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

NCT04769258 | Unknown DMC

• 1 other identifier: IGIBD001
• Study Type: observational
• Target: 1,380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months from the vaccination

Secondary Outcomes (7)

• Rate of COVID-19 occurrence

  12 months from the vaccination

• Rate of adherence to the vaccination

  12 months from the vaccination

• Rate of adverse events of the different vaccines

  12 months from the vaccination

• Rate of IBD flare-ups

  12 months from the vaccination

• Predictors of effectiveness of COVID-19 vaccine

  12 months from the vaccination

Study Arms (2)

Patients with IBD treated with immunomodulatory drugs

Biological: Pfizer Comirnaty vaccine

Patients with IBD not treated with the immunomodulatory drugs

Biological: Pfizer Comirnaty vaccine

Interventions

Pfizer Comirnaty vaccine BIOLOGICAL

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.

Also known as: Moderna (Moderna vaccine, mRNA-1273), Astrazeneca (Oxford-Astrazeneca, ChAdOx1)

Patients with IBD not treated with the immunomodulatory drugs; Patients with IBD treated with immunomodulatory drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Group for the study of Inflammatory Bowel Disease (IG-IBD): lead

Related Publications (2)

• 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.

  PMID: 37115976 DERIVED

• Macaluso 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.

  PMID: 36127228 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

2019-nCoV Vaccine mRNA-1273; ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Vaccines, DNA

Central Study Contacts

Ambrogio Orlando, Director

CONTACT

+390916802022; ambrogiorlando@gmail.com

Fabio Macaluso, Doctor

CONTACT

+390916802022; fsmacaluso@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 24, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02