Comparative efficacy and safety of preventive treatment with cytovir-3 and arbidol in children during seasonal outbreak of respiratory viral infection (an open-label randomized clinical study)

V S Smirnov,N I Zavialova,M K Erofeeva,A V Lyovina,S A Saveliev,G Redlich,S V Petlenko

doi:10.15789/2220-7619-2019-2-273-278

Abstract

Aim: To compare the safety and prophylactic efficacy of Cytovir-3 and Arbidol in an open-label randomized clinical trial in children at seasonal risk of infectious respiratory disease.Methods: This study was performed in the period preceding a seasonal outbreak of acute respiratory viral infections (ARVI) and influenza. The study enrolled apparently healthy children aged 6 to 18 years without contra-indications to either Cytovir-3 or Arbidol. Cytovir-3 was given as 1 capsule per day, each day in a fasted state for 12 days. Arbidol was taken as a 100 mg capsule twice a week for three weeks. Following dosing, subjects were followed-up for a further three weeks. Overall health and presence of symptoms of either ARVI or influenza were monitored daily in all subjects. The level of sIgA in saliva was baselined before treatment and measured at the end of the follow-up period.Results: Most subjects did not exhibit any change in overall health status during the dosing and follow-up periods. The first two cases of illness in subjects receiving Cytovir-3 were diagnosed at the end of the third week after completion of dosing. In those subjects receiving Arbidol the first cases of illness were reported at the end of the second week following the end of prophylactic dosing. All patients displayed a significant increase in sIgA level at the end of the dosing period, but this was more pronounced in the Cytovir-3 group. Conclusion: The results of this comparative randomized clinical trial confirmed the safety and tolerability of both medications, and that the prophylactic efficacy of Cytovir-3 is equal to that of Arbidol.

Highlights

MethodsThe current study enrolled 207 healthy children aged 6 to 18 years (boys: 119 or 57.4%; girls: 88 or 42.63%) attending childcare facilities in pre-schools or secondary schools and who matched the inclusion criteria
There were no significant differences in heart rate between Cytovir-3 and Arbidol groups (81.9±6.0 and 81.7±7.8, respectively) and body temperature (36.3±0.2°С and 36.4±0.2°С, respectively)
During the third and final week, in the Arbidol group four subjects had a positive diagnosis but only two were diagnosed in the Cytovir-3 group. These results suggest that the duration of protection is three weeks for Cytovir-3 but only two weeks for Arbidol

Summary

Methods

The current study enrolled 207 healthy children aged 6 to 18 years (boys: 119 or 57.4%; girls: 88 or 42.63%) attending childcare facilities in pre-schools or secondary schools and who matched the inclusion criteria. 102 children were randomized to receive Cytovir-3 and 105 children were randomized to receive Arbidol Both legislation of the Russian Federation and the Declaration of Helsinki (rev.7, 2013) declare the use of placebo controls illegal and unethical in such clinical trials. Inclusion criteria were: boys and girls aged from 6 to 18 years without any signs of infection or intoxication, with a verified diagnosis “free of disease” (according to the decision of Ministry of Health No 621 dd 30.12.2003 classified as health group I or II), not having taken antibiotic, antiviral, hormonal or immunotropic drugs during the previous two months and not being vaccinated against influenza during the 12 preceding months.

Results

Discussion

Conclusion