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

Covid19 Clinical Trial

— IgG4-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817553
• Other study ID #: IgG4-COVID
• Status: Completed
• Start date: March 24, 2021
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• IgG4 Related Disease

Intervention

Other:
• exposure to COVID19
Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, The Chinese University of Hong Kong	Sha Tin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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