COVID-19NCT04418544
Vocal Feature Analysis Algorithm for COVID-19 Detection
An observational study of COVID-19, run by Soniphi LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Device used to record voice for screening
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being tested for COVID-19.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Soniphi
Sebastopol, California, 95472
M Sanderson, BS, research@soniphi.com
About this study
Official title: Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Device used to record voice for screening
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device used to record voice for screeningDevice
voice recording
| Study group | Role | What they receive |
|---|---|---|
| Control | Do not test positive for COVID Receives: Device: Device used to record voice for screening | |
| COVID-19 Positive | Test positive for Covid using swab test. Receives: Device: Device used to record voice for screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
compare Sensitivity and Specificity to standard swab test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soniphi LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UserWise, LLC
- Responsible party
- Sponsor
- Investigators
- Stephen Steady, MD, Principal investigator, Soniphi LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418544
- Sponsor's protocol ID
- 002 Soniphi
- Status last verified
- Oct 2020
- First submitted
- 1 Jun 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19
- ClinicalTrials.gov ID
- NCT04418544
- Acronym / sponsor ID
- 002 Soniphi
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Soniphi LLCIndustry (pharma, biotech, devices)
- Collaborators
- UserWise, LLC
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Device used to record voice for screeningDo not test positive for COVID |
| COVID-19 Positive | – | Device: Device used to record voice for screeningTest positive for Covid using swab test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being tested for COVID-19.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device used to record voice for screeningvoice recording | Device | COVID-19 Positive, Control |
Primary outcome
Sensitivity and Specificity
Time frame: 6 months
compare Sensitivity and Specificity to standard swab test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Steady, MD principal investigator
Soniphi LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Soniphi LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Steady, MD ((415) 309-3242, slsteady@vivacitashealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.