UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051287 |
|---|---|
| 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 | 2024/12/06 10:06:44 |
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Basic information
Public title
Association of COVID-19 with the development of autoimmune diseases in Japan
Acronym
Association of COVID-19 with the development of autoimmune diseases in Japan
Scientific Title
Association of COVID-19 with the development of autoimmune diseases in Japan; a retrospective cohort study
Scientific Title:Acronym
Association of COVID-19 with the development of autoimmune diseases in Japan
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether COVID-19 increases the risk of developing autoimmune diseases, we analyzed data from an electronic medical records database in Japan.
Basic objectives2
Others
Basic objectives -Others
This study is an exploratory study that aims to investigate the association between viral infections wand autoimmune diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
- 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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key exclusion criteria
Not applicable
Target sample size
90000
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inokuchi |
Organization
Real World Data, Co., Ltd.
Division name
Research and Analytics
Zip code
600-8233
Address
Shiseido Kyoto Bld.4F, 480, Aburanokojidori, Kizuyabashi-sagaru, Kitafudondocho, Shimogyo-ku, Kyoto, Kyoto, Japan
TEL
+81-75-748-0742
sho_inokuchi1986@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inokuchi |
Organization
Real World Data, Co., Ltd.
Division name
Research and Analytics
Zip code
600-8233
Address
Shiseido Kyoto Bld.4F, 480, Aburanokojidori, Kizuyabashi-sagaru, Kitafudondocho, Shimogyo-ku, Kyoto,
TEL
+81-75-748-0742
Homepage URL
sho_inokuchi1986@yahoo.co.jp
Sponsor or person
Institute
Real World Data, Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Real World Data, Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Undisclosed
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/jclinrheum/fulltext/2024/03000/persistent_risk_of_developing_autoimmune_dis
Number of participants that the trial has enrolled
90855
Results
A total of 90,855 COVID-19 and 459,827 non-COVID-19 patients were included between January 16, 2020, and December 31, 2022. The relative risk of any autoimmune disease was 2.32 (95% confidence interval, 2.08-2.60).
Results date posted
| 2024 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We identified 258,787 patients who received a COVID-19 diagnosis from January 16, 2020, to December 31, 2022, in the RWD-DB. Among them, 90,855 met the eligibility criteria. In addition, as a non-COVID-19 comparison group, we randomly sampled 897,259 patients, including 459,827 eligible patients. The mean age was 61.3 years (standard deviation [SD], 24.1) for the COVID-19 group and 64.7 years (SD, 21.5) for the non-COVID-19 group. Female patients accounted for 51.1% of the COVID-19 group and 50.6% of the non-COVID-19 group.
Participant flow
The population in the COVID-19 group included patients who received a confirmed diagnosis of COVID-19 (ICD-10 [Tenth Revision of the International Statistical Classification of Diseases and Related Health Problems] code U071) between January 16, 2020 (date of the first case of COVID-19 in Japan) and December 31, 2022. The diagnosis date was considered day 0. Patients were required to have medical records available before day -180 and between day -180 and day -1. Patients with 1 or more medical records after day 0 were included in the analysis.
To create a non-COVID-19 group, patients were randomly selected from the entire RWD-DB and matched based on age, sex, and visit year-month. This process was performed at a ratio of 1:10, meaning that for every COVID-19 case, up to 10 patients were sampled in the group. The first visit date within the corresponding month of the year was designated day 0. The patients were required to have no COVID-19 diagnosis before day 0, and medical records were available before day -180 and from day -180 to day -1. Finally, we included patients with 1 or more medical records after day 0.
Adverse events
Not applicable
Outcome measures
The RRs of the autoimmune diseases were investigated using a standardized mortality ratio weighting-based Cox proportional hazards model. The standardized mean difference was well-balanced in the weighted pseudopopulation. The outcome of any autoimmune disease showed a significant risk in the COVID-19 group (RR [95% CI], 2.32 [2.08-2.60]). All the specific autoimmune diseases investigated demonstrated a significantly high risk of developing autoimmune diseases associated with COVID-19. The sensitivity analysis, in which the follow-up period started from day 61, slightly decreased the risk but yielded similar results, confirming the robustness of our findings.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study using Japanese electronic medical records database.
Due to the use of an anonymized, pre-existing database, IRB approval was waived.
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058475
