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 identification

• EU PAS number:
  EUPAS34925
• Study ID:
  34990
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  In the course of the current pandemic caused by the spread and replication of SARS-Cov-2, respiratory symptoms dominate the clinical picture of the disease. However, a significant percentage of patients with COVID-19 infection present with gastrointestinal symptoms, such as anorexia, vomiting, diarrhea and abdominal pain, which are not always associated with respiratory symptoms or clinics. This percentage, according to current medical literature, ranges from 34% to 60%. Our study wants to focus basically on patients whose main symptom is diarrhea and because of their characteristics of fragility and associated comorbidities are not candidates for referral to acute hospital or aggressive therapies. Bismuth colloidal compounds such as bismuth subsalicylate are antidiarrheal drugs whose mechanism of action is combined: on the one hand, it stimulates the absorption of fluids and electrolytes through the intestinal wall by inhibiting the secretion of chloride, and on the other hand, when hydrolyzed to salicylic acid, it inhibits the synthesis of prostaglandins responsible for intestinal inflammation and hypermotility. Its action is anti-secretory and antimicrobial.In the context of the SARS-CoV-2 infection pandemic, a prioritization of the use of health resources is established. This implies that frail, elderly patients with chronic diseases who, in addition, are often admitted to centres with a high incidence of COVID-19, do not have access to mechanical ventilation, and therefore have even higher mortality. Diarrhea is a major problem in these patients so we have designed a prospective study in which the main objective is to determine the efficacy of bismuth subcitrate treatment in COVID-19 patients with acute diarrhea.Main 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
• Study status:
  Planned

Research institutions and networks

Institutions

Hospital Sociosanitario Francolí

Study timelines

Date when funding contract was signed

Planned: 15/04/2020

Actual: 15/04/2020

Study start date

Planned: 04/05/2020

Data analysis start date

Planned: 05/10/2020

Date of interim report, if expected

Planned: 17/12/2020

Date of final study report

Planned: 15/01/2021

Sources of funding

Other

More details on funding

Internal Funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable