TREATMENT WITH BISMUTE SUBCITRATE IN FRAGILE PATIENTS WITH SARS-CoV-2 INFECTION AND DIARRHEA NOT FITTING FOR TRANSFER TO ACUTE HOSPITAL (COVID-19) (COVID-19 BISMUTE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A07) ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

  ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
• Medical condition to be studied:
  COVID-19 treatment

Population studied

• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  32

Study design details

• Main study objective:
  To determine the efficacy of bismuth subcitrate in the treatment of diarrhea as the main symptom of COVID 19 disease, in the group of fragile patients with associated comorbidities and not candidates for invasive therapy or acute hospital referral.
• Data analysis plan:
  Main endpoint: To determine the efficacy of bismuth colloidal compounds in fragile and pluripathological patients, with diagnosis of VIDOC19 and presence of diarrhea. The number of diarrheal stools per day and the number of days with stools will be analyzed.Secondary endpoint: To analyze if the concomitant pathology influences the evolution of the patient, through the calculation of the Charlson Index.Analysis of the results: Quantitative variables will be described by means and standard deviation (if they follow a normal distribution) or by median and range. Qualitative variables will be described by percentages and 95% confidence intervals.