Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811339
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2021-03-20
Brief Title:
Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate Pepto-Bismol
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Pilot and Randomized Controlled Studies to Assess Stool Frequency of COVID Patients Treated With Oral Bismuth Subsalicylate Pepto-Bismol SABER-C and Lite-SABER-C Specific Administration of Bismuth for Early Recovery of COVID-19
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABER-C
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 andor 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 travellers 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 0004-013mgmL 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None