An observational study in IgG4 Related Disease and Covid19, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 124 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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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.
The diagnosis of IgG4 related disease was made either by:
Exclusion Criteria:
IgG4 patients with pancreatobiliary involvement
Other: exposure to COVID19
Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19
Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement
Incidence of COVID-19 in IgG4 patients with pancreatobiliary involvement
Time frame: Jan to Nov 2020
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Jan to Nov 2020
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong