Inflammatory Bowel Disease (IBD) and Covid-19 Infection

NCT04492267 | Unknown

• 1 other identifier: 7930
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

SARS-CoV-2; Inflammatory Bowel Disease; IBD; Crohn's disease; Ulcerative colitis; Immunosuppressant therapy; Biologicals; Severe respiratory disease; intensive care unit; Mechanical ventilation; Death

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18 years

You may qualify if:

• Patient over the age of 18 years
• IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
• Patient agreeing to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Respiration Disorders; Death

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean-Marie REIMUND, MD, PhD

CONTACT

33 3 88 12 74 41; jean-marie.reimund@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90; said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: July 7, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

FR (1)