Clinical experience of Raphamin therapy in outpatients after hospital treatment of COVID-19 pneumonia

Abstract

Post-infectious immunosuppression may cause repeated hospitalization after COVID-19 pneumonia. The results of the observational study of the Raphamin use for immunotherapy in the recovery period of COVID-19 pneumonia are presented.

Aim: to estimate efficiency of Rafamin usage in patients who have completed the course of inpatient treatment for coronavirus pneumonia.

Material and methods. Thirty patients aged 18 to 80 years after hospital treatment of COVID-19 pneumonia were included and randomized into 2 groups (1 : 1). All patients received anticoagulants, antioxidants, metabolic drugs. Patients of the 1st group (n=15) were additionally prescribed Raphamin for 5 days. The primary endpoint was the number of repeated hospitalizations due to consequences of COVID-19 and/or new cases of acute respiratory infection for 28 days of follow-up. In addition, dynamic of immune and inflammatory markers (absolute lymphocyte count, C-reactive protein), proportion of patients with immune dysregulation, and duration of symptoms associated with COVID-19 were assessed.

Results. The number of hospitalized patients in group 1 was 0 (vs 5 in group 2, p=0.0421). Study therapy reduced the risk of repeated hospitalizations in 1.44 times [relative risk 1.44; 95% confidence interval 0.91–2.28]; duration of breathlessness decreased from 24.5 to 15.3 days (p=0.0108), and duration of fatigue reduced from 23.6 to 16.8 days (p=0.0452). The proportion of patients with immune markers normalization was 2 times higher than in the comparison group on 14 day of observation.

Conclusion. The immunomodulatory therapy may be recommended during the recovery period of COVID-19 pneumonia.

Keywords:COVID-19; pneumonia; Raphamin; immunomodulatory therapy; hospitalization

Funding. The study has no sponsor support.

Conflict of interest. The authors declare no conflict of interest

Contribution. Research design, obtaining and analysis of the data, writing the text of the manuscript – Mordyk A.V.; writing the text of the manuscript, review of publications on the topic – Puzyreva L.V., Antipova E.P., Verbanov A.V.

For citation: Mordyk A.V., Puzyreva L.V., Antipova E.P., Verbanov A.V. Clinical experience of Raphamin therapy in outpatients after hospital treatment of COVID-19 pneumonia. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2022; 11 (3): 81–7. DOI: https://doi.org/10.33029/2305-3496-2022-11-3-81-87

References

1. Zaitsev A.A., Ternovskaya N.A, Chelan E.A., et al. Ongoing symptomatic COVID-19–pharmacotherapy possibilities. Vestnik Sovremennoi Klinicheskoi Mediciny [Bulletin of Contemporary Clinical Medicine]. 2022; 15 (1): 26–33. DOI: https://doi.org/10.20969/VSKM.2022.15(1).26-33 (in Russian)

2. Belotserkovskaya Yu.G., Romanovskikh A.G., Smirnov I.P., et al. Long COVID-19.Consilium Medicum. 2021; 23 (3): 26168. (in Russian)

3. Drapkina O.M., Drozdova L.Yu., Avdeev S.N., et al. Guidelines were approved at the meeting of the academic council of the National Medical Research Center for Therapy and Preventive Medicine, Moscow (Protocol No. 10 of 19.10.2021). Profilakticheskaya Meditsina [Russian Journal of Preventive Medicine]. 2020; 23 (3): 2004‑41. DOI: https://doi.org/10.17116/profmed2020230324 (in Russian)

4. Lukyanov M.M., Kutishenko N.P., Martsevich S.Yu., et al. Long-term outcomes in patients after COVID-19: data from the TARGET-VIP registry. Russian Journal of Cardiology. 2022; 27 (3): 4912. DOI: https//doi.org/10.15829/1560-4071-2022-4912 (in Russian)

5. Svistunov A.A., Makhnach G.K., Bunina D.V., et al. Administration of the immunomodulatory drug aminodihydrophthalazinedione sodium for prevention of progression pneumonia induced COVID-19. Terapevticheskii arkhiv [Therapeutic Archive]. 2020; 92 (11): 65–70. DOI: https://doi.org/10.26442/00403660.2020.11.000820 (in Russian)

6. Yakubova L., Smirnova L. Post-COVID syndrome variety and possibilities of correction of post-infectious immunosuppression. Recipe. 2021; 24 (5): 614–24. DOI: https://doi.org/10.34883/PI.2021.24.5.001 (in Russian)

7. Petrova N.V., Emelianova A.G., Tarasov S.A., et al. Efficacy of an experimental drug based on technologically processed antibodies in models of influenza infection and secondary bacterial pneumonia: results of a preclinical study. Patogenez. 2020; 18 (4): 55–63. DOI: https://doi.org/10.25557/2310-0435.2020.04.55-63

8. Emelianova A.G., Petrova N.V., Fremez C., et al. Therapeutic potential of highly diluted antibodies in antibiotic-resistant infection. Eur J Pharm Sci. 2022; 173: 106161. DOI: https://doi.org/10.1016/j.ejps.2022.106161

9. Epstein O. The spatial homeostasis hypothesis. Symmetry. 2018; 10 (4): 103. DOI: https://doi.org/10.3390/sym10040103

10. Tarasov S.A., Gorbunov E.A., Don E.S., et al. Insights into the mechanism of action of highly diluted biologics. J Immunol. 2020; 205 (5): 1345–54. DOI: https://doi.org/10.4049/jimmunol.2000098

11. Woods K.N. New insights into the microscopic interactions associated with the physical mechanism of action of highly diluted biologics. Sci Rep. 2021; 11 (1): 13774. DOI: https://doi.org/10.1038/s41598-021-93326-1

12. Mkrtumyan A., Romantsova T., Vorobiev S., et al. Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial. Diabetes Res Clin Pract. 2018; 142: 1–9. DOI: https://doi.org/10.1016/j.diabres.2018.04.044

13. Pushkar D., Vinarov A., Spivak L., et al. Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial. Cent European J Urol. 2018; 71: 427–35. DOI: https://doi.org/10.5173/ceju.2018.1803

14. Geppe N.A., Blokhin B.M., Shamsheva O.V., et al. Efficacy and safety of Ergoferon in children from 6 months to 6 years old with acute respiratory viral infections in contemporary outpatient practice: a multicenter, double-blind, placebo-controlled randomized trial. Can Respir J. 2021; 2021: 5570178. DOI: https://doi.org/10.1155/2021/5570178

15. Khamitov R.F. Physicists explained the principle of operation of innovative drugs based on high dilutions. Medicinskij vestnik [Medical Gazette]. 2022; 1: 13 (in Russian)

16. Milioglou I., Kalaitzidou I., Ladomenou F. Interpretation of lymphocyte subset counts by the general pediatrician. Pediatr Int. 2019; 61 (1): 16–22. DOI: https://doi.org/10.1111/ped.13701

17. Development of the COVID-19 infection model: a preclinical study of a new drug Rafamin. Available at: https://www.vibiosphen.com/development-covid-19-infection-model-preclinical-study-new-drug-rafamin

18. Don E., Petrova N., Stittelaar K. et al. Antiviral efficacy of released-active antibodies to interferon gamma against MERS Coronavirus. In: 30th European Congress of Clinical Microbiology and Infectious Diseases. Paris, 2020: 1996.

19.  Khamitov R.F., Nikiforov V.V., Zaytsev A.A. et al. Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection. Terapevticheskii arkhiv [Therapeutic Archive]. 2022; 94 (1): 83–93. DOI: https://doi.org/10.26442/00403660.2022.01.201345 (in Russian)

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CHIEF EDITOR
Aleksandr V. Gorelov
Academician of the Russian Academy of Sciences, MD, Head of Infection Diseases and Epidemiology Department of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko ofRussian University of Medicine, Ministry of Health of the Russian Federation, Professor of the Department of Childhood Diseases, Clinical Institute of Children's Health named after N.F. Filatov, Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Deputy Director for Research, Central Research Institute of Epidemiology, Rospotrebnadzor (Moscow, Russian Federation)

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