Acute, subacute, repeated dose toxicity and safety studies of BiosimCovex (COVID-19 Nosode) in animal model.

Introduction: BiosimCovex, a coronavirus nosode was sourced from a clinical sample. Studies are necessary to investigate the acute and subacute oral toxicity of potentised drugs. The acute, subacute repeated dose toxicity and safety testing of the nosode were conducted as per the OECD and New Drug and Clinical Trial (NDCT 19) rules. Material and methods: Animals were randomized as 10 mice and rats (05 males and 05 females of each species) in acute study, 48 rats (24 males and 24 females) in subacute/repeated dose study, and 24 rabbits (12 males/12 females) in repeated dose studies. In acute, subacute, repeated dose toxicity studies, animals were orally dosed with BiosimCovex and observed for toxic symptoms for 14 days. Results: In acute and subacute studies in rats and mice, no mortalities or significant clinical signs were observed. The body weight and body weight gain in rats were normal and decreased in mice in the acute study. The feed consumption was normal for rats and mice. In male rabbits, body weight was decreased, and the weight gain was observed to be normal in other groups. In repeated dose toxicity studies in rats and rabbits, the clinical signs were found to be normal. Histopathology results reveal that BiosimCovex has not produced any major reactive and toxic changes in all the systemic organs when administered by an oral route up to a high dose. Conclusion: No toxicity was documented using acute, subacute, and repeated dose studies using BiosimCovex, a coronavirus nosode. [ABSTRACT FROM AUTHOR]