Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04769258 |
| Other study ID # |
IGIBD001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) |
| Contact |
Ambrogio Orlando, Director |
| Phone |
+390916802022 |
| Email |
ambrogiorlando[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The COVID-19 pandemic has led to initial concerns for patients with Inflammatory Bowel
Disease treated with immunosuppressive drugs, as they could be theoretically exposed to a
higher risk of SARS-CoV-2 infection and/or severe forms of COVID-19.
Although initial studies have not shown an increased risk of developing SARS-CoV-2 disease
related to immunosuppressive therapy, robust data are not yet available to allow for risk
stratification. In this regard, the availability of vaccines represents a cornerstone in the
management of the pandemic. Unfortunately, patients on immunosuppressive drugs have largely
been excluded from the trials of COVID-19 vaccines, creating potential concerns regarding the
validity of their efficacy for IBD patients treated with immunosuppressive agents.
Description:
This is a 12-month, prospective, multicentre, case-control, observational study comparing
effectiveness and safety of COVID-19 vaccine in patients with IBD treated with
immunomodulatory drugs (cases) compared with those not treated with the aforementioned drugs
(controls). The study should be regarded as observational because the participants will
receive the intervention (Covid-19 Vaccine) as part of routine medical care (the
administration will be performed outside the study and according to the times and modalities
established by the Italian National Vaccination for the whole Italian population aged 18 and
over). Then, we aim to assess the effect of this intervention in two predefined groups of
individuals (cases and controls). All consecutive patients admitted at each IG-IBD centre
that agree to participate in this study could be screened for inclusion. In case of patient's
refusal to COVID-19 vaccination, this will be recorded in order to estimate the rate of
adherence to the vaccination. Similarly, patients willing to vaccinate but unable to
participate in the study due to logistic problems (for example; long distance from the IBD
centre) will be recorded.
After enrollment, each patient will be visited at baseline; the interval between basal visit
and the subsequent vaccine shall not exceed 10 days. The vaccine will be administered to the
patients according to the times and modalities established by the Italian National
Vaccination Plan. After the last dose of the vaccine, each patient will enter a 12 month
follow-up period. An additional follow-up period will be admitted, as required by clinicians,
in order to further evaluate ongoing adverse events.
At baseline, all enrolled patients will undergo a detailed assessment including:
demographics, smoking status, body mass index, co-morbidities (presence of diabetes, arterial
hypertension, chronic obstructive pulmonary disease, heart disease, and so on),
stratification of the disease according to the Montreal classification, activity of the
disease (assessed with Harvey-Bradshaw Index for CD, and Partial Mayo Score for UC), current
medications, laboratory parameters (haemoglobin, white blood cells, C-reactive protein,
faecal calprotectin). Furthermore, all enrolled patients will be tested for the quantitative
detection of IgM and IgG antibodies against SARS-CoV-2. In case of IgM positivity, patients
will be invited to perform a nasopharyngeal swab for the detection of SARS-CoV-2 RNA. The
safety of the vaccine will be assessed by considering the incidence of reported adverse
events, which will be reported by the patients during the 10 days following the
administration of the vaccine (single assessment in case of single-dose vaccine, double
assessment in case of double-dose vaccines, i.e. one evaluation for each dose). After 2 and
12 months from the last dose of the vaccination, the quantitative detection of IgM/IgG
antibodies against SARS-CoV-2 will be repeated. The dosage of antibodies will be centrally
performed at IEO in Milan. In addition, a proactive surveillance will be performed at 3,6,
and 12 months - preferably combined with pre-scheduled direct visits, or alternatively via
remote contacts - to detect new or suspected diagnosis of COVID-19. In case of active
symptoms suspected for COVID-19 without an established diagnosis, patients will be invited to
perform a nasopharyngeal swab for the detection of SARS-CoV-2 RNA. The proactive surveillance
will also involve the occurrence of adverse events to the vaccine and the assessment of
disease activity to detect flare-ups of IBD (see timeline).
All data will be collected anonymously in a specifically arranged eCRF form inside the IG-IBD
registry.
