NCT04352842

Brief Summary

The cardiovascular effects of coronavirus disease 2019 (COVID-19) are not yet fully known. We conducted a prospective and dynamic echocardiographic study to investigate the cardiac structural and functional changes in COVID-19 patients in intensive care unit (ICU).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 21, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

May 19, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 16, 2020

Last Update Submit

May 17, 2020

Conditions

Covid19Echocardiography

Keywords

COVID-19Echocardiographycardiac structurecardiac function

Outcome Measures

Primary Outcomes (1)

  • Death

    Death of any cause

    From admission to April 8 2020 (cutoff day)

Study Arms (2)

Non-survivors

Patients deceased during the study period

Other: Echocardiography

Survivors

Patients survived during the study period

Other: Echocardiography

Interventions

EchocardiographyOTHER

An expert with 17-year professional experience performed all the echocardiography examinations using a GE LOGIQTM e portable color ultrasound diagnostic machine (GE Healthcare, WI, USA) that was specially used in the contaminated area. Two-dimensional and Doppler echocardiographic measurements were conducted following the recommendations of the American Society of Echocardiography

Non-survivorsSurvivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted in an intensive care unit (ICU) during February 22 to April 3, 2019 in a special hospital for COVID-19 patients in Wuhan, China

You may qualify if:

  • Patients had been diagnosed of COVID-19 according to the criteria established by the WHO interim guidance and admitted to ICU because of severe or critical condition

You may not qualify if:

  • Patients who were \< 18 years and whose entire stay in hospital lasted for \< 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jun Pu, M.D

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

January 21, 2020

Primary Completion

April 8, 2020

Study Completion

April 8, 2020

Last Updated

May 19, 2020

Record last verified: 2020-04

Locations

CN(1)