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
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 m...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07624-2 |
| _version_ | 1797629968193159168 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Maryam Hafizi |
| collection | DOAJ |
| description | 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). 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. |
| first_indexed | 2024-03-11T11:01:19Z |
| format | Article |
| id | doaj.art-99951f6850c74caaa844a52adb5e5cea |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T11:01:19Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-99951f6850c74caaa844a52adb5e5cea2023-11-12T12:29:15ZengBMCTrials1745-62152023-11-0124111510.1186/s13063-023-07624-2Beneficial 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 trialMaryam Hafizi0Somayeh Kalanaky1Saideh Fakharzadeh2Pegah Karimi3Atefeh Fakharian4Somayeh Lookzadeh5Esmaeil Mortaz6Maryam Sadat Mirenayat7Jalal Heshmatnia8Mehrdad Bakhshayesh Karam9Homa Zamani10Alireza Nadji11Mihan Pourabdollah Toutkaboni12Saeed Oraee-Yazdani13Mohammad Esmaeil Akbari14Hamidreza Jamaati15Mohammad Hassan Nazaran16Department of Research and Development, Sodour Ahrar Shargh CompanyDepartment of Research and Development, Sodour Ahrar Shargh CompanyDepartment of Research and Development, Sodour Ahrar Shargh CompanyDepartment of Research and Development, Sodour Ahrar Shargh CompanyClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesChronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesFunctional Neurosurgery Research Center, Comprehensive Neurosurgical Center of Excellence, Shohada Tajrish, Shahid Beheshti University of Medical SciencesCancer Research Center, Shahid Beheshti University of Medical SciencesClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical SciencesDepartment of Research and Development, Sodour Ahrar Shargh CompanyAbstract 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.https://doi.org/10.1186/s13063-023-07624-2COVID-19BCc1Hep-SNanochelating technologyIL-6Cytokine storm syndrome |
| spellingShingle | 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 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 Trials COVID-19 BCc1 Hep-S Nanochelating technology IL-6 Cytokine storm syndrome |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | COVID-19 BCc1 Hep-S Nanochelating technology IL-6 Cytokine storm syndrome |
| url | https://doi.org/10.1186/s13063-023-07624-2 |
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