Improving real-time COVID-19 monitoring through smartphone voice analysis

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/09/027691
• Lead Sponsor: Sonde Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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 Marathi (required to follow app instructions and provide correct voice elicitations)

7 Pregnant women are allowed to participate

Only for subjects in subgroups 1a and 1b (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 oC/ 99.5 oF)

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

Only for subjects in subgroup 2:

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

An individual who meets any of the following criteria will be excluded from participation in this study:

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 subjects in subgroup 2:

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 & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the 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 on Day 1Timepoint: Day 1 to 14, each day

Secondary Outcome Measures

Name	Time	Method
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 patientsTimepoint: within 3 Months;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 1Timepoint: Day 1 to 14, each day