Evidence map›Paper›PMID 37951972›Full record

Trial reportTrials2023

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 and 7 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Maryam HafiziDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Somayeh KalanakyDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Saideh FakharzadehDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Pegah KarimiDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Atefeh FakharianClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Somayeh LookzadehClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Esmaeil MortazClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Maryam Sadat MirenayatChronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Jalal HeshmatniaClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mehrdad Bakhshayesh KaramClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Homa ZamaniClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Alireza NadjiClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mihan Pourabdollah ToutkaboniClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Saeed Oraee-YazdaniFunctional Neurosurgery Research Center, Comprehensive Neurosurgical Center of Excellence, Shohada Tajrish, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad Esmaeil AkbariCancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. crc@sbmu.ac.ir.
Hamidreza JamaatiClinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. hamidjamaati@hotmail.com.
Mohammad Hassan NazaranDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran. mnazaran@nanochelatingtechnology.com.ORCID http://orcid.org/0000-0002-9413-2295
Masih Daneshvari Hospital · IRShahid Beheshti University of Medical Sciences · IRIran Khodro (Iran) · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsLaboratory-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.

resultsThe 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.

conclusionsIn 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 registrationIranian Registry of Clinical Trials RCT20170731035423N2 . Registered on June 12, 2020.

Indexed as

COVID-19SeleniumAdultCytokinesDouble-Blind MethodHumansInterleukin-6IranIronSARS-CoV-2Treatment OutcomeTumor Necrosis Factor-alphaCytokinesInterleukin-6IronSeleniumTumor Necrosis Factor-alphaBCc1COVID-19Cytokine storm syndromeHep-SIL-6Nanochelating technology

Identifiers

PMID37951972
PMCPMC10638761
OpenAlexW4388586989

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.