Vocal Feature Analysis Algorithm for COVID-19 Detection

• Conditions: COVID-19
• Interventions: Device: Device used to record voice for screening

• Registration Number: NCT04418544
• Lead Sponsor: Soniphi LLC

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 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.

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. 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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Positive	Device used to record voice for screening	Test positive for Covid using swab test.
Control	Device used to record voice for screening	Do not test positive for COVID

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	6 months	compare Sensitivity and Specificity to standard swab test

Trial Locations

Locations (1)

Soniphi; 🇺🇸 Sebastopol, California, United States