Entera Health, in cooperation with Lemus Buhils, has received IRB approval to conduct a clinical trial in Barcelona Spain using EnteraGam to manage the symptoms associated with COVID-19 infections. The trial 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)" will investigate the use of EnteraGam to manage inflammation and symptom severity in patients with mild-to-moderate SARS-CoV-2 infections.
The Spanish PICNIC Study is a randomized open-label clinical trial which aims to enroll 420 subjects with SARS-CoV-2 infection. Patients will be randomized in a 2:1 ratio to receive EnteraGam in addition to standard of care, or standard of care alone. Patients enrolled in this trial will have mild-to-moderate symptom severity, including respiratory distress such as coughing and shortness of breath, but will not require invasive mechanical ventilation or management in the intensive care unit. The primary endpoints of the trial are the change in plasma IL-6 levels between entry and Week 2, and the percentage of patients with disease progression by Week 2. A number of secondary endpoints will focus on specific COVID-19 associated symptoms, including diarrhea, and other markers of gut associated inflammation and permeability.
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"Many COVID-19 studies focus on patients who have severe disease. With this study, we are assessing a serum protein supplement to see if it has the potential to prevent progression to severe disease by decreasing inflammation," Netanya Utay, MD, Assistant Professor at McGovern Medical School at The University of Texas Health Science Center at Houston, Principle Investigator of the trial, said.
"We appreciate the effort of everyone involved in the development of this clinical trial. The effort, collaboration, and speed at which this trial has become a reality is nothing short of amazing. During these uncertain times, everyone is looking for opportunities to help those affected most by COVID-19, this trial is our effort to advance the understanding of COVID-19 and help a population with mild disease return to a normal state of health faster," Aage Lauridsen, CEO of Entera Health, said.