Status:
UNKNOWN
Vocal Feature Analysis Algorithm for COVID-19 Detection
Lead Sponsor:
Soniphi LLC
Collaborating Sponsors:
UserWise, LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtain...
Detailed Description
The primary objective of this observational study is to determine if the Vocal Feature Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from voice recordings. Patien...
Eligibility Criteria
Inclusion
- Male or female, aged \> 18 years
- Provide a valid electronic informed consent form
- Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample.
- Stated willingness to provide evidence of their lab test results
- Pregnant or lactating women may participate
Exclusion
- Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.
- Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery
- Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords
- Treatment with another investigational drug or device within 30 days prior to signing Consent Form
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04418544
Start Date
June 1 2020
End Date
December 1 2020
Last Update
October 30 2020
Active Locations (1)
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1
Soniphi
Sebastopol, California, United States, 95472