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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgG4 pancreatobiliary | IgG4 patients with pancreatobiliary involvement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exposure to COVID19 | Other | Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19 |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
1) Patients who have an alternative diagnosis (i.e., non-IgG4 disease) despite an elevated serum IgG4 level
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Tang, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Shatin | New Territories | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25481618 | Background | 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. |
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| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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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 |
| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |