Protection From SARS-CoV-2 Infection With an Oral Nosode (BiosimCovex): A Randomized, Double-Blind, Placebo-Controlled, Phase III Study.

ABSTRACT:

Background and objectives

This study investigated a potentized, oral homeopathic SARS-CoV-2 nosode (BiosimCovex) for safety, efficacy, and immunogenicity against COVID-19 infection.

Methods

A phase III, multicentre, randomised, double-blind, placebo-controlled trial was conducted at 13 sites in India. 2671 unvaccinated, RT-PCR and SARS-CoV-2 antibody-negative participants were randomized 2:1 to receive 6 doses over 3 days of BiosimCovex (1781) or placebo (890). SARS-CoV-2 prevention efficacy was assessed through RT-PCR. Efficacy was defined as 100 x (1-IRR), where IRR is the ratio of positive RT-PCR test rates in the BiosimCovex compared to the placebo group. A two-sided Clopper-Pearson 95% confidence interval was adjusted for surveillance time. Immunogenicity was measured b

SUBMITTER: Shah R 

PROVIDER: S-EPMC12501439 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature