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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051287

Enrollment

90000

Registered

2023-12-01

Start date

2023-05-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [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.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
- 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.	—

Countries

Japan

Contacts

Public ContactShoichiro Inokuchi

Real World Data, Co., Ltd. Research and Analytics

sho_inokuchi1986@yahoo.co.jp+81-75-748-0742

Outcome results