Beneficial effects of the combination of BCc1 and Hep-S nanochelating-based medicines on IL-6 in hospitalized moderate COVID-19 adult patients: a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: In the severe forms of COVID-19 and many other infectious diseases, the patients develop a cytokine storm syndrome (CSS) where pro-inflammatory cytokines such as IL-6 and TNF-α play a key role in the development of this serious process. Selenium and iron are two important trace minerals, and their metabolism is tightly connected to immune system function. Numerous studies highlight the role of selenium and iron metabolism changes in the procedure of COVID-19 inflammation. The immunomodulator effect of nanomedicines that are synthesized based on nanochelating technology has been proved in previous studies. In the present study, the effects of the combination of BCc1(with iron-chelating property) and Hep-S (containing selenium) nanomedicines on mentioned cytokines levels in hospitalized moderate COVID-19 patients were evaluated. METHODS: Laboratory-confirmed moderate COVID-19 patients were enrolled to participate in a randomized, double-blind, placebo-controlled study in two separate groups: combination of BCc1 and Hep-S (N = 62) (treatment) or placebo (N = 60) (placebo). The blood samples were taken before medications on day zero, at discharge, and 28 days after consumption to measure hematological and biochemical parameters and cytokine levels. The clinical symptoms of all the patients were recorded according to an assessment questionnaire before the start of the treatment and on days 3 and discharge day. RESULTS: The results revealed that consumption of the nanomedicines led to a significant decrease in the mean level of IL-6 cytokine, and at the end of the study, there was a 77% downward trend in IL-6 in the nanomedicine group, while an 18% increase in the placebo group (p < 0.05). In addition, the patients in the nanomedicines group had lower TNF-α levels; accordingly, there was a 21% decrease in TNF-α level in the treatment group, while a 31% increase in this cytokine level in the placebo was observed (p > 0.05). On the other hand, in nanomedicines treated groups, clinical scores of coughing, fatigue, and need for oxygen therapy improved. CONCLUSIONS: In conclusion, the combination of BCc1 and Hep-S inhibits IL-6 as a highly important and well-known cytokine in COVID-19 pathophysiology and presents a promising view for immunomodulation that can manage CSS. TRIAL REGISTRATION: Iranian Registry of Clinical Trials RCT20170731035423N2 . Registered on June 12, 2020.

Identification of Sonographic Features for Predicting Benign Versus Malignant Mediastinal or Hilar Lymph Nodes Using Endobronchial Ultrasound.

OBJECTIVES: In countries with a high prevalence of tuberculosis, such as Iran, the differentiation of malignant from non-malignant tumors is crucial. We attempted to find a reliable model in determining malignant nodes by investigating the sonographic characteristics of lymph nodes (LNs). METHODS: In this prospective study, the morphologic characteristics of LNs, including size, shape, vascular pattern, echogenicity, margin, coagulation necrosis sign, calcification, and central hilar structure, which had been obtained during endobronchial ultrasound-guided transbronchial needle aspiration, were compared with the final pathology results. RESULTS: We examined 253 LNs from 93 patients. Round shape, non-hilar vascular pattern, heterogeneous echogenicity, hyperechogenicity, distinct margin, and the existence of necrosis signs were significantly higher in malignant nodes. On the other hand, the existence of calcification, as well as the presence of central hilar structure, were highly suggestive of benign nodes (p < 0.050). Multivariate logistic regression revealed that size > 1 cm, heterogeneous echogenicity, hyperechogenicity, the existence of necrosis signs, and the lack of central hilar structure are independent predictive factors for malignancy. The accuracy of each of the aforementioned characteristics are 42.3%, 71.5%, 71.9%, 73.5%, and 65.6%, respectively. Of 74 malignant LNs, 100% had at least one of these independent factors. CONCLUSIONS: The morphological features of LNs based on endobronchial ultrasound-guided transbronchial needle aspiration can play a role in predicting malignancy.