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

May 9, 2022 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Medical Data Vision
    • Tokyo
      • Minato-ku, Tokyo, Japan, 108-0074
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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:

  • Sub-population 1: COVID-19 patients receiving anticoagulants
  • Sub-population 2: COVID-19 patients not receiving anticoagulants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
COVID-19 participants receiving anticoagulants
Cohort 2
COVID-19 participants not receiving anticoagulants

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

February 7, 2022

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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