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Completed

NCT Number: NCT04828772

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Minato-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age

    Time frame: At Baseline

  2. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age group

    Time frame: At Baseline

  3. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Gender

    Time frame: At Baseline

  4. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Index month

    Time frame: At Baseline

  5. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Height

    Time frame: At Baseline

  6. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Weight

    Time frame: At Baseline

  7. Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Body Mass Index (BMI)

    Time frame: At Baseline

  8. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Treatments

    Time frame: At Baseline

  9. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Comorbidities

    Time frame: At Baseline

  10. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Follow-up

    Time frame: At Baseline

  11. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: History of thrombosis

    Time frame: At Baseline

  12. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Charlson Comorbidity Index (CCI)

    Time frame: At Baseline

  13. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: CCI severity

    Time frame: At Baseline

  14. Distribution of clinical characteristics of COVID-19 patients who are hospitalized from COVID-19: Molecular/diagnosis testing

    Time frame: At Baseline

  15. Distribution of the use of treatments for COVID-19: Anticoagulation

    Time frame: Up to 9 months

  16. Distribution of the use of treatments for COVID-19: Angiotensin-converting enzyme (ACE) inhibitors

    Time frame: Up to 9 months

  17. Distribution of the use of treatments for COVID-19: Angiotensin II receptor blockers (ARBs)

    Time frame: Up to 9 months

  18. Distribution of the use of treatments for COVID-19: ARBs combination

    Time frame: Up to 9 months

  19. Distribution of the use of treatments for COVID-19: Statin

    Time frame: Up to 9 months

  20. Distribution of the use of treatments for COVID-19: HIV protease inhibitor

    Time frame: Up to 9 months

  21. Distribution of the use of treatments for COVID-19: Non-pharmacological treatment

    Time frame: Up to 9 months

  22. Distribution of the use of treatments for COVID-19 symptoms: Anticoagulation

    Time frame: Up to 9 months

  23. Distribution of the use of treatments for COVID-19 symptoms: Angiotensin-converting enzyme (ACE) inhibitors

    Time frame: Up to 9 months

  24. Distribution of the use of treatments for COVID-19 symptoms: Angiotensin II receptor blockers (ARBs)

    Time frame: Up to 9 months

  25. Distribution of the use of treatments for COVID-19 symptoms: ARBs combinations

    Time frame: Up to 9 months

  26. Distribution of the use of treatments for COVID-19 symptoms: Statin

    Time frame: Up to 9 months

  27. Distribution of the use of treatments for COVID-19 symptoms: HIV protease inhibitor

    Time frame: Up to 9 months

  28. Distribution of the use of treatments for COVID-19 symptoms: Non-pharmacological treatment

    Time frame: Up to 9 months

  29. Distribution of composite outcomes of COVID-19 patients: In-hospital death

    Time frame: Up to 9 months

  30. Distribution of composite outcomes of COVID-19 patients: Overall survival

    Time frame: Up to 9 months

  31. Distribution of composite outcomes of COVID-19 patients: Utilization of Extracorporeal membrane oxygenation (ECMO)

    Time frame: Up to 9 months

  32. Distribution of composite outcomes of COVID-19 patients: Utilization of mechanical ventilation (invasive & noninvasive)

    Time frame: Up to 9 months

  33. Distribution of composite outcomes of COVID-19 patients: Utilization of oxygen therapy

    Time frame: Up to 9 months

  34. Distribution of composite outcomes of COVID-19 patients: Intensive care unit/high care unit (ICU/HCU) admission

    Time frame: Up to 9 months

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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