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Impact of COVID-19 on the Clinical Outcomes and Management of IgG4 Related Disease Patients (IgG4-COVID)

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ClinicalTrials.gov Identifier: NCT04817553
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Raymond Shing Yan Tang, Chinese University of Hong Kong

Study Description
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Brief Summary:
Since December 2019, coronavirus disease 2019 (COVID-19), caused by the severe respiratory syndrome coronavirus 2 (SARS-CoV-2), has affected more than 124 million people worldwide as of 23/3/2021. While studies on the outcomes of inflammatory bowel disease (IBD) (an important gastroenterological disease requiring immunosuppressive therapies for treatment) patients with COVID-19 have been published recently, little is known about the impact of COVID-19 on the clinical outcomes and management of IgG4 related disease patients with pancreatobiliary involvement. Because the number of IgG4 patients with pancreatobiliary involvement cared by individual centers and the prevalence of COVID-19 infection in different geographical regions vary, we propose to conduct a multicenter retrospective study to further evaluate the impact of COVID-19 on the clinical outcomes and management of IgG4 related disease patients with pancreatobiliary involvement.

Condition or disease Intervention/treatment
IgG4 Related Disease Covid19 Other: exposure to COVID19

Detailed Description:

Since December 2019, coronavirus disease 2019 (COVID-19), caused by the severe respiratory syndrome coronavirus 2 (SARS-CoV-2), has affected more than 124 million people worldwide as of 23/3/2021. While many COVID-19 patients have been reported to have a milder clinical course, old age and comorbidities including cardiovascular disease, chronic lung conditions, obesity, and diabetes have been associated with a more severe disease course and higher mortality. Moreover, patients with chronic immune-mediated inflammatory diseases are at risk of viral infections either related to their underlying immune dysfunction or the immunosuppressive therapy that they receive for the chronic inflammatory conditions.

IgG4 related disease is an increasingly recognized immune-mediated condition that may resemble many malignant, infectious or inflammatory diseases. It is characterized by tumor-like lesions, with histopathological features of lymphoplasmacytic infiltrate rich in IgG4-positive plasma cells, obliterative phlebitis, storiform fibrosis, and, often but not always, elevated serum IgG4 concentrations.

While studies on the outcomes of inflammatory bowel disease (IBD) (an important gastroenterological disease requiring immunosuppressive therapies for treatment) patients with COVID-19 have been published recently, little is known about the impact of COVID-19 on the clinical outcomes and management of IgG4 related disease patients with pancreatobiliary involvement. Because the number of IgG4 patients with pancreatobiliary involvement cared by individual centers and the prevalence of COVID-19 infection in different geographical regions vary, we propose to conduct a multicenter retrospective study to further evaluate the impact of COVID-19 on the clinical outcomes and management of IgG4 related disease patients with pancreatobiliary involvement.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of COVID-19 on the Clinical Outcomes and Management of IgG4 Related Disease Patients With Pancreatobiliary Involvement: a Multicenter Retrospective Study
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
IgG4 pancreatobiliary
IgG4 patients with pancreatobiliary involvement
 Other: exposure to COVID19
Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement [ Time Frame: Jan to Nov 2020 ]
    Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement


Secondary Outcome Measures :
  1. Incidence of severe COVID-19 in IgG4 patients with pancreatobiliary involvement [ Time Frame: Jan to Nov 2020 ]
    Incidence of severe COVID-19 in IgG4 patients with pancreatobiliary involvement (defined by the need of ICU admission, ventilator support, or death from COVID-19)

  2. Medications for the underlying IgG4 disease used when patient was diagnosed to have COVID-19 [ Time Frame: Jan to Nov 2020 ]
    Medications such as steroid, steroid-sparing agents, biologics

  3. Risk factors associated with COVID-19 infection in IgG4 patients with pancreatobiliary involvement [ Time Frame: Jan to Nov 2020 ]
    Risk factors include type of medication use, underlying medical conditions (such as diabetes, lung diseases, cardiovascular diseases, liver diseases)

  4. Incidence of postponement or discontinuation of indicated medical treatment for the underlying IgG4 disease during COVID-19 outbreak [ Time Frame: Jan to Nov 2020 ]
    Incidence of postponement or discontinuation of indicated medical treatment for the underlying IgG4 disease during COVID-19 outbreak


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IgG4 patients with pancreatobiliary system involvement receiving care in the gastroenterology (GI) clinic in the participating centers fulfilling the inclusion criteria listed below and without exclusion criteria would be included in the study.
Criteria

Inclusion Criteria:

  1. Age 18 or above
  2. IgG4 related disease patients with pancreatobiliary involvement receiving care in the GI clinic of the participating centers

  3. The diagnosis of IgG4 related disease was made either by:

    1. an elevated serum IgG4 serology level with typical features of pancreatobiliary involvement on imaging (eg, CT / MRI), and/or endoscopic ultrasound (EUS), and/or endoscopic retrograde cholangiopancreatography (ERCP), or
    2. an elevated serum IgG4 serology level with typical histopathologic features of the disease (eg, lymphoplasmacytic infiltration, obliterative phlebitis, and storiform fibrosis) on surgical pathology (eg, biopsy during surgery or surgical resection specimen) or endoscopic biopsies (eg, EUS guided fine needle biopsy).

Exclusion Criteria:

1) Patients who have an alternative diagnosis (i.e., non-IgG4 disease) despite an elevated serum IgG4 level

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817553


Contacts
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Contact: Raymond Tang, MD (852) 35052920 raymondtang@cuhk.edu.hk
Contact: Thomas Lam, MS (852) 35052920 Thomaslam@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Sha Tin, New Territories, Hong Kong
Contact: Thomas Lam, BS    852-3505-3509    thomaslam@cuhk.edu.hk   
Principal Investigator: Raymond S Tang, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Raymond Tang, MD Chinese University of Hong Kong
More Information
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Publications:

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Responsible Party: Raymond Shing Yan Tang, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04817553    
Other Study ID Numbers: IgG4-COVID
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raymond Shing Yan Tang, Chinese University of Hong Kong:
IgG4
Additional relevant MeSH terms:
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COVID-19
Immunoglobulin G4-Related Disease
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases