Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Condition: Diarrhea; COVID-19
MeSH terms: COVID-19; Diarrhea
Intervention: Bismuth Subsalicylate 262 milligram (mg) Oral Tablet, Chewable; Placebo oral tablet without BSS
Intervention description: Pepto bismol (bismuth subsalicylate); Placebo Tablet made by P & G to contain everything except active ingredient ( BSS)
Intervention MeSH terms: Bismuth; Bismuth subsalicylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label trial of Bismuth subsalicylate (10 patients) followed by a second, placebo controlled study (50 patients) for mild to moderate COVID-19+ patients.
Masking: Single (Outcomes Assessor)
Masking description: Member of research team not involved in patient care.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility 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 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 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 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