CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable +1 moredrug
Likely dose
Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewablefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04811339
NCT04811339Phase 4Completed
CompareCT.gov

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)

University of Cincinnati·interventional·Posted Mar 23, 2021·Updated Mar 1, 2023

In Brief

A Phase 4 clinical trial evaluating Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable and Placebo oral tablet without BSS for Diarrhea and COVID-19. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea, COVID-19
CountriesUnited States
CollaboratorsProcter and Gamble

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 23, 2021
Enrollment StartOct 27, 2020
Primary CompletionAug 15, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.3 years ago

Interventions

Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewabledrug

Pepto bismol (bismuth subsalicylate)

Placebo oral tablet without BSSother

Placebo Tablet made by P \& G to contain everything except active ingredient ( BSS)