Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060722) titled 'MASTARD-COVID: A Matched-Cohort Study of Treatment-requiring Autoimmune Rheumatic Diseases after COVID-19 Using Japanese Health Insurance Claims Data' on Feb. 21.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Coronavirus disease 2019
autoimmune inflammatory rheumatic diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Using the Japan Medical Data Center (JMDC) claims database derived from health insurance union-originated medical databases, COVID-19-infected and uninfected individuals were perfectly matched on a 1:1 basis based on adjustment factors. This study investigates the differential risk of developing AIIRD (Autoimmune Inflammatory Rheumatic Diseases) requiring disease-specific treatment.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The study period spans from January 1, 2020, to August 31, 2022. We identified patients diagnosed with COVID-19, which is categorized under the International Classification of Diseases, Tenth Revision (ICD-10), as U07.1 (COVID-19, virus identified) and U07.2 (COVID-19, virus not identified). These groups form the basis of our exposed cohort. To establish a control group, we selected individuals from the same dataset who were neither diagnosed with COVID-19 nor with B34.2 (unspecified viral infection), matching them with the exposed group based on relevant criteria.
The exposed group (COVID-19 patients) includes individuals with a confirmed diagnosis coded either as U07.1 or U07.2 during the data period. Conversely, the control group (non-COVID-19 patients) consists of individuals who were not diagnosed with COVID-19 or B34.2 within the same timeframe. Additionally, the analysis will differentiate between groups based on the timing of COVID-19 infection, providing insights into the impact of infection waves and potentially differing strains of the virus.
Key exclusion criteria - Patients with AIIRD (Autoimmune/Inflammatory Rheumatic Diseases) diagnoses within the 6 months preceding COVID-19 infection will be excluded from the evaluation.
Target Size - 580000
Recruitment Status:
Recruitment status - Main results already published
Date of protocol fixation - 2024 Year 04 Month 09 Day
Date of IRB - 2024 Year 04 Month 09 Day
Anticipated trial start date - 2024 Year 04 Month 09 Day
Last follow-up date - 2024 Year 04 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061886
Disclaimer: Curated by HT Syndication.
