Biotechnology company Entera Health reported on Thursday the receipt of the IRB approval to commence a clinical trial in Barcelona Spain using EnteraGam to manage the symptoms associated with COVID-19 infections in partnership with Lemus Buhils.

The companies said EnteraGam (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. It is administered under medical supervision in the USA.

Titled "Randomized Open-Label Clinical Study Evaluating the Impact of EnteraGam, a Nutritional Intervention containing Bovine Plasma-Derived Immunoglobulin CoNcentrate, on Clinical Outcomes In People with COVID-19 (Spanish PICNIC Study)" , the trial will investigate the use of EnteraGam to manage inflammation and symptom severity in patients with mild-to-moderate SARS-CoV-2 infections.

This randomized open-label Spanish PICNIC clinical trial aims to enroll 420 subjects with SARS-CoV-2 infection with mild-to-moderate symptom severity, including respiratory distress, coughing and shortness of breath. The primary endpoints of the trial are the change in plasma IL-6 levels between entry and the percentage of patients with disease progression by Week two, concluded the partnership.