Trial Outcomes & Findings for The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19 (NCT NCT04327674)

NCT ID: NCT04327674

Last Updated: 2024-06-10

Results Overview

Number of patients on mechanical ventilation.

• Recruitment status: COMPLETED
• Target enrollment: 417 participants
• Primary outcome timeframe: During admission, an average of 1 day
• Results posted on: 2024-06-10

Participant Flow

Participant milestones

Measure	Focused Lung Ultrasound All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection.
Overall Study STARTED	417
Overall Study COMPLETED	398
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Focused Lung Ultrasound All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection.
Overall Study Protocol Violation	19

Baseline Characteristics

The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

Baseline characteristics by cohort

Measure	FLUS n=398 Participants All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection
Age, Continuous	67.8 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	398 Participants n=5 Participants

PRIMARY outcome

Timeframe: During admission, an average of 1 day

Number of patients on mechanical ventilation.

Outcome measures

Measure	FLUS n=398 Participants All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection
Mechanical Ventilation	21 Participants

SECONDARY outcome

Timeframe: During admission, an average of 1 day

Intensive care admissions

Outcome measures

Measure	FLUS n=398 Participants All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection
FLUS Findings and Admission to Intensive Care.	28 Participants

SECONDARY outcome

Timeframe: During admission, an average of 1 day

Positive SAR-CoV-2 PCR-test

Outcome measures

Measure	FLUS n=398 Participants All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection
SAR-CoV-2 PCR-test Result.	227 Participants

Adverse Events

FLUS

Serious events: 398 serious events

Other events: 0 other events

Deaths: 47 deaths

Serious adverse events

Measure	FLUS n=398 participants at risk All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection
Respiratory, thoracic and mediastinal disorders Admission to hospital	100.0% 398/398 • Number of events 398 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Søren Helbo Skaarup

Department of Respiratory Diseases and Allergy. Aarhus University Hospital. Denmark.

Phone: 28911869

Email: soeska@rm.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place