Anti-Inflammatory Activity of A Full Spectrum CBD- Rich Hemp Formulation in Patients with COVID-19 Infection

Abstract

Abstract Background: The coronavirus disease-19 (COVID-19) pandemic is attributable to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The pathogenesis of SARS-CoV-2 is attributed to the activation of multiple inflammatory pathways secondary to the interaction of virus and host immune responses. 15% of patients over the age of 60 with COVID-19 require hospitalization. In addition, ICU admissions are as high as 5% of COVID-19 patients in this same age group. Most with one or more underlying conditions, undergo the pathophysiologic process of hyper-inflammation and its accompanying Cytokine Storm Syndrome (CSS) which results in significant morbidity and mortality. Therapeutics, which reduce the release of inflammatory cytokines, have been sought to slow disease progression. A growing body of literature attests to the anti-inflammatory effects of the naturally occurring cannabinoids found in both cannabis and hemp plants. The major cannabinoid, cannabidiol (CBD), results in decreased cytokine production via Cannabinoid receptor 2 (CB2). In addition, recent evidence indicates: (1) CBD may protect against infection by inducing anti-viral cellular activity; and (2) two specific cannabinoids exhibit binding to the spike protein thereby preventing infection in vitro. Therefore, examination of the activity of a CBD-rich oil on cellular inflammatory markers, as a potential natural intervention and as an adjuvant to recognized therapeutic interventions, is considered here. Materials and methods: COVID-19 has influenced all sectors of the world’s economic, scientific and commercial communities. This is true also of the investigative work within this report which adapted to the COVID-19 outbreak during the execution of the study. Part 1 of this report focuses on the initial study designed to evaluate the reported anti-inflammatory effects of a hemp-based full-spectrum CBD and cannabinoid-rich microcellular formulation (i.e. Hempzorb81™) on healthy volunteers comparing a treatment group of 100 with a placebo group of 50. Part 2 extends the report to the effects of the Hempzorb81™ formulation on a subset of 44 study subjects who tested positive for COVID-19 infection compared to a 39 subject COVID-19 negative test control group. Results: In Part 1, the treatment cohort found two cytokines associated with the development of SARS-CoV-2. Both TNFα and IL-6 showed statistically significant reductions compared to placebo in healthy patients. Two inflammatory markers, ESR and CRP, showed reductions of 19.4% and 12.5%, respectively, but the results were not statistically significant. In Part 2, TNFα, CRP, IL-1,6 and White Blood Cell count (WBC) all showed statistically significant p-values in the COVID-19 positive cohort. In the course of the study, no COVID-19 positive patients were hospitalized or died. A 2-fold reduction in white blood cell count at the time of diagnosis over the treatment course was an additional significant indicator for improved outcome post-infection.