Inflammatory Bowel Disease (IBD) and Covid-19 Infection

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT04492267
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2021-01-07
• Study Completion: 2021-01-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg; 🇫🇷 Strasbourg, France