Kyiv City Clinical Hospital №4
Bogomolets National Medical University
Solyaryk S. O.Head doctorKyiv City Clinical Hospital №4
Bogomolets National Medical University
Oliynyk O. V.
professorKyiv City Clinical Hospital №4
Frank M.лаборант- Bogomolets National Medical University
Oliynyk Y. V.
doctor
Nowadays, treatment of COVID-19 is currently a major unresolved issue. The aim of this study was to investigate the therapeutic properties of the medication Virlaza/Immune COV in patients with moderate symptoms of COVID-19. The study was randomized and controlled. 58 moderate patients with COVID-19 who required oxygen support and had no comorbidities were studied.
Patients were divided into two groups: those who received the medication and standard treatment (n = 30), and those who received only standard treatment (n = 28). Patients with Virlaza/Immune COV on day 14 had significantly higher values of SpO2 (95.3 ± 2.27) compared with the second group (93.38 ± 2.14; p <0.05), significantly lower values ferritin (130.9 ± 6.23 and 196.55 ± 12.81, respectively; p <0.05), significantly lower values of C-reactive protein (7.7 ± 0.72 and 24.05 ± 3.22; p<0.05) .
It is concluded that Virlaza/Immune COV can be successfully used to treat patientswith moderate COVID-19.
Introduction
Despite the efforts of medical science world, the treatment of COVID-19 is a significant problem. The proposed products forthe treatment of this pathology are often not effective enough. Therefore, the study of the therapeutic efficacy of medication can be used to treat COVID-19 and is quite relevant. Many Protocols for the COVID-19 treatment recommend the use of natural origin pills, Zinc and vitamin D, in addition to synthetic drugs [1].
The Israeli medical company LIBI PHARM recommends for the treatment of patientswith COVID-19 to use a drug of plant origin Virlaza/Immune COV [2]. This drug is acombination of natural complex components and plant extracts that grow in Israel. The drug also contains natural minerals extracted from the Dead Sea. The drug is used to treat acuterespiratory viral infections, conditions accompanied by pulmonary fibrosis, post-covid syndrome. According to the Institute of Pulmonology in São Paulo, where the properties of the drug were studied, this product has the properties to increase saturation and normalize body temperature [2].
The aim of this study was to investigate the therapeutic properties of the Virlaza/ImmuneCOV medication in patients with moderate COVID-19.
Methods and materials
A randomized controlled testing of Virlaza/Immune COV was performed in the infectious department of Kyiv City Clinical Hospital №4. In total, a clinical testing was studied in patients with moderate COVID-19 (n = 38) who required oxygen support and had no comorbidities.
Patients were divided into two groups: those who received the medication and standard treatment (n = 30) and those who received only standard treatment (n = 28). The severity of the condition was assessed before the start of the testing and on the fourteenth day by the following indicators: number of leukocytes, erythrocytes, rod-shaped neutrophils, eosinophils, platelets, procalcitonin, ferritin, C-reactive protein, D- dimer, IL-IL, IL-6.
Ferritin levels were determined by quantitative immunoturbidimetric method [3], IL-6 by electrochemiluminescent immunoassay[4], C-reactive protein by solid-phase immunometric analysis of sandwich type [4], D-dimer by microlatex agglutination reaction with photometer - immunochemical method with electrochemiluminescent detection [7]. The partial pressure of oxygen was determined using a gas analyzer BGA 101 from Wondfo, China.
The diagnosis was confirmed by PCR. Patients without impaired consciousness who required oxygen support (humidified oxygen insufflation 6-15 l / min, initial SpO2 <86-91% at FiO2 0.21; SpO2> 94% at humidified oxygen insufflation) were selected for inclusion in the study.
The Criteria for inclusion in the study are following:
- laboratory confirmation of Covid-19;
- reduction of partial pressure of oxygen in blood at breath of atmospheric air below 65 mm of m.v.;
- availability of informed patient consent to participate in the study;
The Criteria for excluding patients from the study are following:
- hypersensitivity to Virlaza/Immune COV;
- patient participation in other clinical testing.
All patients who met the inclusion criteria and did not have exclusion criteria were randomized to one of two groups. Patients in the two groups did not differ statistically (p <0.1) in age, body mass index, SpO2 and estimated laboratory parameters.
Each patient in the first group received 30 drops of the medication three times a day (9.00, 14.00, 19.00), notlater than 1 hour before meals.
Results and discussion
In both groups, during the treatment, there was a general improvement in the condition and well-being of patients. None of thepatients required mechanical ventilation. Among the complications were cases of bacterial infections of the respiratory tract, three cases in each group.
In patients of the first group on the 14th day (Table 1) there were
- significantly higher values of SpO2 (95.3 ± 2.27) compared with the second group(93.38 ± 2.14; p <0.05),
- significantly lower values of ferritin (130.9 ± 6.23 and 196.55 ± 12.81, respectively; p <0.05),
- significantly lower values of C-reactive protein (7.70 ± 0.72 and 24.05 ± 3, 22; p <0.05).
Other measured indicators did not differ statistically (p> 0.05).
The obtained data can be explained as follows. As it was found during a study of the effectiveness of the medication at the Institute of Pulmonology in São Paulo [2], Virlaza/Immune COV significantly inhibits the activation of bronchial epithelial cells(BEAS-2B), which occurs in vivo in COVID-19 disease, because Virlaza/Immune COVinhibits the synthesis and release of IL-1b (p <0,001), IL-6 <0.05), TNF-α (p
<0.001).
The medication reduces the activation of lung fibroblasts (MRC-5 cells) by reducing the synthesis and release of IL-1b (p <0,001), IL-6 (p <0,05), TNF-a (p<0,001), which are classic cytokines and are used as biomarkers of fibroblast activation [2].In addition, Virlaza/Immune COV can induce the synthesis and release of the anti-inflammatory cytokine IL-1RA, which is a trigger anti-inflammatory cytokine that involvesthe inactivation of lung fibroblasts induced by COVID-19.
In addition, the therapeutic properties of Virlaza/Immune COV can be explained by itsantioxidant properties. Virlaza/Immune COV contains selenomethionine, selenocysteineand sodium selenite, which are antioxidants.
The effect of this medication is manifested in the protection of cell membranes andcell organelles, which are destroyed during the development of COVID-19 [8, 9].
Conclusion
- 1The use of the mediation Virlaza/Immune COV in patients with moderate COVID- 19 leads to a significant increase in SrO2 (p <0.05), a decrease in serum ferritin (p <0.05) and C-reactive protein (p <0 , 05).
- 2Virlaza/Immune COV can be successfully used to treat moderate COVID-19.
1. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines Get the latest public health information from CDC: https://www.coronavirus.gov
2. Інструкція до препарату Virlaza/ImmuneCOV™ . LIBI PHARM. Київ. 2021.
3. Ruscitti P., Giacomelli R. Ferritin and Severe COVID-19, from Clinical Observations to Pathogenic Implications and Therapeutic Perspectives. Isr Med Assoc J. 2020 Aug;8(22):450-452. PMID: 32812721.
4. McGonagle D, Sharif K, O'Regan A, Bridgewood C. The Role of Cytokines including Interleukin-6 in COVID-19 induced Pneumonia and MacrophageActivation Syndrome-Like Disease. Autoimmun Rev. 2020;19(6):102537. doi: 10.1016/j.autrev.2020.102537.
5. Williams DK, Muddiman J. Absolute Quantification of C-Reactive Protein in Human Plasma Derived from Patients with Epithelial Ovarian Cancer Utilizing Protein Cleavage Isotope Dilution Mass Spectrometry J Proteome Res. 2009; 8(2): 1085–1090. doi: 10.1021/pr800922p.
6. Gosselin RC, Owings JT, Utter GH. A new method for measuring D-dimer usingimmunoturbidometry: a study of 255 patients with suspected pulmonary embolism and deep vein thrombosis. Blood Coagul Fibrinolysis. 2000;11(8):715-21. doi: 10.1097/00001721-200012000-00004.
7. Song J, Park DW, Moon S. Diagnostic and prognostic value of interleukin-6, pentraxin3, and procalcitonin levels among sepsis and septic shock patients: a prospective controlled study according to the Sepsis-3 definitions. BMC Infectious Diseases. 2019; 19, Article number: 968;https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-019-4618- 7.
8. Kieliszek M, Lipinski B. Selenium supplementation in the prevention ofcoronavirus infections (COVID-19). Med Hypotheses, 2020.
9. Zhang J, Taylor EW, Bennett K. Association between regional selenium status and reported outcome of COVID-19 cases in China. Am J ClinNutr., 2020.
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