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Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol) (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
Drug Has Already Been Approved
Pivotal Trial
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
- Bile Acid Diarrhea
- Diarrhea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3 - or 48 hours after starting bss
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3 - or 48 hours after starting bss
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)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
438 Previous Clinical Trials
638,628 Total Patients Enrolled
Procter and GambleIndustry Sponsor
147 Previous Clinical Trials
76,638 Total Patients Enrolled
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,641 Total Patients Enrolled
Bruce Yacyshyn, MDPrincipal Investigator - Adjunct Professor Systems Physiology and Pharmacology University of Cincinnati
University Of Louisville Research Foundation, University of Cincinnati Medical Center, University of Louisville Hospital
University Of Alberta (Medical School)
Toronto Gen Hospital (Residency)