Covid19 Clinical Trial
— IgG4-COVIDOfficial title:
Impact of COVID-19 on the Clinical Outcomes and Management of IgG4 Related Disease Patients With Pancreatobiliary Involvement: a Multicenter Retrospective Study
NCT number | NCT04817553 |
Other study ID # | IgG4-COVID |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 24, 2021 |
Est. completion date | January 10, 2023 |
Verified date | February 2023 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital, The Chinese University of Hong Kong | Sha Tin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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
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 |
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