Butterfly - Clinical Performance Study

Completed

Conditions studied: COVID-19, Coronavirus Infections

In brief

This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.

Key facts

Study ID

NCT05800158

Run by

Thermo Fisher Scientific, Inc

People needed

1076

Starts

2023-04-12

Expected to finish

2023-08-10

Last updated by the study team

2023-10-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study:
• Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
• Individuals with at least one of the following COVID-19 symptoms:
• fever or chills
• congestion or runny nose
• headache or fatigue
• muscle or body aches
• b. new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea.
• Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.

You may not qualify if…

• Participants meeting the following criterion will be excluded from the study:
• Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.
• Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours

Where it is running

• KUR Research at Exer Urgent Care - Manhattan Beach — Manhattan Beach, California, United States
• KUR Research at Exer Urgent Care - Redondo Beach — Redondo Beach, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Multi Specialty Research Associates — Lake City, Florida, United States
• D&H National Research Centers — Miami, Florida, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• KUR Research at AFC Urgent Care — The Bronx, New York, United States
• KUR Research at AFC Urgent Care — Easley, South Carolina, United States
• KUR Research at AFC Urgent Care — Powdersville, South Carolina, United States
• ClinSearch — Chattanooga, Tennessee, United States
• KUR Research at CityDoc Urgent Care — McKinney, Texas, United States

Full record on ClinicalTrials.gov

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