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

Abstract

Introduction: BiosimCovex, a coronavirus nosode’s biological preparation was sourced from preclinical samples. The study needs to investigate the acute, subacute oral toxicity of different homeopathic drugs. The acute, subacute, repeat dose toxicity and safety testing of this newly developed nosode were conducted as per the OECD and New Drug and Clinical Trial (NDCT 19) rules. Material and methods In acute, subacute, repeat dose toxicity study, the homeopathic drug was administered orally at body weight, and animals were observed for toxic symptoms for 14 days. The study design consisted of 10 animals (05 males and 05 females) in acute mice and rats, 48 animals (24 males and 24 females) in subacute/repeat dose rats, and 24 (12 males/12 females) in repeat dose rabbit studies. Results Results indicate that in the acute and subacute studies of the rat and mice, no mortalities or clinical signs were found. 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 in other groups body weight gain observed was normal. The clinical signs were found to be normal in rats and rabbits. Histopathology results reveal that the 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 repeat dose studies using BiosimCovex, a coronavirus nosode.