NCT04399681

Brief Summary

Novel Coronavirus 2019 Disease (COVID-19) mortality is highly associated with viral pneumonia and its complications. Accurate and prompt diagnosis shown to be effective to improve outcome by providing early treatment strategies. While chest X-ray (CXR) and computerized tomography (CT) are defined as gold standard, given the advantage of being an ionized radiation free, practical technique point of care ultrasound (POCUS) is also reported as a diagnostic tool for COVID-19. There are limited studies regarding the importance of POCUS in diagnosis and review of COVID-19. Therefore the aim of this study is to evaluate the utility of bedside lung ultrasound on diagnosis of COVID-19 for patients admitted to emergency department .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 10, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 21, 2020

Last Update Submit

May 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of viral pneumonia caused by COVID 19

    Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19

    3 months

Study Arms (1)

Suspected COVID-19 Group

OTHER

Patients who admitted to emergency department with suspicion of COVID 19 pneumonia will be evaluated with POCUS/ bedside lung ultrasound.

Device: Bedside lung ultrasound

Interventions

Point of care ultrasound will be used as bedside lung ultrasound to determine the patients if they have a COVID-19 pneumonia.

Suspected COVID-19 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with an informed consent
  • Admission to emergency department with symptoms or signs of COVID-19

You may not qualify if:

  • Absence of informed consent
  • Patients under age of 18
  • Presence of acute coronary syndrome
  • Presence of chronic lung disease
  • Pregnancy
  • Presence of trauma
  • Patients with a diagnosis of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 22, 2020

Study Start

May 10, 2020

Primary Completion

August 10, 2020

Study Completion

September 10, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations