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Open label BSS for Coronavirus (SABER-C Trial)

Phase 4
Waitlist Available
Led By Bruce Yacyshyn, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3 - or 48 hours after starting bss
Awards & highlights

Summary

This trial investigates Pepto-Bismol as a treatment for people with gut infections. The medicine works by reducing the ability of viruses to invade and spread in the gut, potentially lowering infection levels. Bismuth preparations, including Pepto-Bismol, are commonly used to treat a variety of stomach issues, and they have an excellent safety profile with mild, short-term, and infrequent side effects.

Eligible Conditions
  • Coronavirus
  • Diarrhea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3 - or 48 hours after starting bss
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3 - or 48 hours after starting bss for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure of Daily Stool Frequency for Patients With COVID Treated With Bismuth
Secondary study objectives
Salivary SARS-CoV2 Day 3 Status Using Reverse-transcription Loop-mediated Isothermal Amplification (RT-LAMP)

Side effects data

From 2021 Phase 4 trial • 60 Patients • NCT04811339
33%
Abdominal bloating
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label BSS Therapy - Those Who DID NOT Complete
Open Label BSS Therapy -Completed
Cancelled SOC Control Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Open label BSSExperimental Treatment1 Intervention
All patients will be assigned to the treatment group for the first 10 patients treated with open label BSS.
Group II: Randomized BSS or PlaceboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable
2020
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
433 Previous Clinical Trials
636,343 Total Patients Enrolled
Procter and GambleIndustry Sponsor
146 Previous Clinical Trials
76,518 Total Patients Enrolled
University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,273 Total Patients Enrolled
~12 spots leftby Sep 2025
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