Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
ResApp Health Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. be aged 18 years and older 2. be able to provide informed consent 3. be willing to follow study procedures 4. be able to provide at least 5 coughs (voluntary and/or spontaneous) and 5. Is either • an in-patient at a study site who are experiencing mild to moderate symptoms of COVID- 19 based on the ICMR guidelines, and has undergone a positive COVID19 rtPCR or rtqPCR test in the preceding 48 hours (not applicable to v 0.2 protocol) or • at a study site and is needing a COVID19 rtPCR or rtqPCR test.
Exclusion criteria
Exclusion criteria: 1. Participant has one or more medical contraindication to voluntary cough, including the following o Severe respiratory distress o History of pneumothorax; o Eye, chest, or abdominal surgery within 3 months of enrolling for the study o Hemoptysis (coughing up of blood) within 1 month of enrolling for the study or o Patient is requiring continuous oxygen or ventilator support.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of cough sound recordings, current medical symptoms, and medical history on a single occasion from 120 COVID-19 negative or positive participants as identified by PCR. Collection of cough sound recordings, current medical symptoms, medical history, and medical treatment information on 3 distinct occasions (day 0, day 2, day 4) from 100 individuals with a known positive COVID-19 PCR result. To develop a post data collection algorithm to detect COVID-19 and the severity of COVID-19 and determine the accuracy of the developed algorithm with a combination of collected cough sound analysis and medical symptoms to detect COVID-19 and the severity of COVID-19 using PCR as a reference standard.Timepoint: Screening/Baseline Visit, Day 2 and Day 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactSuresh Kumar Karri
Triomics Healthcare Private Limited
Outcome results
None listed