Inflammatory Bowel Disease (IBD) and Covid-19 Infection

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04492267

Acronym

MICI-Covid-19

Enrollment

700

Registered

2020-07-30

Start date

2020-07-07

Completion date

2021-01-07

Last updated

2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactJean-Marie REIMUND, MD, PhD

jean-marie.reimund@chru-strasbourg.fr33 3 88 12 74 41

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr33 3 88 11 66 90

Outcome results