Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Decentralized clinical study designed to collect further cough sounds, self-reported symptoms, and medical treatment questionnaires from participants enrolled on the COVID-Cough Study ("Study 1").
The aim of this further data collection study ("Study 2") is to:
This study is designed to be administered in a decentralized manner to collect self-reported COVID-19 symptoms, cough sample recordings and descriptions of recent medical treatment to investigate the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recordings of cough sounds from adults | Diagnostic Test | Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of cough sound audio recordings made using a smartphone, self-reported respiratory symptoms, COVID-19 rt-qPCR result and medical treatment information on 3 occasions (day 1, day 10, day 25). | 6 months | |
| Sensitivity and specificity of using cough sound analysis on longitudinal cough sounds to detect COVID-19 as compared to rt-qPCR test. | 10 months | |
| Sensitivity and specificity of longitudinal cough sounds to detect whether study participants have required recent medical care for COVID-19 related illness. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Confusion matrix outputs of cough sound algorithm prediction of COVID-19 severity compared against COVID-19 severity measured by a combination of medical history survey and rt-qPCR test. | 10 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participant has one or more medical contraindication to voluntary cough, including the following:
Not provided
Not provided
Not provided
A list of COVID-19 positive and negative participants, and their consent to inform them of this study (and possible future studies) will be created through the administration of Study 1. Using this list of potential study participants we seek to enroll as many participants identified through Study 1 as possible (up to 1,500 individuals). Participants will be aged 21 years and older and will not be excluded based on gender, demographic group, or geographic location within the US.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shrawan Patel, MBBS,BSc | Strategy Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strategy Health LLC | New York | New York | 10024 | United States |
No plan to share IPD.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |