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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Smartphone-based voice and self-reported symptom collection

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• India
  • Pune, India
    • Deenanath Mangeshkar Hospital & Research Centre
• United States
  • California
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Woman's Hospital
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with suspected COVID-19 with mild or severe disease severity.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sonde Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2020
• Primary Completion (ACTUAL): May 12, 2021
• Study Completion (ACTUAL): May 12, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Respiratory infection; Respiratory disease; Digital health; Symptom monitoring; Vocal biomarkers
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SH2020.COV01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No