Butterfly - Clinical Performance Study
Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622
1 other identifier
observational
1,076
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Shorter than P25 for all trials
11 active sites
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
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2023
CompletedOctober 18, 2023
October 1, 2023
4 months
March 23, 2023
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical performance evaluation of the COVID-19 test
Clinical performance evaluation of the COVID-19 test using a composite comparator approach with upper respiratory specimens to meet PPA and NPA requirements.
Between April 2023 and August 2023
Identification of adverse events
Identify any adverse events or complications associated with the COVID-19 test
Between April 2023 and August 2023
Study Arms (1)
SARS-CoV-2
Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider.
Interventions
A reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.
Eligibility Criteria
The study population will be composed of participants suspected of COVID-19. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
KUR Research at Exer Urgent Care - Manhattan Beach
Manhattan Beach, California, 90266, United States
KUR Research at Exer Urgent Care - Redondo Beach
Redondo Beach, California, 90277, United States
Medical Center for Clinical Research
San Diego, California, 92120, United States
Multi Specialty Research Associates
Lake City, Florida, 32055, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106, United States
KUR Research at AFC Urgent Care
The Bronx, New York, 10465, United States
KUR Research at AFC Urgent Care
Easley, South Carolina, 29640, United States
KUR Research at AFC Urgent Care
Powdersville, South Carolina, 29611, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
KUR Research at CityDoc Urgent Care
McKinney, Texas, 75204, United States
Biospecimen
nasopharyngeal and anterior nasal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 5, 2023
Study Start
April 12, 2023
Primary Completion
August 10, 2023
Study Completion
August 10, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share