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
Maryam Hafizi,
Somayeh Kalanaky,
Saideh Fakharzadeh,
Pegah Karimi,
Atefeh Fakharian,
Somayeh Lookzadeh,
Esmaeil Mortaz,
Maryam Sadat Mirenayat,
Jalal Heshmatnia,
Mehrdad Bakhshayesh Karam,
Homa Zamani,
Alireza Nadji,
Mihan Pourabdollah Toutkaboni,
Saeed Oraee-Yazdani,
Mohammad Esmaeil Akbari,
Hamidreza Jamaati,
Mohammad Hassan Nazaran
Affiliations
Maryam Hafizi
Department of Research and Development, Sodour Ahrar Shargh Company
Somayeh Kalanaky
Department of Research and Development, Sodour Ahrar Shargh Company
Saideh Fakharzadeh
Department of Research and Development, Sodour Ahrar Shargh Company
Pegah Karimi
Department of Research and Development, Sodour Ahrar Shargh Company
Atefeh Fakharian
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Somayeh Lookzadeh
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Esmaeil Mortaz
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Maryam Sadat Mirenayat
Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Jalal Heshmatnia
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Mehrdad Bakhshayesh Karam
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Homa Zamani
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Alireza Nadji
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Mihan Pourabdollah Toutkaboni
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Saeed Oraee-Yazdani
Functional Neurosurgery Research Center, Comprehensive Neurosurgical Center of Excellence, Shohada Tajrish, Shahid Beheshti University of Medical Sciences
Mohammad Esmaeil Akbari
Cancer Research Center, Shahid Beheshti University of Medical Sciences
Hamidreza Jamaati
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences
Mohammad Hassan Nazaran
Department of Research and Development, Sodour Ahrar Shargh Company
Abstract 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). 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.
