Kshitij Mody* and Sankeerth Thoota

Department of Orthopaedics, Welcare Hospital, India

*Corresponding Author: Kshitij Mody, Department of Orthopaedics, Welcare Hospital, India.

Received: August 19, 2021; Published: September 08, 2021

Abstract

Background: A prospective, double arm, placebo control, single blinded, investigator led research study was performed to assess the strength of an oral spray formulation, containing 8.4% sodium bicarbonate as its active ingredient, in offering a barrier to the development of Influenza Like Illnesses (ILI) including Covid-19 infection and to evaluate the safety and tolerability of the spray in subjects with repeated daily use for 28 consecutive days.

Methods: 350 subjects were enrolled, 175 in the active product group and 175 in the placebo control group. Randomisation was achieved by block randomisation technique. Subjects in the active product group were given the Investigational Product (IP) and subjects in the placebo control group were given the Placebo Product (PP). Monitoring of recruited subjects was done based on a USFDA approved Patient Reported Outcome Measure (PROM) methodology. Subject Diaries were issued to all subjects to record data and daily monitoring was carried out by telephone. All subjects were monitored in person on Day 1, Day 15 and Day 28.

Results: It was seen that a significantly lower number of subjects using the Investigational Product recorded any ILI symptoms as compared to the subjects using Placebo Product.

Conclusion: The results establish that the oral spray formulation used in this study is effective in mitigating SARS-CoV-2-enveloped virus-related activity by creating an alkaline pH environment in the oropharyngeal spaces.

Keywords: Covid-19; Sodium Bicarbonate; Oral Spray

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Citation

Citation: Kshitij Mody and Sankeerth Thoota. “The Role of an Oral Spray of a Formulation Containing 8.4% Sodium Bicarbonate in Preventing COVID 19 and Other Influenza Like Illness in Humans”. Acta Scientific Microbiology 4.10 (2021): 03-10.

Copyright

Copyright: © 2021 Kshitij Mody and Sankeerth Thoota. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.