Comparing Therapeutic versus Prophylactic Enoxaparin Therapy in Severe COVID-19 Patients: A Randomized Clinical Trial.

Background: Coronavirus disease 2019 (COVID-19) has been associated with a hypercoagulopathy state; however, the efficacy of different anticoagulant regimens in preventing thrombotic events is not clear. We aimed to compare therapeutic versus prophylactic enoxaparin therapy in severe COVID-19 patients. Methods: In this single-center, open-label, randomized controlled trial, adult patients with severe COVID-19 presentations and an increased D-dimer level of more than 4 times the normal upper limit were randomly assigned to receive either prophylactic or therapeutic dose of enoxaparin. All patients were observed for at least 4 months regarding the overall survival as the primary outcome. Hospitalization duration, the need for intensive care unit (ICU) admission, the need for mechanical ventilation, and major adverse events (MAEs) were also analyzed as the secondary outcomes. Survival analysis was done via Kaplan-Meier curves and the Log-rank test. Cox regression was used, adjusting for baseline variables. Results: Overall, 237 patients (152 men and 85 women) were randomized to either arm (121 to prophylactic and 116 to therapeutic groups). The mortality rate was 27 (22.3%) and 52 (44.8%) in prophylactic and therapeutic arms, respectively. Prophylactic enoxaparin was associated with better survival in the log-rank test (P < 0.001; HR, 0.42). Additionally, a significantly lower rate of ICU admission, a lower rate of MAEs, and shorter hospitalization were observed in the prophylactic arm (P < 0.001, P = 0.009, and P = 0.028, respectively). Conclusion: The results of the current study were in favor of anticoagulant treatment with prophylactic doses of enoxaparin. Still, due to the limitations of this paper, we suggest that these findings be treated cautiously.

Prognostic significance of CHADS2 and CHA2DS2-VASc scores to predict unfavorable outcomes in hospitalized patients with COVID-19.

Introduction: Owing to the imposed burden of the coronavirus disease 2019 (COVID-19),the need for stratifying the prognosis of patients has never been timelier. Hence, we aimed to ascertain the value of CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M (one point for male instead of female) scores to predict unfavorable outcomes in COVID-19 patients. Methods: We enrolled consecutive patients above 18 years of age with confirmed COVID-19,who were admitted between February 16 and November 1, 2020. The primary endpoint of this study was three-month all-cause mortality. The secondary endpoints were considered four major in-hospital clinical features, including acute respiratory distress syndrome, cardiac injury,acute kidney injury, and mechanical ventilation. Results: A total of 1,406 hospitalized COVID-19 patients were studied, among which 301(21.40%) patients died during the follow-up period. Regarding the risk scores, CHADS 2≥1,CHA2DS2-VASc≥2, and CHA2DS2-VASc-M≥2 were significantly associated with mortality. The performance of all risk scores for predicting mortality was satisfactory (area under the curve:0.668, 0.668, and 0.681, respectively). Appraising secondary endpoints, we found that all three risk scores were associated with increased risk of acute respiratory distress syndrome, cardiac injury, acute kidney injury, and mechanical ventilation. Lastly, we revealed that all risk scores were significantly correlated with serum levels of laboratory biomarkers. Conclusion: Our analysis illustrated that the CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-Mscores could aid prognostication of unfavorable outcomes in COVID-19 patients. Therefore,these easily calculable methods could be integrated into the overall therapeutic strategy to guide the COVID-19 management more accurately.

Association of clinical characteristics, antidiabetic and cardiovascular agents with diabetes mellitus and COVID-19: a 7-month follow-up cohort study.

BACKGROUND: The prognostic factors of long-term outcomes in hospitalized patients with diabetes mellitus and COVID-19 are lacking. METHODS: In this retrospective cohort study, we evaluated patients aged ≥ 18-years-old with the COVID-19 diagnosis who were hospitalized between Feb 20 and Oct 29, 2020, in the Sina Hospital, Tehran, Iran. 1323 patients with COVID-19 entered in the final analysis, of whom 393 (29.7%) patients had diabetes. We followed up patients for incurring in-hospital death, severe COVID-19, in-hospital complications, and 7-month all-cause mortality. By doing univariate analysis, variables with unadjusted P-value < 0.1 in univariate analyses were regarded as the confounders to include in the logistic regression models. We made adjustments for possible clinical (model 1) and both clinical and laboratory (model 2) confounders. RESULTS: After multivariable regression, it was revealed that preadmission use of sulfonylureas was associated with a borderline increased risk of severity in both models [model 1, OR (95% CI):1.83 (0.91-3.71), P-value: 0.092; model 2, 2.05 (0.87-4.79), P-value: 0.099] and major adverse events (MAE: each of the severe COVID-19, multi-organ damage, or in-hospital mortality) in model 1 [OR (95% CI): 1.86 (0.90-3.87), P-value: 0.094]. Preadmission use of ACEIs/ARBs was associated with borderline increased risk of MAE in the only model 1 [OR (95% CI):1.83 (0.96-3.48), P-value: 0.066]. CONCLUSIONS: Preadmission use of sulfonylureas and ACEIs/ARBs were associated with borderline increased risk of in-hospital adverse outcomes. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40200-021-00901-4.

Predicting Risk Score for Mechanical Ventilation in Hospitalized Adult Patients Suffering from COVID-19.

BACKGROUND: COVID-19 has become a pandemic since December 2019, causing millions of deaths worldwide. It has a wide spectrum of severity, ranging from mild infection to severe illness requiring mechanical ventilation. In the middle of a pandemic, when medical resources (including mechanical ventilators) are scarce, there should be a scoring system to provide the clinicians with the information needed for clinical decision-making and resource allocation. OBJECTIVES: This study aimed to develop a scoring system based on the data obtained on admission, to predict the need for mechanical ventilation in COVID-19 patients. METHODS: This study included COVID-19 patients admitted to Sina Hospital, Tehran University of Medical Sciences from February 20 to May 29, 2020. Patients' data on admission were retrospectively recruited from Sina Hospital COVID-19 Registry (SHCo-19R). Multivariable logistic regression and receiver operating characteristic (ROC) curve analysis were performed to identify the predictive factors for mechanical ventilation. RESULTS: A total of 681 patients were included in the study; 74 patients (10.9%) needed mechanical ventilation during hospitalization, while 607 (89.1%) did not. Multivariate logistic analysis revealed that age (OR,1.049; 95% CI:1.008-1.091), history of diabetes mellitus (OR,3.216; 95% CI:1.134-9.120), respiratory rate (OR,1.051; 95% CI:1.005-1.100), oxygen saturation (OR,0.928; 95% CI:0.872-0.989), CRP (OR,1.013; 95% CI:1.001-1.024) and bicarbonate level (OR,0.886; 95% CI:0.790-0.995) were risk factors for mechanical ventilation during hospitalization. CONCLUSIONS: A risk score has been developed based on the available data within the first hours of hospital admission to predict the need for mechanical ventilation. This risk score should be further validated to determine its applicability in other populations.

Clinical significance of prognostic nutrition index in hospitalized patients with COVID-19: Results from single-center experience with systematic review and meta-analysis.

BACKGROUND: We aimed to ascertain risk indicators of in-hospital mortality and severity as well as to provide a comprehensive systematic review and meta-analysis to investigate the prognostic significance of the prognostic nutrition index (PNI) as a predictor of adverse outcomes in hospitalized coronavirus disease 2019 (COVID-19) patients. METHODS: In this cross-sectional study, we studied patients with COVID-19 who were referred to our hospital from February 16 to November 1, 2020. Patients with either a real-time reverse-transcriptase polymerase chain reaction test that was positive for COVID-19 or high clinical suspicion based on the World Health Organization (WHO) interim guidance were enrolled. A parallel systematic review/meta-analysis (in PubMed, Embase, and Web of Science) was performed. RESULTS: A total of 504 hospitalized COVID-19 patients were included in this study, among which 101 (20.04%) patients died during hospitalization, and 372 (73.81%) patients were categorized as severe cases. At a multivariable level, lower PNI, higher lactate dehydrogenase (LDH), and higher D-dimer levels were independent risk indicators of in-hospital mortality. Additionally, patients with a history of diabetes, lower PNI, and higher LDH levels had a higher tendency to develop severe disease. The meta-analysis indicated the PNI as an independent predictor of in-hospital mortality (odds ratio [OR] = 0.80; P < .001) and disease severity (OR = 0.78; P = .009). CONCLUSION: Our results emphasized the predictive value of the PNI in the prognosis of patients with COVID-19, necessitating the implementation of a risk stratification index based on PNI values in hospitalized patients with COVID-19.

Clinical Characteristics of COVID-19 Patients with Gastrointestinal Symptoms.

BACKGROUND: We aimed to assess the gastrointestinal (GI) manifestations of patients with severe acute respiratory syndrome coronavirus 2 infection and determine factors predicting disease prognosis and severity among patients with GI symptoms. METHODS: In this retrospective study, we evaluated laboratory confirmed (by real-time polymerase chain reaction) inpatient cases of coronavirus-associated disease 2019 (COVID-19), referred to Sina hospital, a tertiary educational hospital of Tehran University of Medical Sciences, from March 10 to May 20, 2020. Demographic and clinical characteristics, laboratory data, outcomes and treatment data were extracted and analyzed using SPSS version 20. RESULTS: A total of 611 patients (234 women and 377 men) were included with 155 patients having GI symptoms. The most prevalent reported GI symptom was nausea/vomiting in 115 (18.8%) of patients. A total of 20 patients (3.2%) only had GI symptoms (without respiratory symptoms). There was no statistically significant difference in the clinical outcomes, disease severity, intensive care unit (ICU) admission and mortality between patients with and without GI symptoms. Aspartate Aminotransferase level was associated with 446% increased risk of disease severity (adjusted odds ratio: 5.46, 95% CI: 2.01 to 14.81) (P=0.040) among patients with GI symptoms. Additionally, we found that treatment with antibiotics in addition to mechanical ventilation was associated with increased survival among patients with GI symptoms (Pearson Chi square: 6.22; P value: 0.013). CONCLUSION: More attention should be paid to patients with only GI symptoms for early patient detection and isolation. Moreover, patients with GI manifestations are not exposed to higher rates of disease severity or mortality.

Risk indicators associated with in-hospital mortality and severity in patients with diabetes mellitus and confirmed or clinically suspected COVID-19.

PURPOSE: This study aims to investigate risk indicators of in-hospital mortality and severity of coronavirus disease-2019 (COVID-19) in patients with diabetes mellitus (DM). METHODS: In this retrospective study, we studied patients with COVID-19 referred to Sina Hospital, Tehran, Iran, from February 20 to May 14, 2020. Patients with either a positive real-time reverse-transcriptase polymerase-chain-reaction test of swab specimens or high clinical suspicion according to the World Health Organization interim guidance were included. We accurately divided all patients into two groups based on diabetes affection and followed-up patients with DM based on incurring death, severe COVID-19, and in-hospital complications. RESULTS: We enrolled 574 patients with COVID-19 in the final analysis, of whom 176 (30.7%) patients had DM. In this study, 104 (18.1%) patients deceased, and 380 (66.2%) patients incurred severe COVID-19. We found that COVID-19 patients with DM had a significantly higher mortality rate (P value<0.001), severe disease (P value<0.001), and in-hospital complications (all P values<0.05). Besides that, in patients with DM, admission temperature (odds ratio (OR): 1.69, P value: 0.024), oxygen saturation (OR: 0.92, P value: 0.004), and urea (OR: 1.01, P value: 0.048) were independent risk indicators of in-hospital mortality. In addition, subgroup analysis of diabetic patients based on admission glucose level showed significant differences between these groups regarding acute cardiac injury (P value: 0.044) and acute liver injury (P value: 0.002). CONCLUSIONS: Patients with DM admitted with lower oxygen saturation, elevated temperature, and higher urea are more susceptible to progress to more severe COVID-19 and poor prognosis. This indicates a necessity for more precise care during hospitalization for these patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40200-020-00701-2.

Vitamin D sufficiency, a serum 25-hydroxyvitamin D at least 30 ng/mL reduced risk for adverse clinical outcomes in patients with COVID-19 infection.

BACKGROUND: To investigate the association between serum 25-hydroxyvitamin D levels and its effect on adverse clinical outcomes, and parameters of immune function and mortality due to a SARS-CoV-2 infection. STUDY DESIGN: The hospital data of 235 patients infected with COVID-19 were analyzed. RESULTS: Based on CDC criteria, among our study patients, 74% had severe COVID-19 infection and 32.8% were vitamin D sufficient. After adjusting for confounding factors, there was a significant association between vitamin D sufficiency and reduction in clinical severity, inpatient mortality serum levels of C-reactive protein (CRP) and an increase in lymphocyte percentage. Only 9.7% of patients older than 40 years who were vitamin D sufficient succumbed to the infection compared to 20% who had a circulating level of 25(OH)D< 30 ng/ml. The significant reduction in serum CRP, an inflammatory marker, along with increased lymphocytes percentage suggest that vitamin D sufficiency also may help modulate the immune response possibly by reducing risk for cytokine storm in response to this viral infection. CONCLUSION: Therefore, it is recommended that improving vitamin D status in the general population and in particular hospitalized patients has a potential benefit in reducing the severity of morbidities and mortality associated with acquiring COVID-19.

Association of Serum Level of 25-Hydroxy Vitamin D Deficiency and Pulmonary Function in Healthy Individuals.

BACKGROUND: Besides the extensive regulatory role in growing number of biologic processes, vitamin D has been recently considered essential for lungs function as well as protective against exacerbation of chronic obstructive pulmonary diseases. We assessed the correlation between vitamin D serum levels with pulmonary function in healthy individuals. METHODS: In a cross-sectional study, healthy volunteer (n = 92) participants underwent the following laboratory procedures: a blood test, a 24-hour urine collection test, and the serum level of 25-hydroxy vitamin D before undergoing spirometry. Linear correlation coefficient was calculated to detect the association between serum level of 25-hydroxy vitamin D and pulmonary volumes. RESULTS: The mean age of participants was 39.95 ± 9.98 years. 48% of participants showed different levels of 25-hydroxy vitamin D deficiency. We recognized a consistent direct positive correlation between serum levels of 25-hydroxy vitamin D and lung function volumes. The coefficient for forced vital capacity, forced expiratory volume in 1 second, forced expiratory flow 25-75%, and forced expiratory volume in 1 second/forced vital capacity ratio were 0.610, 0.509, 0.454, and 0.551, respectively. CONCLUSIONS: Our findings suggest correlation between higher serum levels of 25-hydroxy vitamin D and improved pulmonary function. Accordingly, supplemental vitamin D might significantly improve treatment response.

Thoracic Kidney: Extremely Rare State of Aberrant Kidney.

The thorax is the rarest place among all forms of renal ectopia. We report a rare case of an unacquired thoracic kidney. Only about 200 cases of the thoracic kidney have ever been reported in medical literature worldwide. In this paper we present the rarest form of nontraumatic nonhernia associated, truly ectopic thoracic kidney. The differential diagnosis and management options and classification of this rare form of aberrant kidney are discussed.

Prevalence of tuberculosis in patients with anthracosis: study on 150 subjects.

BACKGROUND: A probable concordance and association between pulmonary tuberculosis and anthracosis was observed in the published literature. We conducted this study to evaluate the clinical and radiologic characteristics of patients with bronchoscopic evidence of anthracosis as well as the prevalence of pulmonary tuberculosis in patients with anthracosis. METHODS: Included in the study were 150 consecutive patients with evidence of anthracosis as evidenced by bronchoscopy. Pulmonary tuberculosis diagnostic work up which included bronchoalveolar lavage, sputum smears and cultures, or histologic examination of lung biopsies was performed on all patients. Patients' clinical, pathological, and radiological findings were also recorded and analyzed. RESULTS: A total of 88 men and 62 women, ranging in age from 42 to 92 years were included in the study. Dyspnea (38.7%) and productive cough (35.3%) were among the most common chief complaints. The abnormal bronchoscopic findings were seen most frequently in the right middle lobe bronchus. In 42 patients pulmonary tuberculosis was confirmed either bacteriologically (n = 32) or histologically (n = 10). CT scans of 26 patients were examined, of which the most frequent findings were consolidation and a reticular pattern. Pleural involvement was observed in 14 patients. CONCLUSION: Prevalence of pulmonary tuberculosis was higher among those with bronchial stenosis (P < 0.05). These findings have suggested that bronchial anthracosis, especially cases of localized anthracosis, in patients with bronchial stenosis and in those without a history of smoking or occupational exposure may be caused by tuberculosis.

Relation between pulmonary function and inflammatory biomarkers in hemodialysis patients.

The purpose of our study was to investigate the relationship between pulmonary function and serum levels of C-reactive protein (CRP), ferritin, albumin, and erythrocyte sedimentation rate, as inflammatory biomarkers, in hemodialysis patients. Ninety-eight patients, who were dialyzed at least for 3 months, were included in this study. Patients' blood samples were collected and pulmonary function tests, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF) were measured and expressed as the %predicted using appropriate normal values for the patients' sex, age, and height (%FVC, %FEV1, and %PEF), at the same time. The patients with CRP ≥ 10 µg/mL were significantly older and had lower values of %FEV1, %FVC and %PEF (p = 0.006, p = 0.001, and p = 0.016, respectively); whereas just %FEV1 (p = 0.025) and %FVC (p = 0.009) had significant differences between the patients with ferritin ≥ 100 µg/L and other patients. However, no other significant differences were found between inflammatory biomarkers and the pulmonary function tests. We concluded that inflammation has a close relation with pulmonary dysfunction in hemodialysis patients.