NCT04682041: PICNIC

Evaluating the Impact of EnteraGam In People With COVID-19

Completed NA Last updated 20 April 2023

What this trial tests

NA trial testing Bovine Plasma-Derived Immunoglobulin Concentrate in Covid19 in 200 participants. Completed in 21 February 2022.

Timeline

22 December 2020

Primary endpoint
20 December 2021

21 February 2022

Quick facts

Lead sponsor	Entera Health, Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	22 December 2020
Primary completion	20 December 2021
Estimated completion	21 February 2022
Sites	1 location across Spain

Drugs / interventions tested

• Bovine Plasma-Derived Immunoglobulin Concentrate
• Standard of care

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Entera Health, Inc

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged as a potentially life-threatening disease in Wuhan, China, at the end of 2019. Since then, it has spread to almost 200 countries and infection rates are rapidly accelerating.

Overactivation of T cells resulting in immune dysfunction, dysfunction of the renin angiotensin system, and antibody-dependent enhancement are thought to contribute to the cytokine storm that results in acute respiratory distress syndrome (ARDS), culminating in death. In addition to causing respiratory symptoms, SARS-CoV-2 can cause diarrhea and has been isolated from the stool. SARS-CoV-2 binds to Angiotensin-converting enzyme 2 (ACE2) on lung alveolar type 2 cells, but ACE2 is also expressed in the absorptive enterocytes from the ileum and colon. The diarrhea may be caused by increased intestinal permeability due to binding of these receptors by the SARS-CoV-2.

Thus, an intervention to attenuate this cytokine storm may improve clinical outcomes in people with COVID-19. One such intervention is oral administration of serum bovine immunoglobulins, which decreases interleukin-6 (IL-6) levels safely with minimal side effects. Animal and human clinical studies have shown dietary supplementation with oral immunoglobulins improves mucosal immunity, specifically respiratory/pulmonary and GI mucosa, and decreases systemic inflammation, reducing the symptoms and severity of pulmonary inflammation and viral infections.

Hypothesis:

Dietary supplementation with EnteraGam® will decrease IL-6 levels and prevent disease progression in SARS-CoV-2 infected individuals.

Objectives:

To evaluate the effectiveness of the oral nutritional therapy EnteraGam® (serum-derived bovine immunoglobulin/protein isolate) to prevent disease progression of COVID-19 and to decrease IL-6 levels as compared to standard of care in subjects with COVID-19.

Methods:

Randomized open-label clinical study evaluating the effectiveness of EnteraGam® 10.0 g BID (every 12 hours) added to standard of care, as compared to standard of care alone, in subjects with COVID-19.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
   Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7
2. Immunoregulatory Effects of Porcine Plasma Protein Concentrates on Rat Intestinal Epithelial Cells and Splenocytes.
   Hernández-Chirlaque C, Aranda CJ, Ocón B, Polo J, et al · · 2021 · cited 5× · PMID 33805697 · DOI 10.3390/ani11030807
3. Potential use of serum-derived bovine immunoglobulin/protein isolate for the management of COVID-19.
   Utay NS, Asmuth DM, Gharakhanian S, Contreras M, et al · · 2021 · cited 3× · PMID 34110032 · DOI 10.1002/ddr.21841