Inflammatory Bowel DiseaseMICI-Covid-19NCT04492267
Inflammatory Bowel Disease (IBD) and Covid-19 Infection
An observational study of Inflammatory Bowel Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to 7 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18 years
Who may be able to join
- Patient over the age of 18 years
- IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
- Patient agreeing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg
Strasbourg, 67091
Jean-Marie REIMUND, MD, PhD, 33 3 88 12 74 41, jean-marie.reimund@chru-strasbourg.fr
Jean-Marie REIMUND, MD, PhD
About this study
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
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
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Respiration Disorders, Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients
Measured: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start7 Jul 2020
- Primary completion7 Jan 2021 (estimated)
- Study completion7 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492267
- Sponsor's protocol ID
- 7930
- Acronym
- MICI-Covid-19
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04492267
- Acronym / sponsor ID
- MICI-Covid-19 / 7930
- Conditions
- Inflammatory Bowel Disease
- Keywords
- SARS-CoV-2, Inflammatory Bowel Disease, IBD, Crohn's disease, Ulcerative colitis, Immunosuppressant therapy, Biologicals, Severe respiratory disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 7 Jan 2021 (estimated)
- Study completion
- 7 Jan 2021 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18 years
Key inclusion criteria (3 listed)
- Patient over the age of 18 years
- IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
- Patient agreeing to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients
Time frame: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marie REIMUND, MD, PhD (33 3 88 12 74 41, jean-marie.reimund@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients (time frame: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.