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COVID-19NCT04828772

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

An observational study of COVID-19, run by Bristol-Myers Squibb at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19
How many people
9,282 participants
Where
2 sitesJapan
Study dates
17 Aug 2020to 7 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • At least one diagnosis code for COVID-19 (International Classification of Diseases (ICD)-10: U07.1 or B34.2) during hospitalization

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Local Institution

    Minato-ku, Tokyo, 108-0074

  • Medical Data Vision

    Tokyo

Other trials in Japan

About this study

Official title: 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.

Conditions
COVID-19
Keywords
Anticoagulant, Apixaban, BMS-562247, Coronavirus disease 2019, COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04828772
Study groupRoleWhat they receive
Cohort 1COVID-19 participants receiving anticoagulants
Cohort 2COVID-19 participants not receiving anticoagulants

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: At Baseline

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

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

    Measured: Up to 9 months

Secondary outcomes (2)

  1. Distribution of composite outcomes of COVID-19 patients treated with anticoagulant therapy during the follow-up period

    Severity of COVID-19

    Measured: Up to 9 months

  2. Distribution of composite outcomes of COVID-19 patients treated without anticoagulant therapy during the follow-up period

    Severity of COVID-19

    Measured: Up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start17 Aug 2020
  3. Primary completion31 Jan 2021
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
9,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04828772
Sponsor's protocol ID
CV185-801
Status last verified
May 2022
First submitted
25 Mar 2021
Last updated
12 May 2022
Results posted
No

Publications

  • 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

    PubMed 35244208

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Bristol-Myers Squibb at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of socio-demographic characteristics of COVID-19 patients who are hospitalized from COVID-19: Age (time frame: At Baseline). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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