Inflammatory Bowel Disease (IBD) and Covid-19 Infection

Inflammatory Bowel Disease Clinical Trial

— MICI-Covid-19  

Official title:

SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492267
• Other study ID #: 7930
• Status: Recruiting
• Start date: July 7, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: July 2020
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Marie REIMUND, MD, PhD
• Phone: 33 3 88 12 74 41
• Email: jean-marie.reimund[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over the age of 18 years

• IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)

• Patient agreeing to participate in the study

Exclusion Criteria:

• Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier

• Patient under guardianship or trusteeship

• Patient under safeguard of justice

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
France	Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients		Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined