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A prospective nationwide COVID-19 healthcare outcomes registry-based cohort study in Japan: ANCHOR study

M. Hibino, A. Shintani, Y. Chihara, R. Fukai, Y. Tamura, Akihiko Iwase, Kiyoaki Uryu, Masayuki Noguchi et al.

Medicine: Case Reports and Study Protocols, 2025

19 participants

Abstract

The coronavirus disease 2019 (COVID-19) pandemic highlighted the need for real-world evidence on treatment effectiveness and postinfection outcomes. In Japan, comprehensive prospective real-world data remain limited, particularly for oral antiviral treatments and post-COVID-19 conditions. This nationwide registry and cohort study aims to prospectively collect data on COVID-19 patients to address this gap and to evaluate treatment effectiveness and outcomes using cohort analyses.

This large-scale, prospective registry-based cohort study will be conducted at acute care hospitals across Japan and will enroll COVID-19 outpatients and inpatients aged ≥ 12 years with symptom onset within 5 days prior to consent. The study will establish a comprehensive COVID-19 registry and will concurrently serve as a cohort study to assess treatment patterns, effectiveness, and clinical outcomes. Outcome measures, broadly defined for the overall study population, will be collected from electronic health records and patient-reported outcomes via an electronic PRO system at baseline, Day 28, and Day 84. Outcomes include patient characteristics, acute-phase and post-infection symptoms, treatment patterns, clinical outcomes (including severe events), healthcare utilization, work productivity and activity impairment, and safety of anti-severe acute respiratory syndrome coronavirus 2 drugs. However, an interim analysis showed lower-than-expected enrollment, which resulted in insufficient statistical…

How strong is the evidence?

Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 19 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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