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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | COVID-19 participants receiving anticoagulants | ||
| Cohort 2 | COVID-19 participants not receiving anticoagulants |
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| 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 |
| 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 |
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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
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Confirmed COVID-19 patients will be defined as patients who had a diagnosis of COVID-19.Two sub populations will be created based on anticoagulation treatment, and the same outcomes of patient characteristics, treatment patterns and clinical outcomes will be assessed:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Minato-ku | Tokyo | 108-0074 | Japan | ||
| Medical Data Vision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
Severity of COVID-19 |
| Up to 9 months |
| Tokyo |
| Japan |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |