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
Trials, doi:10.1186/s13063-023-07624-2
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, doubleblind, 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.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s13063-023-07624-2.
Additional file 1: Table S A) Descriptive Statistics of cell blood count by Group (nanomedicines vs. Placebo). B) Tests of Within-Subjects Effects. The blood samples were taken and analyzed on day zero, at discharge, and at the end of the treatment (on day 28). The results indicated that all the measured parameters were at normal range on day 28, and there was no significant difference between the treatment and placebo groups.
Authors' contributions MH and SF performed most of the experiments and data acquisition and also wrote the manuscript. SK carried out the synthesis of the BCc1 and Hep-S nanomedicine. AF, SL, SM, MM, JH, MB, HZ, AN, MP, PK, and SY collected the data and selected the patients. MHN contributed to the conception and design of the BCc1 and Hep-S nanomedicine. MEA and HJ designed the study. All authors read and approved the final manuscript.
Declarations Ethics approval and consent to participate
Consent for publication Not applicable.
Competing interests Mohammad Hassan Nazaran is the owner of Nanochelating Technology. The authors declare that they have no competing interests. • fast, convenient online submission • thorough peer review by experienced researchers in your field
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