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NCT04479202: BOIFIM

The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19

Completed Phase 4 Last updated 21 July 2020
What this trial tests

Phase 4 trial testing Berberine in Berberine in 76 participants. Completed in 23 April 2020.

Timeline
8 February 2020
Primary endpoint
18 April 2020
23 April 2020

Quick facts

Lead sponsorChinese Medical Association
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment76
Start date8 February 2020
Primary completion18 April 2020
Estimated completion23 April 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese Medical Association

Who can join

Adults 18 to 80, any sex, with Berberine or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

  1. Role of Gut Microbiome in COVID-19: An Insight Into Pathogenesis and Therapeutic Potential.
    Hussain I, Cher GLY, Abid MA, Abid MB. · · 2021 · cited 53× · PMID 34721437 · DOI 10.3389/fimmu.2021.765965
  2. TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.
    Kaushik D, Bhandari R, Kuhad A. · · 2021 · cited 45× · PMID 33857397 · DOI 10.1080/14728222.2021.1918103
  3. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  4. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
    Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761
  5. Current Understanding of the Innate Control of Toll-like Receptors in Response to SARS-CoV-2 Infection.
    Jung HE, Lee HK. · · 2021 · cited 31× · PMID 34834939 · DOI 10.3390/v13112132
  6. Alkaloids as Potential Phytochemicals against SARS-CoV-2: Approaches to the Associated Pivotal Mechanisms.
    Majnooni MB, Fakhri S, Bahrami G, Naseri M, et al · · 2021 · cited 24× · PMID 34104202 · DOI 10.1155/2021/6632623
  7. Phytochemicals: Potential Therapeutic Interventions Against Coronavirus-Associated Lung Injury.
    Majnooni MB, Fakhri S, Shokoohinia Y, Kiyani N, et al · · 2020 · cited 24× · PMID 33658931 · DOI 10.3389/fphar.2020.588467
  8. Human Milk Oligosaccharides: Potential Applications in COVID-19.
    Chutipongtanate S, Morrow AL, Newburg DS. · · 2022 · cited 22× · PMID 35203555 · DOI 10.3390/biomedicines10020346

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