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

Completed

• Conditions: IgG4 Related Disease; Covid19
• Interventions: Other: exposure to COVID19

• Registration Number: NCT04817553
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IgG4 pancreatobiliary	exposure to COVID19	IgG4 patients with pancreatobiliary involvement

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement	Jan to Nov 2020	Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement

Secondary Outcome Measures

Name	Time	Method
Incidence of severe COVID-19 in IgG4 patients with pancreatobiliary involvement	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)
Incidence of postponement or discontinuation of indicated medical treatment for the underlying IgG4 disease during COVID-19 outbreak	Jan to Nov 2020	Incidence of postponement or discontinuation of indicated medical treatment for the underlying IgG4 disease during COVID-19 outbreak
Medications for the underlying IgG4 disease used when patient was diagnosed to have COVID-19	Jan to Nov 2020	Medications such as steroid, steroid-sparing agents, biologics
Risk factors associated with COVID-19 infection in IgG4 patients with pancreatobiliary involvement	Jan to Nov 2020	Risk factors include type of medication use, underlying medical conditions (such as diabetes, lung diseases, cardiovascular diseases, liver diseases)

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Sha Tin, New Territories, Hong Kong