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

Impact of COVID-19 on the Clinical Outcomes and Management of IgG4 Related Disease Patients With Pancreatobiliary Involvement: a Multicenter Retrospective Study

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source Chinese University of Hong Kong
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.

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.

Overall Status Recruiting
Start Date 2021-03-24
Completion Date 2021-10-01
Primary Completion Date 2021-07-01
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement Jan to Nov 2020
Secondary Outcome
Measure Time Frame
Incidence of severe COVID-19 in IgG4 patients with pancreatobiliary involvement Jan to Nov 2020
Medications for the underlying IgG4 disease used when patient was diagnosed to have COVID-19 Jan to Nov 2020
Risk factors associated with COVID-19 infection in IgG4 patients with pancreatobiliary involvement Jan to Nov 2020
Incidence of postponement or discontinuation of indicated medical treatment for the underlying IgG4 disease during COVID-19 outbreak Jan to Nov 2020
Enrollment 150
Condition
Intervention

Intervention Type: Other

Intervention Name: exposure to COVID19

Description: Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19

Arm Group Label: IgG4 pancreatobiliary

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Raymond Tang, MD Principal Investigator Chinese University of Hong Kong
Overall Contact

Last Name: Raymond Tang, MD

Phone: (852) 35052920

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Prince of Wales Hospital, The Chinese University of Hong Kong Thomas Lam, BS 852-3505-3509 [email protected] Raymond S Tang, MD Principal Investigator
Location Countries

Hong Kong

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: Raymond Shing Yan Tang

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: IgG4 pancreatobiliary

Description: IgG4 patients with pancreatobiliary involvement

Acronym IgG4-COVID
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

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