Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Sonde Health
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMs Ulka Gaikwad
Quest Clinical Services
Outcome results
None listed