Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Condition: Diarrhea; COVID-19
MeSH terms: COVID-19; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The Center for Disease Control (CDC) and World Health Organization (WHO) have deemed the
      COVID-19 virus a global pandemic of unprecedented severity in modern times. In 2019, this
      novel Coronavirus (COVID-19) emerged from the Asian continent and has now caused upwards of
      1million deaths and over 6 million infections globally. Currently, the estimated global
      economic impact is over 5 Trillion dollars. Understanding the host response to pathogens,
      specifically the cellular and humoral responses, has played an important role in new
      non-antibiotic therapies. Bismuth subsalicylate (Pepto-Bismol) has a potential role in the
      clearance and/or recurrence of enteric viral infections.
    

Detailed description: 
      Readily available over-the-counter (OTC) medication for symptomatic relief and appropriate
      oral hydration can be health saving measures of great convenience for those affected by
      enteric bacterial and viral infections. BSS is a non-proprietary monograph product that is
      available in the USA and abroad, over-the-counter (OTC). Of all OTC medications for
      traveller's diarrhea (TD), bismuth subsalicylate (BSS) has the greatest antimicrobial
      activity against pathogenic bacteria .BSS has also exhibited significant inhibition on viral
      invasion of host cells and viral efficacy. Both BSS and bismuth oxychloride (BiOCl, which is
      formed in the stomach after ingestion of BSS) at low concentration (0.004-0.13mg/mL)
      significantly reduced norovirus (NoV) RNA levels, suggesting an in vivo antiviral mechanism.
      BSS has also been shown to have antiviral activity since it inhibited replication of 4
      strains of rotavirus in tissue culture cells and caused a dose-dependent reduction in the
      growth of several enteric viruses.

      Historically, BSS has been indicated and effectively used for the treatment of TD or enteric
      infection, mainly when vomiting occurs. Although the safety and efficacy of BSS is well
      known, some of the research done with BSS resides within the industry and have not been
      published. We have recently completed an extensive meta-analysis using unpublished clinical
      studies regarding BSS safety and efficacy. Meta-analyses of randomized controlled clinical
      trials were performed with studies specifically designed to capture prevention of
      manifestation and relief of diarrhea.
    

Intervention name(s): Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable; Placebo oral tablet without BSS
Intervention type(s): Drug; Other
Intervention description(s): Pepto bismol (bismuth subsalicylate); Placebo Tablet made by P & G to contain everything except active ingredient ( BSS)
Other intervention name(s): Pepto Bismol
Intervention MeSH terms: Bismuth; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label trial of Bismuth subsalicylate (10 patients) followed by a second, placebo controlled study (50 patients) for mild to moderate COVID-19+ patients.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment