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 obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.
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. Patients eligible for the study are those being tested for COVID-19 based
on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab.
No clinical decisions will be based on the recordings. The results of the algorithm analysis
will not be made available to the subjects or their healthcare providers during or after the
study.
Device: Device used to record voice for screening
voice recording
Inclusion Criteria:
1. Male or female, aged > 18 years
2. Provide a valid electronic informed consent form
3. Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and
those providing an evaluable sample.
4. Stated willingness to provide evidence of their lab test results
5. Pregnant or lactating women may participate
Exclusion Criteria:
1. Presence of tracheostomy or past tracheostomy with permanent change to the voice due
complications that involved the vocal cords.
2. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or
esophageal surgery
3. Prior head, neck or throat cancer treated with radical neck dissection and/or
radiation therapy that may influence the vocal cords
4. Treatment with another investigational drug or device within 30 days prior to signing
Consent Form
Soniphi
Sebastopol, California, United States
Investigator: M Sanderson, BS
research@soniphi.com
Stephen Steady, MD
(415) 309-3242
slsteady@vivacitashealthcare.com
Ari Levitt, MD
(206) 731-9172
aril@sonaphi.com
Stephen Steady, MD, Principal Investigator
Soniphi LLC