A double blind, randomized, placebo-controlled study to evaluate efficacy and safety of “ViraCide” in the management of Corona Virus Disease 2019 (COVID-19)

Abstract

Introduction: The purpose of this study was to evaluate the safety and efficacy of ViraCide in the management of Corona Virus Disease 2019. Methodology: The study was a randomized, multi center, parallel design, placebo controlled, double blind, clinical trial in patients diagnosed with corona virus disease 2019 with mild or no symptoms and with stable co-morbidities. 118 enrolled subjects were randomized in a 1:1 ratio to either placebo treatment or ViraCide (active treatment). Result: The primary efficacy parameters of National Early Warning Score (NEWS) and 7 point ordinal showed a significantly greater improvement in the active group at the end of the study (P < 0.05). In case of NEWS, in the ViraCide group at visit 3, 74.6 % of the subjects had score of “0” which was higher than the placebo in which only 49.2% showed the reduction. In case of the 7 point ordinal scale, in the active group 76.3 % of the subjects had score of 1 which is significantly higher than that of placebo group which is only 47.5%. Time taken for clinical improvement with respect to negative RT PCR test also showed significant difference in the active v/s placebo group. The mean time taken by patients in the active group to test negative was 5.47 days which was significantly lower than placebo which was 6.97 days. The adverse events rate and severity were comparable in both the groups and no clinically significant adverse event was found in the active or placebo group. Conclusion: The use of ViraCide in mild or asymptomatic COVID-19 patients showed time frame reduction with respect to RT-PCR test, as well as clinical improvement demonstrated by NEWS and 7-point ordinal scale and certain laboratory parameters. Further clinical trials are required to evaluate role of ViraCide in managing COVID-19 and establish its mode of action.