NCT04828772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

March 25, 2021

Last Update Submit

May 9, 2022

Conditions

COVID-19

Keywords

AnticoagulantApixabanBMS-562247Coronavirus disease 2019COVID-19

Outcome Measures

Primary Outcomes (34)

  • 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: Gender

    At Baseline

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

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

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

    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: Intensive care unit/high care unit (ICU/HCU) admission

    Up to 9 months

Secondary Outcomes (2)

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

    Up to 9 months

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

    Up to 9 months

Study Arms (2)

Cohort 1

COVID-19 participants receiving anticoagulants

Cohort 2

COVID-19 participants not receiving anticoagulants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Minato-ku, Tokyo, 108-0074, Japan

Location

Medical Data Vision

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 35244208DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 2, 2021

Study Start

August 17, 2020

Primary Completion

January 31, 2021

Study Completion

February 7, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

JP(2)