Status:
COMPLETED
Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Procter and Gamble
Conditions:
Diarrhea
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 (CO...
Detailed Description
Readily available over-the-counter (OTC) medication for symptomatic relief and appropriate oral hydration can be health saving measures of great convenience for those affected by enteric bacterial and...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04811339
Start Date
October 27 2020
End Date
August 15 2021
Last Update
March 1 2023
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202