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

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
Traveler's 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

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)

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

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