A Study of Anticoagulation Treatment Patterns and Outcomes of Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) in Japan
Completed
- Conditions
- COVID-19
- Registration Number
- NCT04828772
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9282
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender At Baseline Distribution of composite outcomes of COVID-19 patients: Overall survival Up to 9 months Distribution of the use of treatments for COVID-19: HIV protease inhibitor Up to 9 months Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Treatments At Baseline Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month At Baseline Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Follow-up At Baseline Distribution of the use of treatments for COVID-19: ARBs combination 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: 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: Non-pharmacological treatment Up to 9 months Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Comorbidities 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 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: Statin Up to 9 months Distribution of the use of treatments for COVID-19 symptoms: ARBs combinations 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: Intensive care unit/high care unit (ICU/HCU) admission Up to 9 months 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: Height At Baseline Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Weight 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 the use of treatments for COVID-19: Anticoagulation Up to 9 months Distribution of the use of treatments for COVID-19: Angiotensin II receptor blockers (ARBs) Up to 9 months Distribution of composite outcomes of COVID-19 patients: In-hospital death Up to 9 months 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 symptoms: Anticoagulation Up to 9 months Distribution of the use of treatments for COVID-19 symptoms: HIV protease inhibitor 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 oxygen therapy Up to 9 months Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: History of thrombosis At Baseline Distribution of the use of treatments for COVID-19 symptoms: Statin Up to 9 months
- Secondary Outcome Measures
Name Time Method Distribution of composite outcomes of COVID-19 patients treated with anticoagulant therapy during the follow-up period Up to 9 months Severity of COVID-19
Distribution of composite outcomes of COVID-19 patients treated without anticoagulant therapy during the follow-up period Up to 9 months Severity of COVID-19
Trial Locations
- Locations (2)
Medical Data Vision
🇯🇵Tokyo, Japan
Local Institution
🇯🇵Minato-ku, Tokyo, Japan