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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04828772

Enrollment

9282

Registered

2021-04-02

Start date

2020-08-17

Completion date

2022-02-07

Last updated

2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Anticoagulant, Apixaban, BMS-562247, Coronavirus disease 2019, COVID-19

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Distribution of composite outcomes of COVID-19 patients: Intensive care unit/high care unit (ICU/HCU) admission	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: In-hospital death	Up to 9 months
Distribution of composite outcomes of COVID-19 patients: Overall survival	Up to 9 months
Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month	At Baseline
Distribution of the use of treatments for COVID-19 symptoms: Non-pharmacological treatment	Up to 9 months
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: 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 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	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 composite outcomes of COVID-19 patients: Utilization of Extracorporeal membrane oxygenation (ECMO)	Up to 9 months

Secondary

Measure	Time frame	Description
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
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

Countries

Japan

Outcome results