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

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 by SARS-CoV-2 antibody conversion at days 15, 30, 45, and 60. Safety was assessed through symptom questionnaires and laboratory studies every 15 days. Illness burden was assessed through symptom diaries.

RESULTS

Maximum efficacy occurred at day 45 and was 50.06% overall, 71.88% in individuals aged 18-40 years; and 61.57% in females. By day 45, there were 23 positive RT-PCR cases per group (BiosimCovex 1.3%; placebo 2.6%, P = 0.007). A total of fifty-nine positive RT-PCR cases occurred, with thirty-three (1.86%) in the BiosimCovex and twenty-six (2.94%) in the placebo group, for a relative risk (RR) of 0.63 at the end of the study over 60 days. Antibody conversion increased over time, with 48.4% becoming antibody positive by day 60 in the treatment group compared to 13.4% in the placebo group (P < 0.001). All 169 (6.33%) mild adverse events resolved without sequelae (6.52% in treatment; 5.96% in placebo). There was a significant reduction in symptom duration (P = 0.0085) in the treatment group for those who became ill.

CONCLUSIONS

A potentized oral nosode was safe and appeared to prevent SARS-CoV-2 infection and be immunogenic over 60 days. Effectiveness was highest at day 45 in females and in the 18- to 40-year-old age group.