Clinical trial NCT04811339
Conditions: Diarrhea COVID-19
Sponsor: University of Cincinnati
Start date: 2020-10-27; Completion date: 2021-08-15
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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 We have recently completed an extensive meta-analysis using unpublished clinical studies regarding BSS safety and efficacy.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.

Arms: arm 1: All patients will be assigned to the treatment group for the first 10 patients treated with open label BSS. arm 2: The Subsequent 50 patients will be randomized to either placebo or BSS. The patients will be assigned by envelope containing a symbol for either active drug or placebo (or other suitable randomization event) by a member of the research team not directly involved in the clinical trial.
Interventions: intervention 1: Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable intervention 2: Placebo oral tablet without BSS
Intervention descriptions: intervention 1: Pepto bismol (bismuth subsalicylate) intervention 2: Placebo Tablet made by P \& G to contain everything except active ingredient ( BSS)

Protocol documents:
ICF_001.pdf: 



















Prot_SAP_002.pdf: 
CLINICAL PROTOCOL NCTO4811339
A 3 day open label, Pilot study followed by an-up to 21 day double-blind study to assess stool 
frequency ofCOVID + patients treated with oral bismuth subsalicylate (Pepto-Bismol): 
SABER-C 
(Specific Administration of Bismuth for Early Recovery of COVID-19) 
PROTOCOL DA TE: 
DEVELOPMENT PHASE: 
PRODUCTS: 
INVESTIGATORS: 
Version Date: 1, 1312021 v9 
13JAN202l 
IV 
Chewable Pepto-bismol (bismuth subsalicylate tablets) 
and matched placebo 
Dr. Bruce Y acyshyn (PD 
Dr James Collins (co-Investigator) 
550 South Hancock 
CTR building 
UniveFSity of Louisvi Ile 
Louisville, KY 402.02