(P14-007-24) BV-4051, Artovid-20®, an Ayurvedic Polyherbal Product Significantly Lowers Interleukin-6 and Symptoms Severity in Moderate SARS-CoV-2 Infected Hospitalized Patients

Objectives: SARS-CoV-2 is still having long standing effects in our everyday life. It was a global epidemic and we lost millions of people worldwide. It continues to have a notable impact in daily health, wellness and work productivity. The latest variant JN.1 has the ability to evade immune responses and infect vaccinated individuals. We studied a standardized oral polyherbal formulation BV-4051 (Artovid-20®), from four Ayurvedic plants namely Ashwagandha, Boswellia, Ginger and Turmeric; for the treatment of moderate COVID-19 subjects. This combination has shown previous inhibition of several inflammatory markers including several cytokines.

Methods: In this Phase III Randomized Clinical Trial, moderate COVID-19 patients (mostly Delta variant) were randomly assigned to receive BV-4051 along with Standard of Care (SOC) tablets or placebo, for 14 days, at four hospital sites. The primary parameter was reduction in duration and severity of illness. Secondary parameters were reduction of duration and severity scores of individual symptoms, and assessment of different biomarkers. A sub-set analysis of subjects given Remdesivir as standard of care was conducted.

Results: Total 208 subjects were randomized and 175 completed 14 days of treatment. The groups were well matched for gender, age, race, weight, height and BMI. The median reduction in duration of illness (p=0.036) and alleviation of several symptoms including taste and smell was statistically significant. Similar statistically significant results were seen in BV-4051 taken with Remdesivir. Mean difference in Interleukin-6 from Day 1 to Day 14 was statistically significant (p=0.042) on BV-4051 without Remdesivir. Other inflammatory markers were lowered but did not reach significance. Thirteen adverse events were reported in 5 subjects and resolved during the study.

Conclusions: BV-4051 can reduce symptoms severity, duration of illness and prevent the incidence of COVID-19 complications. It helps in reduction of Interleukin-6. It reduces the duration of illness and symptoms severity combined with Remdesivir; and may have an adjunctive effect with other standard of care. BV-4051 is safe in moderate SARS-CoV-2 infection, and may be implicated in Long COVID complications and in other respiratory viral illnesses as a natural immunity booster.

Funding Sources: Bioved Pharmaceuticals, Inc., San Jose, CA-95131