Status: Planned First registered on: 24/04/2020
Last updated on: 28/04/2020
1. Study identification
EU PAS Register NumberEUPAS34925
Official titleTREATMENT WITH BISMUTE SUBCITRATE IN FRAGILE PATIENTS WITH SARS-CoV-2 INFECTION AND DIARRHEA NOT FITTING FOR TRANSFER TO ACUTE HOSPITAL (COVID-19)
Study title acronymCOVID-19 BISMUTE
Study typeObservational study
Brief description of the studyIn 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
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameHospital Sociosanitario Francolí
Centre locationTarragona. Spain
Details of (Primary) lead investigator
Title Dr
Last name Sopena
First name Eugenia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?10

AEMPS
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/04/202015/04/2020
Start date of data collection04/05/2020
Start date of data analysis05/10/2020
Date of interim report, if expected17/12/2020
Date of final study report15/01/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherInternal Funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Sopena
First name Eugenia
Address line 1C/Joan Pau II, nº2
Address line 2 
Address line 3 
CityTarragona 
Postcode43005 
CountrySpain
Phone number (incl. country code)0034666152101 
Alternative phone number0034977230888 
Fax number (incl. country code) 
Email address essopena.gipss@gencat.cat
Public Enquiries
Title Dr 
Last name Sopena 
First name Eugenia 
Address line 1C/Joan Pau II, nº2 
Address line 2 
Address line 3 
CityTarragona 
Postcode43005 
CountrySpain 
Phone number (incl. country code)0034666152101 
Alternative phone number0034977230888 
Fax number (incl. country code) 
Email address essopena.gipss@gencat.cat 
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