Overview
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.
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. 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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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