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

Sponsor

Sonde Health (Industry)

Overall Status

Completed

CT.gov ID

NCT04582331

Collaborator

(none)

500

Enrollment

Locations

Actual Duration (Months)

125

Patients Per Site

15.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	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 Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 10, 2020

Actual Primary Completion Date :

May 12, 2021

Actual Study Completion Date :

May 12, 2021

Arms and Interventions

Arm	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

Arm

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

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

Outcome Measures

Primary Outcome Measures

Vocal biomarker performance in COVID-19 positive vs. healthy controls [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

Secondary Outcome Measures

Vocal biomarker vs. symptom burden correlation in COVID-19 positive [Pooled across study Days 1-14]
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
Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic [Day 1 of enrollment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC San Diego Medical Center	San Diego	California	United States	92103
2	Brigham & Woman's Hospital	Boston	Massachusetts	United States	02115
3	Montefiore Medical Center	New York	New York	United States	10467
4	Deenanath Mangeshkar Hospital & Research Centre	Pune		India