Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)

NCT04811339 | Completed Phase 4 Results FDA Drug

• 1 other identifier: SABER-C 20.0636
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea; COVID-19

Outcome Measures

Primary Outcomes (1)

• Measure of Daily Stool Frequency for Patients With COVID Treated With Bismuth

  Number of bowel movements recorded over the 3 day study. Baseline (BL) /day1 + Day 2 + Day 3

  3 days

Secondary Outcomes (1)

• Salivary SARS-CoV2 Day 3 Status Using Reverse-transcription Loop-mediated Isothermal Amplification (RT-LAMP)

  Day 3 - or 48 hours after starting BSS

Study Arms (2)

Open label BSS

EXPERIMENTAL

All patients will be assigned to the treatment group for the first 10 patients treated with open label BSS.

Drug: Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable

Randomized BSS or Placebo

PLACEBO COMPARATOR

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.

Drug: Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable; Other: Placebo oral tablet without BSS

Interventions

Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable DRUG

Pepto bismol (bismuth subsalicylate)

Also known as: Pepto Bismol

Open label BSS; Randomized BSS or Placebo

Placebo oral tablet without BSS OTHER

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

Randomized BSS or Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in the study, patients must meet the following criteria: Ability to provide written or remote informed consent (telephone and DocuSign) Ability to comply with study requirements, Men or women 18 to 85 years of age, inclusive Current diagnosis of an initial occurrence of non-severe, non-complicated COV+ infection as defined by:
• Presence COVID-19 in the saliva using point of care (POC) Qualitative real time - polymerase chain reaction (QRT- PCR) assay.
• Management in an outpatient (i.e., non-hospital) or inpatient setting NOT on a ventilator.
• Alert and awake
• Able to chew the study drug completely.
• Women should fulfill one of the following criteria:
• Answer in the affirmative that "they are not or could not be pregnant"
• Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone \>20 mIU/mL (milli-International units)
• Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation.
• Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from Screening through the 21 Day visit, per Section 10.2.
• Standard of care COVID-19 treatment is acceptable.

You may not qualify if:

• Patients with any of the following will be excluded from admission into the study:
• Existence of an intra-abdominal abscess, enteric fistula, or symptomatic bowel obstruction
• History of allergy to salicylates.
• History of short gut syndrome, active ulcer or recent history of GI bleeding or melena.
• Systemic chemotherapy for the treatment of cancer during the 60 days prior to consent or planned during the study
• Active use of remdesivir.
• vaccination for COVID within 30 days.
• Current use of drugs that control diarrhea or affect peristalsis (e.g., loperamide. Opiates can be used in hospitalized patients and with outpatients if they are prescribed to a patient), or any anticipated use during the study
• Active drug, chemical, or alcohol dependency as determined by Investigator through history or urine toxicology screen
• Severe acute illness unrelated to COVID-19
• Pregnant, breast-feeding, or considering becoming pregnant during the study
• Planned hospitalization or surgery during the study
• Any medical, psychiatric, social, or other circumstances that may interfere with study compliance, completion, or accurate assessment of study outcomes

Sponsors & Collaborators

• University of Cincinnati: lead
• Procter and Gamble: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (2)

• Yacyshyn MB, Collins J, Chua M, Siegwald A, Yacyshyn S, Briones-Pryor V, Yacyshyn B. Feasibility study of Bismuth Subsalicylate (BSS) as an addition to standard of care for COVID-19 therapy. Curr Ther Res Clin Exp. 2022;96:100667. doi: 10.1016/j.curtheres.2022.100667. Epub 2022 Mar 30. No abstract available.

  PMID: 35370296 BACKGROUND

• Brum JM, Gibb RD, Ramsey DL, Balan G, Yacyshyn BR. Systematic Review and Meta-Analyses Assessment of the Clinical Efficacy of Bismuth Subsalicylate for Prevention and Treatment of Infectious Diarrhea. Dig Dis Sci. 2021 Jul;66(7):2323-2335. doi: 10.1007/s10620-020-06509-7. Epub 2020 Aug 8.

  PMID: 32772204 BACKGROUND

MeSH Terms

Conditions

Diarrhea; COVID-19

Interventions

Tablets; Dioctyl Sulfosuccinic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

1. Changing Standard of Care. 2. Patients, floor nurses and coordinators did not always keep track of number of pills taken. 3. For better compliance, we needed to decrease number of pills/day from 24 or 8 per day. 4. Transportation after discharge and sample collection needed to be optimized. 5. There was surprising difficulty in recruiting and maintaining patients in the trial during the first year, prior to general vaccine availability. 25 patients consented and never received drug.

Results Point of Contact

• Title: Dr. Bruce Yacyshyn
• Organization: University of Cincinnati

yacyshbr@ucmail.uc.edu

513-633-8715

Study Officials

• Bruce Yacyshyn, MD

  Adjunct Professor Systems Physiology and Pharmacology University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Member of research team not involved in patient care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open label trial of Bismuth subsalicylate (10 patients) followed by a second, placebo controlled study (50 patients) for mild to moderate COVID-19+ patients.

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 23, 2021
• Study Start: October 27, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)