Abstract

The aim of the research is to study of the efficacy and safety of VIFERON® drug, rectal suppositories (interferon α-2b) 1,000,000 IU and 3,000,000 IU, and VIFERON®, gel for external and local use (interferon α-2b) 36,000 IU/g , in the complex therapy of a сoronavirus disease 2019 (COVID-19) in children. Materials and methods of research: as part of the open multicenter prospective controlled non-randomized study, 140 patients aged 1 to 17 years with the сoronavirus disease 2019 (COVID-19) were examined, and hospitalized in the infectious diseases hospital (Krasnoyarsk interdistrict clinical hospital № 1) in Krasnoyarsk from 20.04.20 to 1.08.20. Depending on the conducted antiviral therapy, the observed patients were divided into 2 groups: the main (70 people) and control (70 people). Starting from the moment of hospitalization, the main group of patients in the complex therapy received the preparation of interferon (IFN) α-2b with antioxidants (vit E and C), rectal suppositories, and IFNα-2b, gel for external and local use, according to the proposed schemes depending on age; patients of the control group were prescribed Umifenovir (Arbidol®) in age-specific dosages. The criteria of effectiveness of the therapy were the period of treatment of the main clinical symptoms of the disease (cough, nasal congestion, runny nose, sore throat, conjunctivitis, taste and smell impairment, abdominal pain, diarrhea, etc.), elimination of viral antigen in samples from the nasopharynx and feces, product dynamics of IgM and IgG antibodies to SARS-CoV-2 in the blood serum. Results: the clinical efficacy and safety of high dose polytherapy of IFNα-2b with antioxidants, rectal suppositories in combination with IFNα-2b with antioxidants, gel for external and local use in the therapy of COVID-19 in children were confirmed. Since the appointment of therapy in patients of the main group, in comparison with the control group, the time for relief of the main clinical symptoms of COVID-19 has been statistically significantly reduced: nasal congestion – from 7 to 3 days (p=0,0001), sore throat – from 7 to 3 days (p=0,0001), hyperemia in the oropharynx – from 10 to 5 days (p=0,0001), mild cough – from 7 to 5 days (p=0,05), catarrhal conjunctivitis – from 5 to 3 days (p=0,012), smell disorders – from 10 to 4 days (p=0,001) and taste – from 10 to 4 days (p=0,001). The period of complete relief of all clinical symptoms according to the «total score» was statistically significantly reduced from 9 days in the control group to 5 days in the main group (p=0,05). The elimination time of SARS-CoV-2 from the nasopharynx was also statistically significantly reduced by 5 days in the main group of patients (p=0,05). In patients receiving increased doses of IFNα-2b with antioxidants, intestinal sanitation occurred 2,5 times more frequent, statistically significant increase in the level of IgG antibodies to SARS-CoV-2 was detected in comparison with patients of the control group (p=0,05). No adverse events were recorded in the observed patients of both groups. Conclusion: the proven efficacy and safety of combined antiviral therapy with IFNα-2b with antioxidants, rectal suppositories in combination with IFNα-2b with antioxidants, gel for external and local use, are the basis for its widespread implementation into pediatric practice for the treatment of patients with сoronavirus disease 2019 COVID-19.

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