Real-World Evidence for Anticoagulation Treatment Patterns and Outcomes of Patients Hospitalized With COVID-19 in Japan - A Database Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 9,282
- Locations
- 2
- Primary Endpoint
- Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender
Time Frame: At Baseline
Distribution of composite outcomes of COVID-19 patients: Overall survival
Time Frame: Up to 9 months
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month
Time Frame: At Baseline
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Follow-up
Time Frame: At Baseline
Distribution of the use of treatments for COVID-19: ARBs combination
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19: Non-pharmacological treatment
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: Angiotensin-converting enzyme (ACE) inhibitors
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: Angiotensin II receptor blockers (ARBs)
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: Non-pharmacological treatment
Time Frame: Up to 9 months
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Body Mass Index (BMI)
Time Frame: At Baseline
Distribution of the use of treatments for COVID-19: Angiotensin-converting enzyme (ACE) inhibitors
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19: Statin
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: ARBs combinations
Time Frame: Up to 9 months
Distribution of composite outcomes of COVID-19 patients: Utilization of mechanical ventilation (invasive & noninvasive)
Time Frame: Up to 9 months
Distribution of composite outcomes of COVID-19 patients: Intensive care unit/high care unit (ICU/HCU) admission
Time Frame: Up to 9 months
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age
Time Frame: At Baseline
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age group
Time Frame: At Baseline
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Height
Time Frame: At Baseline
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Weight
Time Frame: At Baseline
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Charlson Comorbidity Index (CCI)
Time Frame: At Baseline
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: CCI severity
Time Frame: At Baseline
Distribution of the use of treatments for COVID-19: Anticoagulation
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19: Angiotensin II receptor blockers (ARBs)
Time Frame: Up to 9 months
Distribution of composite outcomes of COVID-19 patients: In-hospital death
Time Frame: Up to 9 months
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Treatments
Time Frame: At Baseline
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Comorbidities
Time Frame: At Baseline
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Molecular/diagnosis testing
Time Frame: At Baseline
Distribution of the use of treatments for COVID-19 symptoms: Anticoagulation
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: HIV protease inhibitor
Time Frame: Up to 9 months
Distribution of composite outcomes of COVID-19 patients: Utilization of Extracorporeal membrane oxygenation (ECMO)
Time Frame: Up to 9 months
Distribution of composite outcomes of COVID-19 patients: Utilization of oxygen therapy
Time Frame: Up to 9 months
Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: History of thrombosis
Time Frame: At Baseline
Distribution of the use of treatments for COVID-19: HIV protease inhibitor
Time Frame: Up to 9 months
Distribution of the use of treatments for COVID-19 symptoms: Statin
Time Frame: Up to 9 months
Secondary Outcomes
- Distribution of composite outcomes of COVID-19 patients treated with anticoagulant therapy during the follow-up period(Up to 9 months)
- Distribution of composite outcomes of COVID-19 patients treated without anticoagulant therapy during the follow-up period(Up to 9 months)