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

NCT04817553 | Completed

• 1 other identifier: IgG4-COVID
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

IgG4 Related Disease; Covid19

Keywords

IgG4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

IgG4 pancreatobiliary

IgG4 patients with pancreatobiliary involvement

Other: exposure to COVID19

Interventions

exposure to COVID19 OTHER

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

IgG4 pancreatobiliary

Eligibility Criteria

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

You may qualify if:

• Age 18 or above
• IgG4 related disease patients with pancreatobiliary involvement receiving care in the GI clinic of the participating centers
• The diagnosis of IgG4 related disease was made either by:
• 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
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 25481618 BACKGROUND

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease; COVID-19

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raymond Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: March 24, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)