Inflammatory Bowel Disease (IBD) and Covid-19 Infection

NCT ID: NCT04492267

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-01-07

Brief Summary

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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

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Marie REIMUND, MD, PhD

Role: CONTACT

33 3 88 12 74 41

Saïd CHAYER, PhD, HDR

Role: CONTACT

33 3 88 11 66 90

Facility Contacts

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Jean-Marie REIMUND, MD, PhD

Role: primary

33 3 88 12 74 41

Other Identifiers

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7930

Identifier Type: -

Identifier Source: org_study_id

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