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Open label BSS for COVID-19 (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

SABER-C Trial Summary

This trial will investigate whether or not bismuth subsalicylate can help treat or even prevent the novel coronavirus.

Eligible Conditions
  • COVID-19
  • Diarrhea
  • Coronavirus

SABER-C Trial 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

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

SABER-C 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
428 Previous Clinical Trials
634,326 Total Patients Enrolled
1 Trials studying COVID-19
32 Patients Enrolled for COVID-19
Procter and GambleIndustry Sponsor
146 Previous Clinical Trials
76,520 Total Patients Enrolled
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,924 Total Patients Enrolled
1 Trials studying COVID-19
250 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are commonly treated with open label BSS (pepto Bismol)?

"Open label BSS (pepto-Bismol) is regularly prescribed for curling ulcers, and may also prove beneficial in the case of helicobacter pylori infections, diarrheal episodes, or indigestion."

Answered by AI

To whom is this opportunity to participate in the research available?

"This clinical trial seeks 35 participants aged 18 to 85, who presently suffer from diarrhea. Other eligibility requirements include being managed in an out- or inpatient setting and not requiring a ventilator; being alert and conscious; asserting that they are not pregnant nor can become so during the study window; having undergone hysterectomy, bilateral oophorectomy, tubal ligation surgery or using effective contraception for women of childbearing potential engaging in heterosexual sexual relations."

Answered by AI

What other open-label studies have been conducted that focus on the effects of pepto Bismol?

"Currently, one open-label BSS (pepto bismol) trial is underway with no Phase 3 trials. This study is primarily conducted within Louisville, Kentucky but there are additional sites available for participation."

Answered by AI

How many persons can realistically participate in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial is presently enrolling patients and has been doing so since September 2nd 2020. It was last edited on March 23rd 2021 and requires 35 people from one site participating in the study."

Answered by AI

Is this research original or based on prior studies?

"Procter and Gamble first initiated research into open label BSS (pepto Bismol) in 2020, with a trial involving 35 participants. This study eventually reached its Phase 4 drug approval stage, making it available for public use. Currently, Procter and Gamble is the only entity sponsoring an active trial evaluating this medicine's efficacy."

Answered by AI

Is there currently an opportunity for new participants to join this experiment?

"Confirmed, this clinical trial is open to patient recruitment. The details of the study were initially posted on September 2nd 2020 and revised last March 23rd 2021."

Answered by AI

How detrimental is the use of unpackaged BSS (pepto Bismol) to human health?

"There is a considerable amount of evidence affirming the safety of open label BSS, thus it was awarded a score of 3. This treatment has received approval from regulatory bodies and is currently in Phase 4 clinical trials."

Answered by AI

Is the age range for this study confined to those over 20 years of age?

"The current research program has been established to assess the efficacy of a drug on patients aged 18-85. Conversely, there are 165 studies that focus on minors and 945 trials devoted to seniors."

Answered by AI

Who else is applying?

What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Bruce Yacyshyn 2020. "Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04811339.
~14 spots leftby Apr 2025
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