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.