Clinical trial NCT04582331: Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
Official title: Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Respiratory disease
Respiratory infection
Vocal biomarkers
Digital health
Symptom monitoring
Lead sponsor: Sonde Health
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with suspected COVID-19 with mild or severe disease severity.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Vocal biomarker performance in COVID-19 positive vs. healthy controls
timeFrame: Day 1 of study enrollment
Secondary outcomes:
measure: Vocal biomarker vs. symptom burden correlation in COVID-19 positive
timeFrame: Pooled across study Days 1-14
measure: Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic
timeFrame: Day 1 of enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: Boston
country: United States
facility: Brigham & Woman's Hospital
state: Massachusetts
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
Study officials:
References: