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NCT04828772 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04828772
Other study ID # CV185-801
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2020
Est. completion date February 7, 2022

Study information
Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9282
Est. completion date February 7, 2022
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Local Institution Minato-ku Tokyo
Japan Medical Data Vision Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

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