Inflammatory Bowel DiseasesESCAPE-IBDNCT04769258
Effectiveness and Safety of COVID-19 Vaccine in Patients With IBD Treated With Immunomodulatory or Biological Drugs (ESCAPE-IBD)
An observational study of Inflammatory Bowel Diseases, run by Italian Group for the study of Inflammatory Bowel Disease (IG-IBD).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Pfizer Comirnaty vaccine
- Type of treatment
- Vaccines
- How many people
- 1,380 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Jun 2022
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 690 patients with IBD treated with immunomodulatory drugs (cases) and 690 patients with IBD not treated withimmunomodulatory drugs (controls)
Who may be able to join
- Patients of either sex, without racial restriction, aged 18 years or older, willing to receive the COVID-19 vaccine
- An established diagnosis of Crohn's disease or Ulcerative Colitis or unclassified colitis
- Current treatment with conventional immunosuppressants (steroids, azathioprine, 6-mercaptopurine, methotrexate), biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), or small molecule drugs (tofacitinib): will be included as cases
- Currently off-therapy or treated with mesalamine only: will be included as controls
- Capability to express a written informed consent for COVID-19 vaccination
- Capability to express a written informed consent for the study
Who cannot join
- Primary immunodeficiencies and human immunodeficiency virus infection
- Vaccination against SARS-CoV-2 already performed before enrolment
- Contraindications to COVID-19 vaccine or intolerance to its components
- Documented history of previous occurrence of COVID-19
- Documented history of previous occurrence of asymptomatic SARS-CoV2 infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease Treated With Immunomodulatory or Biological Drugs
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.
Read the detailed 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Pfizer Comirnaty vaccine
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer Comirnaty vaccineBiological
Also called Moderna (Moderna vaccine, mRNA-1273), Astrazeneca (Oxford-Astrazeneca, ChAdOx1)
COVID 19 vaccines administered to the patients according to the times and modalities established by the Italian National Vaccination Plan. Further vaccines will be evaluated if and when they are available in Italy during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD treated with immunomodulatory drugs | Not described Receives: Biological: Pfizer Comirnaty vaccine | |
| Patients with IBD not treated with the immunomodulatory drugs | Not described Receives: Biological: Pfizer Comirnaty vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative serum titer of IgM and IgG against SARS-CoV-2
To evaluate the quantitative serum titer of IgM and IgG against SARS-CoV-2 after 2 and 12 months from the vaccination in patients with IBD treated with conventional immunosuppressants, biologics, or small molecule drugs (cases) compared with IBD patients not treated with the aforementioned drugs (i.e. off-therapy, or treated with mesalamine only - controls).
Measured: 12 months from the vaccination
Secondary outcomes (7)
Rate of COVID-19 occurrence
To assess the rate of COVID-19 occurrence over a temporal end-point of one year from the last dose of the vaccination
Measured: 12 months from the vaccination
Rate of adherence to the vaccination
To assess the rate of adherence to the vaccination by identifying the patients not willing to be vaccinated during screening
Measured: 12 months from the vaccination
Rate of adverse events of the different vaccines
To assess the rate of adverse events of the different vaccines
Measured: 12 months from the vaccination
Rate of IBD flare-ups
To assess the rate of IBD flare-ups occurring within 3 months from the last dose of vaccine to those occurring thereafter
Measured: 12 months from the vaccination
Predictors of effectiveness of COVID-19 vaccine
To assess the predictors of effectiveness of COVID-19 vaccine at baseline.in terms of quantitative serum titer of IgM and IgG against SARS-CoV-2 after 2 and 12 months from the vaccination (primary objective) and of the rate of COVID-19 occurrence over a temporal end-point of one year from the last dose of the vaccination (one of the secondary objectives).
Measured: 12 months from the vaccination
Differences of effectiveness between patients
To detect differences of effectiveness between patients treated with different immunomodulators.in terms of quantitative serum titer of IgM and IgG against SARS-CoV-2 after 2 and 12 months from the vaccination (primary objective) and of the rate of COVID-19 occurrence over a temporal end-point of one year from the last dose of the vaccination (one of the secondary objectives).
Measured: 12 months from the vaccination
Differences of effectiveness between the several vaccines
To detect differences of effectiveness between the several vaccines that will be available.in terms of quantitative serum titer of IgM and IgG against SARS-CoV-2 after 2 and 12 months from the vaccination (primary objective) and of the rate of COVID-19 occurrence over a temporal end-point of one year from the last dose of the vaccination (one of the secondary objectives).
Measured: 12 months from the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 1,380 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769258
- Sponsor's protocol ID
- IGIBD001
- Acronym
- ESCAPE-IBD
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Principi M, Macaluso FS, Todeschini A, Facciotti F, Contaldo A, Castiglione F, Nardone OM, Spagnuolo R, Doldo P, Riguccio G, Conforti FS, Vigano C, Ascolani M, Fiorino G, Correale C, Bodini G, Milla M, Scardino G, Vernero M, Desideri F, Caprioli F, Mannino M, Rizzo G, Orlando A; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: data of a national study (ESCAPE-IBD). Eur J Gastroenterol Hepatol. 2023 Jun 1;35(6):629-634. doi: 10.1097/MEG.0000000000002550. Epub 2023 Apr 4.
PubMed 37115976Macaluso FS, Principi M, Facciotti F, Contaldo A, Todeschini A, Saibeni S, Bezzio C, Castiglione F, Nardone OM, Spagnuolo R, Fantini MC, Riguccio G, Caprioli F, Vigano C, Felice C, Fiorino G, Correale C, Bodini G, Milla M, Scardino G, Vernero M, Desideri F, Mannino M, Rizzo G, Orlando A; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study. Dig Liver Dis. 2023 Feb;55(2):154-159. doi: 10.1016/j.dld.2022.08.027. Epub 2022 Aug 29.
PubMed 36127228
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease Treated With Immunomodulatory or Biological Drugs
- ClinicalTrials.gov ID
- NCT04769258
- Acronym / sponsor ID
- ESCAPE-IBD / IGIBD001
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)University, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 24 Feb 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD treated with immunomodulatory drugs | – | Biological: Pfizer Comirnaty vaccine |
| Patients with IBD not treated with the immunomodulatory drugs | – | Biological: Pfizer Comirnaty vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 690 patients with IBD treated with immunomodulatory drugs (cases) and 690 patients with IBD not treated withimmunomodulatory drugs (controls)
Key inclusion criteria (6 listed)
- Patients of either sex, without racial restriction, aged 18 years or older, willing to receive the COVID-19 vaccine
- An established diagnosis of Crohn's disease or Ulcerative Colitis or unclassified colitis
- Current treatment with conventional immunosuppressants (steroids, azathioprine, 6-mercaptopurine, methotrexate), biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), or small molecule drugs (tofacitinib): will be included as cases
- Currently off-therapy or treated with mesalamine only: will be included as controls
- Capability to express a written informed consent for COVID-19 vaccination
Key exclusion criteria (5 listed)
- Primary immunodeficiencies and human immunodeficiency virus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pfizer Comirnaty vaccineAlso: Moderna (Moderna vaccine, mRNA-1273), Astrazeneca (Oxford-Astrazeneca, ChAdOx1)COVID 19 vaccines administered to the patients according to the times and modalities established by the Italian National Vaccination Plan. Further vaccines will be evaluated if and when they are available in Italy during the study period. | Biological | Patients with IBD not treated with the immunomodulatory drugs, Patients with IBD treated with immunomodulatory drugs |
Primary outcome
Quantitative serum titer of IgM and IgG against SARS-CoV-2
Time frame: 12 months from the vaccination
To evaluate the quantitative serum titer of IgM and IgG against SARS-CoV-2 after 2 and 12 months from the vaccination in patients with IBD treated with conventional immunosuppressants, biologics, or small molecule drugs (cases) compared with IBD patients not treated with the aforementioned drugs (i.e. off-therapy, or treated with mesalamine only - controls).
7 secondary outcomes
Rate of COVID-19 occurrence
Time frame: 12 months from the vaccination
Rate of adherence to the vaccination
Time frame: 12 months from the vaccination
Rate of adverse events of the different vaccines
Time frame: 12 months from the vaccination
Rate of IBD flare-ups
Time frame: 12 months from the vaccination
Predictors of effectiveness of COVID-19 vaccine
Time frame: 12 months from the vaccination
Differences of effectiveness between patients
Time frame: 12 months from the vaccination
Differences of effectiveness between the several vaccines
Time frame: 12 months from the vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 37115976Principi M, Macaluso FS, Todeschini A, Facciotti F, Contaldo A, Castiglione F, Nardone OM, Spagnuolo R, Doldo P, Riguccio G, Conforti FS, Vigano C, Ascolani M, Fiorino G, Correale C, Bodini G, Milla M, Scardino G, Vernero M, Desideri F, Caprioli F, Mannino M, Rizzo G, Orlando A; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: data of a national study (ESCAPE-IBD). Eur J Gastroenterol Hepatol. 2023 Jun 1;35(6):629-634. doi: 10.1097/MEG.0000000000002550. Epub 2023 Apr 4.
- Derived from this study: PubMed 36127228Macaluso FS, Principi M, Facciotti F, Contaldo A, Todeschini A, Saibeni S, Bezzio C, Castiglione F, Nardone OM, Spagnuolo R, Fantini MC, Riguccio G, Caprioli F, Vigano C, Felice C, Fiorino G, Correale C, Bodini G, Milla M, Scardino G, Vernero M, Desideri F, Mannino M, Rizzo G, Orlando A; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study. Dig Liver Dis. 2023 Feb;55(2):154-159. doi: 10.1016/j.dld.2022.08.027. Epub 2022 Aug 29.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Italian Group for the study of Inflammatory Bowel Disease (IG-IBD).
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 6 inclusion and 5 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Ambrogio Orlando, Director (+390916802022, ambrogiorlando@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative serum titer of IgM and IgG against SARS-CoV-2 (time frame: 12 months from the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769258, which also lists 2 linked publications.
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 24 Feb 2021.