Prevention of COVID-19 coronavirus infection with aminodihydrophthalazinedione sodium (Galavit®) in medical staff of the “red zone”: results of the multicenter observational study

Abstract

COVID-hospital healthcare workers belong to a high-risk SARS-CoV-2 infection. The aminodihydrophthala-zinedione sodium (Galavit®) belongs to the group of immunomodulatory and anti-inflammatory drugs. It has been shown that aminodihydrophthalazinedione sodium is effective in the prevention of acute respiratory infections, respiratory tract diseases and ENT-organs of bacterial and viral etiology.

The purpose of the study. To evaluate the effectiveness and safety of immunoprophylaxis of new coronavi-rus infection (COVID-19) with aminodihydrophthalazinedione sodium in healthcare workers providing medical care in the "red zone".

Material and methods. A multicenter prospective-retrospective observational comparative non-randomized study in healthcare workers providing medical care in the "red zone" was conducted. 428 participants were included in the study: the observation group - healthcare workers who administered aminodihydrophthalazinedione sodium (Galavit®) for prophylactic purposes (n=214), and control group (n=214). The observation period of the participants or the period of collecting retrospective data in the study was 30 days. The results of PCR tests and tests for antibodies to the SARS-CoV-2 were analyzed, clinical status (COVID-19 in any form) was assessed.

Descriptive statistic methods and Pearson χ2 test were used. The risk ratios, odds ratios and 95% confidence intervals were calculated with them. The influence of potential confounding factors (age, gender, work place in clinical site, the presence or absence of concomitant disease) on the clinical status were analyzed using logistic regression. The analysis of propensity score matching was carried out. The Stata /IC 14.2 for Windows software used for statistical analysis.

Results and discussion. Observational study results describe the risk ratios and odds ratios of infection with a new coronavirus (COVID-19) in healthcare workers providing medical care in the "red zone" considering prophylactic administration of aminodihydrophthalazinedione sodium (Galavit®).

205 (95.8%) participants in the group of healthcare workers who took aminodihydrophthalazinedione sodium (Galavit®) for prophylactic purposes and 194 (90.7%) participants in control group had a negative PCR test during the observation period, χ2=4.48, p=0.034. The risk of a positive status according to the PCR test for 30 days in the preventive group was 0,04, and in the control group 0.09. The risk difference was -0.05 [95% confidence interval (CI) -0.099; -0.004]. The adjusted odds ratio using multiple logistic regression was - 0.41 (95% CI 0.18-0.93).

No adverse events were observed during the prophylactic administration of aminodihydrophthalazinedione sodium over 30 days.

Conclusion. Galavit® preventive administration in a tablet form at a dose of 50-100 mg per day by employees of medical institutions providing medical care to patients with CIVID-19 significantly reduces the risk of SARS-CoV-2 infection and more than 2 times increases the chances not ill of new coronavirus infection. Galavit® administration up to 30 days at a dose of 50-100 mg was well tolerated, no adverse events were registered.

Funding. SALVIM LLC is the Sponsor of the observational study and Marketing authorization holder of the medicinal product aminodihydrophthalazinedione sodium (Galavit®). Victoriapharm LLC is the Sponsor representative in this study.

Conflict of interest. During the study Investigators received grants under an agreement with a Clinical site for the data collection from Salvim LLC.

Keywords:aminodihydrophthalazinedione sodium (Galavit®); coronavirus infection COVID-19; prevention; healthcare workers

Funding. SALVIM LLC is the Sponsor of the observational study and Marketing authorization holder of the medicinal product aminodihydrophthalazinedione sodium (Galavit®). Victoriapharm LLC is the Sponsor representative in this study.

Conflict of interest. During the study Investigators received grants under an agreement with a Clinical site for the data collection from Salvim LLC.

For citation: Kolesov S.V., Mozheyko M.E., Trufanov G.S., Gorbatyuk D.S. Prevention of COVID-19 coronavirus infection with aminodihydrophthalazinedione sodium (Galavit®) in medical staff of the "red zone": results of the multicenter observational study. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2022; 11 (1): 93-101. DOI: https://doi.org/10.33029/2305-3496-2022-11-1-93-101

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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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