Effectiveness and Safety of COVID-19 Vaccine in Patients With IBD Treated With Immunomodulatory or Biological Drugs (ESCAPE-IBD) (ESCAPE-IBD)

February 23, 2021 updated by: Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

690 patients with IBD treated with immunomodulatory drugs (cases) and 690 patients with IBD not treated withimmunomodulatory drugs (controls)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with IBD treated with immunomodulatory drugs
Biological: Pfizer Comirnaty vaccine
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.
Other Names:
  • Moderna (Moderna vaccine, mRNA-1273)
  • Astrazeneca (Oxford-Astrazeneca, ChAdOx1)
Patients with IBD not treated with the immunomodulatory drugs
Biological: Pfizer Comirnaty vaccine
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.
Other Names:
  • Moderna (Moderna vaccine, mRNA-1273)
  • Astrazeneca (Oxford-Astrazeneca, ChAdOx1)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
12 months from the vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of COVID-19 occurrence
Time Frame: 12 months from the vaccination
To assess the rate of COVID-19 occurrence over a temporal end-point of one year from the last dose of the vaccination
12 months from the vaccination
Rate of adherence to the vaccination
Time Frame: 12 months from the vaccination
To assess the rate of adherence to the vaccination by identifying the patients not willing to be vaccinated during screening
12 months from the vaccination
Rate of adverse events of the different vaccines
Time Frame: 12 months from the vaccination
To assess the rate of adverse events of the different vaccines
12 months from the vaccination
Rate of IBD flare-ups
Time Frame: 12 months from the vaccination
To assess the rate of IBD flare-ups occurring within 3 months from the last dose of vaccine to those occurring thereafter
12 months from the vaccination
Predictors of effectiveness of COVID-19 vaccine
Time Frame: 12 months from the vaccination
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).
12 months from the vaccination
Differences of effectiveness between patients
Time Frame: 12 months from the vaccination
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).
12 months from the vaccination
Differences of effectiveness between the several vaccines
Time Frame: 12 months from the vaccination
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).
12 months from the vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IGIBD001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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