Unique ID issued by UMIN | UMIN000051287 |
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Receipt number | R000058475 |
Scientific Title | Association of COVID-19 with the development of autoimmune diseases in Japan; a retrospective cohort study |
Date of disclosure of the study information | 2023/12/01 |
Last modified on | 2023/11/16 16:06:48 |
Association of COVID-19 with the development of autoimmune diseases in Japan
Association of COVID-19 with the development of autoimmune diseases in Japan
Association of COVID-19 with the development of autoimmune diseases in Japan; a retrospective cohort study
Association of COVID-19 with the development of autoimmune diseases in Japan
Japan |
COVID-19
Clinical immunology |
Others
NO
To investigate whether COVID-19 increases the risk of developing autoimmune diseases, we analyzed data from an electronic medical records database in Japan.
Others
This study is an exploratory study that aims to investigate the association between viral infections wand autoimmune diseases.
Exploratory
Pragmatic
Not applicable
The primary outcomes will be the development of the following autoimmune diseases;
Rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disease, systemic sclerosis, Sjogren's syndrome, dermatomyositis/polymyositis, IgG4-related disease, polymyalgia rheumatica, antiphospholipid syndrome, ANCA-associated vasculitis, Hashimoto's thyroiditis, Graves' disease, Behcet's disease, inflammatory bowel disease, psoriasis, and type 1 diabetes.
- The laboratory characteristics at the time of the development of autoimmune diseases.
- The risk of developing autoimmune diseases due to epidemic strains of SARS-CoV-2, such as alpha, delta, and omicron.
- The association between COVID-19 severity and the development of autoimmune diseases.
Observational
Not applicable |
Not applicable |
Male and Female
[COVID-19]
1. Subjects with the first COVID-19 diagnosis from Jan 16, 2020, to Dec 31, 2022. The diagnosis date for COVID-19 is Day 0.
2. Subjects with 180 days of a lookback period and at least one visit between Day -180 and Day -1.
3. Subjects with at least one after Day 0.
[Control]
1. Subjects will be sampled from all patients in the RWD-DB based on visit year-month, age(+-2 years), and sex, with a sampling ratio of up to 1:10. Day 0 for the control subjects will match the corresponding COVID-19 subject's Day 0.
2. Subjects without a diagnosis of COVID-19 on or before Day 0
3. Subjects with 180 days of a lookback period and at least one visit between Day -180 and Day -1.
4. Subjects with at least one after Day 0.
Not applicable
90000
1st name | Shoichiro |
Middle name | |
Last name | Inokuchi |
Real World Data, Co., Ltd.
Research and Analytics
600-8233
Shiseido Kyoto Bld.4F, 480, Aburanokojidori, Kizuyabashi-sagaru, Kitafudondocho, Shimogyo-ku, Kyoto, Kyoto, Japan
+81-75-748-0742
sho_inokuchi1986@yahoo.co.jp
1st name | Shoichiro |
Middle name | |
Last name | Inokuchi |
Real World Data, Co., Ltd.
Research and Analytics
600-8233
Shiseido Kyoto Bld.4F, 480, Aburanokojidori, Kizuyabashi-sagaru, Kitafudondocho, Shimogyo-ku, Kyoto,
+81-75-748-0742
sho_inokuchi1986@yahoo.co.jp
Real World Data, Co., Ltd.
Real World Data, Co., Ltd.
Profit organization
N/A
N/A
N/A
N/A
NO
2023 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2022 | Year | 05 | Month | 02 | Day |
2023 | Year | 05 | Month | 02 | Day |
2023 | Year | 05 | Month | 02 | Day |
This study is a retrospective cohort study using Japanese electronic medical records database.
2023 | Year | 06 | Month | 07 | Day |
2023 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058475
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