The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19
Status:
Completed
Trial end date:
2020-04-23
Target enrollment:
Participant gender:
Summary
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world,
causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent
multiple organ dysfunction (MODS) are important causes for disease progression and death in
patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via
binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the
S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the
virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also
highly expressed in the esophagus, small intestine and colon, suggesting that the gut might
also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases
confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal
pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by
real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore,
elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory
response in the gut, which was significantly correlated with IL-6. For severe and critical
cases, control "cytokine storms" and maintain intestinal microenvironment balance have been
included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7).
Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used
in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland
secretion. Berberine has also been found to have a role in intestinal immune regulation,
inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the
inflammatory response. Investigators conducted a prospective randomized controlled clinical
trial to investigate the effects of berberine on intestinal function, serum concentrations of
the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.