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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; IgG4 Related Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Sha Tin, New Territories, Hong Kong
      • Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement	Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement	Jan to Nov 2020

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• Kamisawa T, Zen Y, Pillai S, Stone JH. IgG4-related disease. Lancet. 2015 Apr 11;385(9976):1460-71. doi: 10.1016/S0140-6736(14)60720-0. Epub 2014 Dec 4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2021
• Primary Completion (ACTUAL): January 10, 2023
• Study Completion (ACTUAL): January 10, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: IgG4
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Immunoglobulin G4-Related Disease
• Other Study ID Numbers: IgG4-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No