index (SIRI) with adverse perinatal outcomes in pregnant women with coronavirus disease 2019 (COVID-19). METHODS: The cases were divided into (1) the Mild-moderate COVID-19 group (n = 2437) and (2) the Severe-critical COVID-19 group (n = 212). Clinical characteristics, perinatal outcomes, SII (neutrophilXplatelet/lymphocyte), and SIRI (neutrophilXmonocyte/lymphocyte) were compared between the groups. Afterward, SII and SIRI values were compared between subgroups based on pregnancy complications, neonatal intensive care unit (NICU) admission, and maternal mortality. A receiver operator characteristic analysis was performed for the determination of optimal cutoff values for SII and SIRI in the prediction of COVID-19 severity, pregnancy complications, NICU admission, and maternal mortality. RESULTS: Both SII and SIRI were significantly higher in complicated cases (p < 0.05). Cutoff values in the prediction of severe-critical COVID-19 were 1309.8 for SII, and 2.3 for SIRI. For pregnancy complications, optimal cutoff values were 973.2 and 1.6. Cutoff values of 1045.4 and 1.8 were calculated for the prediction of NICU admission. Finally, cut-off values of 1224.2 and 2.4 were found in the prediction of maternal mortality. CONCLUSION: SII and SIRI might be used in combination with other clinical findings in the prediction of poor perinatal outcomes.

Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials.

BACKGROUND: Development of safe and effective vaccine options is crucial to the success of fight against COVID-19 pandemic. Herein, we report interim safety and immunogenicity findings of the phase 1&2 trials of ERUCoV-VAC, an inactivated whole virion SARS-CoV-2 vaccine. METHODS: Double-blind, randomised, single centre, phase 1 and 2 trials included SARS-CoV-2 seronegative healthy adults aged 18-55 years (18-64 in phase 2). All participants, except the first 4 in phase 1 who received ERUCoV-VAC 3 µg or 6 µg unblinded and monitored for 7 days for safety purposes, were assigned to receive two intramuscular doses of ERUCoV-VAC 3 µg or 6 µg (an inactivated vaccine containing alhydrogel as adjuvant) or placebo 21 days apart (28 days in phase 2) according to computer-generated randomisation schemes. Both trials are registered at ClinicalTrials.gov (phase 1, NCT04691947 and phase 2, NCT04824391). RESULTS: Forty-four participants (3 µg [n:17], 6 µg [n:17], placebo [n:10]) in phase 1 and 250 (3 µg [n:100], 6 µg [n:100], placebo [n:50]) in phase 2 received ≥1 dose. In phase 1 trial, 25 adverse events AEs (80 % mild) occured in 15 participants (34.1 %) until day 43. There was no dose-response relationship noted in safety events in ERUCoV-VAC recipients (p = 0.4905). Pain at injection site was the most common AE (9/44;20.5 %). Both doses of ERUCoV-VAC 3 µg and 6 µg groups were comparable in inducing SARS-CoV-2 wild-type neutralising antibody (MNT50): GMTs (95 %CI) were 8.3 (6.4-10.3) vs. 8.6 (7.0-10.2) at day 43 (p = 0.7357) and 9.7 (6.0-13.4) vs. 10.8 (8.8-12.8) at day 60 (p = 0.8644), respectively. FRNT50 confirmed MNT50 results: SARS-CoV-2 wild-type neutralising antibody GMTs (95 %CI) were 8.4 (6.3-10.5) vs. 9.0 (7.2-10.8) at day 43 (p = 0.5393) and 11.0 (7.0-14.9) vs. 12.3 (10.3-14.5) at day 60 (p = 0.8578). Neutralising antibody seroconversion rates (95 %CI) were 86.7 % (59.5-98.3) vs 94.1 % (71.3-99.8) at day 43 (p = 0.8727) and 92.8 % (66.1-99.8) vs. 100 % (79.4-100.0) at day 60 (p = 0.8873), in ERUCoV-VAC 3 µg and 6 µg groups, respectively. In phase 2 trial, 268 AEs, (67.2 % moderate in severity) occured in 153 (61.2 %) participants. The most common local and systemic AEs were pain at injection site (23 events in 21 [8.4 %] subjects) and headache (56 events in 47 [18.8 %] subjects), respectively. Pain at injection site was the only AE with a significantly higher frequency in the ERUCoV-VAC groups than in the placebo arm in the phase 2 study (p = 0.0322). ERUCoV-VAC groups were comparable in frequency of AEs (p = 0.4587). ERUCoV-VAC 3 µg and 6 µg groups were comparable neutralising antibody (MNT50): GMTs (95 %CI) were 30.0 (37.9-22.0) vs. 34.9 (47.6-22.1) at day 43 (p = 0.0666) and 34.2 (23.8-44.5) and 39.6 (22.7-58.0) at day 60, (p = 0.2166), respectively. FRNT50 confirmed MNT50 results: SARS-CoV-2 wildtype neutralising antibody GMTs were 28.9 (20.0-37.7) and 30.1 (18.5-41.6) at day 43 (p = 0.3366) and 34.2 (23.8-44.5) and 39.6 (22.7-58.0) at day 60 (p = 0.8777). Neutralising antibody seroconversion rates (95 %CI) were 95.7 % (91.4-99.8) vs. 98.9 % (96.9-100.0) at day 43 (p = 0.8710) and 96.6 % (92.8-100.0) vs 98.9 % (96.7-100.0) at day 60 (p = 0.9129) in ERUCoV-VAC 3 µg and 6 µg groups, respectively. CONCLUSIONS: Two-dose regimens of ERUCoV-VAC 3 µg and 6 µg 28 days both had an acceptable safety and tolerability profile and elicited comparable neutralising antibody responses and seroconversion rates exceeding 95 % at day 43 and 60 after the first vaccination. Data availability Data will be made available on request.

Pulmonary artery diameter and NT-proBNP in patients with Covid-19: Predicting prognosis and mortality.

Background: The diverse and complex presentations of COVID-19 continue to impact the world. Factors related to prognosis and mortality are still not fully illuminated. Objectives: We aimed to asses the relationship of N-terminal pro B-type natriuretic peptide (NT-proBNP) and main pulmonary artery diameter (MPAD) with COVID-19 prognosis and mortality. Methods: 152 COVID-19 patients over the age of 18, were included in the study. Thoracic CT, NT-proBNP values, laboratory and demographic data of these patients were obtained by retrospectively examining the patient files and scanning the results through the patient registry. Results: According to multivariate logistic regression (LR) analysis, high NT-proBNP level (OR=3.542; 95% CI=1.745-9.463; p=0.021) and MPAD/ascending aortic diameter (AAD) ratio>0.75 (OR=2.692; 95% CI=1.264-9.312; p=0.036) were determined as independent risk factors predicting mortality in COVID-19 patients. A significant positive correlation was observed between NT-proBNP level and MPA diameter (r=0.296, p<0.001). The cut-off value was measured as 27.5 mm for MPA diameter and 742 pg/ml for NT-proBNP. Conclusions: Accurate and effective interpretation of available radiological and laboratory data is essential to reveal the factors predicting prognosis and mortality in COVID-19. In this study,we evaluated that the thorax CTs and determined that the MPAD/AAD and NT-proBNP level were independent risk factors in predicting mortality.

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.

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.