Covid19NCT04582331
Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
An observational study of Covid19, run by Sonde Health at 4 sites in 2 countries.
Trial summary
This is a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Smartphone-based voice and self-reported symptom collection
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Sep 2020to 12 May 2021
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting with suspected COVID-19 with mild or severe disease severity.
Who may be able to join
- Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app (access to smartphone provided by parent or legal guardian of participants under the age 18 is allowed)
- Willing to sign up for a Sonde app account
- Agreement with the subject consent information presented on the Sonde app. In case of adolescent subjects, agreement with subject consent information provided by a parent or legal guardian
- Stated willingness and ability to comply with all study procedures for the duration of the study
- Male or female, aged 12 or above (including adults)
- Able to read and speak English or Spanish (required to follow app instructions and provide correct voice elicitations)
Show all 21Show fewer
- Pregnant women are allowed to participate
- For suspected COVID-19 patients:
- Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1
- Suspected COVID-19 includes patients having at least one of the following symptoms that are present at most 10 days prior to enrollment:
- Cough
- Fever (>37.5 C/ 99.5 F)
- Shortness of breath
- Sore throat
- Diarrhea
- Anosmia
- Loss of taste/ ageusia
- COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1
- For healthy volunteers:
- Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study
- Age 12 and above
Who cannot join
- Difficulties with speech production
- Difficulties reading or responding to instructions and questions on a smartphone screen
- Critical COVID-19 illness severity at screening on Day 1
- Other critical health condition where study participation would place unreasonable burden or risk on the patient as determined by the study site principal investigator
- For healthy volunteers:
- History of positive COVID-19 viral or serologic test result any time prior to enrollment
- Any hospital staff that is a member of the study team, and staff in the pulmonary and infectious disease departments of the participating institution, or any of their co-living family members
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Brigham & Woman's Hospital
Boston, Massachusetts, 02115
Montefiore Medical Center
New York, New York, 10467
UC San Diego Medical Center
San Diego, California, 92103
About this study
This is a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.
Read the detailed description
This is an observational study examining the potential to use voice analysis to aid in the identification of COVID-19 and as an aid to monitoring of respiratory symptoms of COVID-19. Patients with suspected COVID-19 and healthy controls will be enrolled and use their own smartphone device to provide daily voice samples and symptom inventories. This study seeks to confirm and extend findings from preliminary data from patients with asthma, COPD and cough that has indicated the potential of respiratory responsive vocal biomarkers (RRVB) to respond to respiratory diagnoses and symptom severity. The same RRVB will be examined to confirm whether this potential generalizes to respiratory symptoms associated with COVID-19
- Conditions
- Covid19
- Being tested
- Smartphone-based voice and self-reported symptom collection
- Keywords
- Respiratory disease, Respiratory infection, Vocal biomarkers, Digital health, Symptom monitoring
- Medical subject headings
- COVID-19, Respiration Disorders, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based voice and self-reported symptom collectionOther
Voice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | Patients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 positive status is confirmed by diagnostic testing and clinical diagnosis. Receives: Other: Smartphone-based voice and self-reported symptom collection | |
| COVID-19 negative, symptomatic | Patients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 negative status is confirmed by diagnostic testing and clinical diagnosis. Receives: Other: Smartphone-based voice and self-reported symptom collection | |
| Normal Healthy Volunteers | Asymptomatic healthy participants recruited from hospital staff or co-living family members, or co-living family member of a COVID-19 positive study participant. Receives: Other: Smartphone-based voice and self-reported symptom collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal biomarker performance in COVID-19 positive vs. healthy controls
Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to identify COVID-19 positive patients vs. asymptomatic healthy controls
Measured: Day 1 of study enrollment
Secondary outcomes (2)
Vocal biomarker vs. symptom burden correlation in COVID-19 positive
Mean and 90% confidence interval of the correlation coefficient distribution between RRVB-based scores and self-reported respiratory symptom burden pooled across study days within individual COVID-19 patients
Measured: Pooled across study Days 1-14
Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic
Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to discriminate COVID-19 positive vs. symptomatic COVID-19 negative patients on Day 1
Measured: Day 1 of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start10 Sep 2020
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonde Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582331
- Sponsor's protocol ID
- SH2020.COV01
- Status last verified
- May 2021
- First submitted
- 7 Oct 2020
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
- ClinicalTrials.gov ID
- NCT04582331
- Acronym / sponsor ID
- SH2020.COV01
- Conditions
- Covid19
- Keywords
- Respiratory disease, Respiratory infection, Vocal biomarkers, Digital health, Symptom monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sonde HealthIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Oct 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 a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.
Detailed description
This is an observational study examining the potential to use voice analysis to aid in the identification of COVID-19 and as an aid to monitoring of respiratory symptoms of COVID-19. Patients with suspected COVID-19 and healthy controls will be enrolled and use their own smartphone device to provide daily voice samples and symptom inventories. This study seeks to confirm and extend findings from preliminary data from patients with asthma, COPD and cough that has indicated the potential of respiratory responsive vocal biomarkers (RRVB) to respond to respiratory diagnoses and symptom severity. The same RRVB will be examined to confirm whether this potential generalizes to respiratory symptoms associated with COVID-19
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Other: Smartphone-based voice and self-reported symptom collectionPatients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 positive status is confirmed by diagnostic testing and clinical diagnosis. |
| COVID-19 negative, symptomatic | – | Other: Smartphone-based voice and self-reported symptom collectionPatients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 negative status is confirmed by diagnostic testing and clinical diagnosis. |
| Normal Healthy Volunteers | – | Other: Smartphone-based voice and self-reported symptom collectionAsymptomatic healthy participants recruited from hospital staff or co-living family members, or co-living family member of a COVID-19 positive study participant. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting with suspected COVID-19 with mild or severe disease severity.
Key inclusion criteria (21 listed)
- Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app (access to smartphone provided by parent or legal guardian of participants under the age 18 is allowed)
- Willing to sign up for a Sonde app account
- Agreement with the subject consent information presented on the Sonde app. In case of adolescent subjects, agreement with subject consent information provided by a parent or legal guardian
- Stated willingness and ability to comply with all study procedures for the duration of the study
- Male or female, aged 12 or above (including adults)
Key exclusion criteria (7 listed)
- Difficulties with speech production
- Difficulties reading or responding to instructions and questions on a smartphone screen
- Critical COVID-19 illness severity at screening on Day 1
- Other critical health condition where study participation would place unreasonable burden or risk on the patient as determined by the study site principal investigator
- History of positive COVID-19 viral or serologic test result any time prior to enrollment
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 |
|---|---|---|
| Smartphone-based voice and self-reported symptom collectionVoice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study | Other | COVID-19 negative, symptomatic, COVID-19 positive, Normal Healthy Volunteers |
Primary outcome
Vocal biomarker performance in COVID-19 positive vs. healthy controls
Time frame: Day 1 of study enrollment
Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to identify COVID-19 positive patients vs. asymptomatic healthy controls
2 secondary outcomes
Vocal biomarker vs. symptom burden correlation in COVID-19 positive
Time frame: Pooled across study Days 1-14
Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic
Time frame: Day 1 of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Sonde Health at 4 sites in 2 countries.
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 21 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal biomarker performance in COVID-19 positive vs. healthy controls (time frame: Day 1 of study enrollment). 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 14 May 2021.