Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis

Covid19 Clinical Trial

Official title:

Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582331
• Other study ID #: SH2020.COV01
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: May 2021
• Source: Sonde Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. 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)

2. Willing to sign up for a Sonde app account

3. 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

4. Stated willingness and ability to comply with all study procedures for the duration of the study

5. Male or female, aged 12 or above (including adults)

6. Able to read and speak English or Spanish (required to follow app instructions and provide correct voice elicitations)

7. Pregnant women are allowed to participate

For suspected COVID-19 patients:

8. Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1

9. 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

10. COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1

For healthy volunteers:

11. Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study

12. Age 12 and above

Exclusion Criteria:

1. Difficulties with speech production

2. Difficulties reading or responding to instructions and questions on a smartphone screen

3. Critical COVID-19 illness severity at screening on Day 1

4. 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:

5. History of positive COVID-19 viral or serologic test result any time prior to enrollment

6. 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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Smartphone-based voice and self-reported symptom collection
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

Locations

Country	Name	City	State
India	Deenanath Mangeshkar Hospital & Research Centre	Pune
United States	Brigham & Woman's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	New York	New York
United States	UC San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonde Health

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 of study enrollment
Secondary	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	Pooled across study Days 1-14
Secondary	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	Day 1 of enrollment