A Study of Anticoagulation Treatment Patterns and Outcomes of Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) in Japan

Study Overview
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Brief Summary
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The purpose of this study is to describe demographic and clinical characteristics of participants who are hospitalized due to coronavirus 2019 (COVID-19), treatment use for COVID-19 and COVID-19 symptoms, and composite outcomes of COVID-19. This study will also compare composite outcomes between COVID-19 participants treated with and without anticoagulant therapy during follow-up period.

Official Title
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Real-World Evidence for Anticoagulation Treatment Patterns and Outcomes of Patients Hospitalized With COVID-19 in Japan - A Database Study

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • At least one diagnosis code for COVID-19 (International Classification of Diseases (ICD)-10: U07.1 or B34.2) during hospitalization Exclusion Criteria: • None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>COVID-19 participants receiving anticoagulants | |
| Cohort 2<br>COVID-19 participants not receiving anticoagulants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age group |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Height |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Weight |  | At Baseline | 
| Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Body Mass Index (BMI) |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Treatments |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Comorbidities |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Follow-up |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: History of thrombosis |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Charlson Comorbidity Index (CCI) |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: CCI severity |  | At Baseline | 
| Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Molecular/diagnosis testing |  | At Baseline | 
| Distribution of the use of treatments for COVID-19: Anticoagulation |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: Angiotensin-converting enzyme (ACE) inhibitors |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: Angiotensin II receptor blockers (ARBs) |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: ARBs combination |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: Statin |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: HIV protease inhibitor |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19: Non-pharmacological treatment |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: Anticoagulation |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: Angiotensin-converting enzyme (ACE) inhibitors |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: Angiotensin II receptor blockers (ARBs) |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: ARBs combinations |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: Statin |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: HIV protease inhibitor |  | Up to 9 months | 
| Distribution of the use of treatments for COVID-19 symptoms: Non-pharmacological treatment |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: In-hospital death |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: Overall survival |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: Utilization of Extracorporeal membrane oxygenation (ECMO) |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: Utilization of mechanical ventilation (invasive & noninvasive) |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: Utilization of oxygen therapy |  | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients: Intensive care unit/high care unit (ICU/HCU) admission |  | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of composite outcomes of COVID-19 patients treated with anticoagulant therapy during the follow-up period | Severity of COVID-19 | Up to 9 months | 
| Distribution of composite outcomes of COVID-19 patients treated without anticoagulant therapy during the follow-up period | Severity of COVID-19 | Up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulant, Apixaban, BMS-562247, Coronavirus disease 2019, COVID-19