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

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The CDC and 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: Procter and Gamble
• Treatments: Bismuth subsalicylate

Criteria

Inclusion Criteria:

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 POC 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

• 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.

Exclusion Criteria:

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 remdisivir.

• 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

• Enrollment in any other investigational drug or device study known to interfere with Pepto bismol (bismuth subsalicylate) within the GI tract, within 30 days prior to Randomization (Day 1) or within 5 half-lives of the last dose of the previous investigational compound, whichever is longer. Vaccines are not exclusionary as they do not interfere with the mechanism of the study drug.

• 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