AT1001 for the Treatment of Long COVID

AT1001 (Larazotide) is a locally acting, non-systemic, octapeptide inhibitor of the zonulin receptor that has shown efficacy in a large variety of animal models of inflammation. The effectiveness of AT1001 in controlling paracellular permeability as a tight junction regulator has been widely demonstrated in animal models both in vitro and in vivo. In MIS-C, prolonged presence of SARS-CoV-2 in the GI tract leads to release of zonulin, a biomarker of intestinal permeability, with subsequent trafficking of SARS-CoV-2 antigens into the bloodstream, leading to hyperinflammation (Yonker, et. al. 2021). Five children treated with AT1001 (through an Emergency Investigational New Drug request authorized by the FDA) displayed a decrease in plasma SARS-CoV-2 Spike antigen levels, inflammatory markers, and symptom improvement superior to that achieved with the current standard of treatment for MIS-C (ie. immunoglobulin, systemic steroids) (Yonker, et. al. 2021) (Yonker, et. al. 2022)

Matching placebo will be administered orally four times a day (QID) to participants in the placebo arm.