Clinical trial NCT04828772: A Study of Anticoagulation Treatment Patterns and Outcomes of Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) in Japan
Official title: Real-World Evidence for Anticoagulation Treatment Patterns and Outcomes of Patients Hospitalized With COVID-19 in Japan - A Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Anticoagulant
Apixaban
BMS-562247
Coronavirus disease 2019
COVID-19
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 9282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age group
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Height
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Weight
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Body Mass Index (BMI)
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Treatments
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Comorbidities
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Follow-up
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: History of thrombosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Charlson Comorbidity Index (CCI)
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: CCI severity
timeFrame: At Baseline
measure: Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Molecular/diagnosis testing
timeFrame: At Baseline
measure: Distribution of the use of treatments for COVID-19: Anticoagulation
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: Angiotensin-converting enzyme (ACE) inhibitors
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: Angiotensin II receptor blockers (ARBs)
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: ARBs combination
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: Statin
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: HIV protease inhibitor
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19: Non-pharmacological treatment
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: Anticoagulation
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: Angiotensin-converting enzyme (ACE) inhibitors
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: Angiotensin II receptor blockers (ARBs)
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: ARBs combinations
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: Statin
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: HIV protease inhibitor
timeFrame: Up to 9 months
measure: Distribution of the use of treatments for COVID-19 symptoms: Non-pharmacological treatment
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: In-hospital death
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: Overall survival
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: Utilization of Extracorporeal membrane oxygenation (ECMO)
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: Utilization of mechanical ventilation (invasive & noninvasive)
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: Utilization of oxygen therapy
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients: Intensive care unit/high care unit (ICU/HCU) admission
timeFrame: Up to 9 months
Secondary outcomes:
measure: Distribution of composite outcomes of COVID-19 patients treated with anticoagulant therapy during the follow-up period
timeFrame: Up to 9 months
measure: Distribution of composite outcomes of COVID-19 patients treated without anticoagulant therapy during the follow-up period
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Tokyo
country: Japan
facility: Medical Data Vision
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.