Status:
UNKNOWN
A Pilot Study for the Collection Of Vocalized, Individual Digital Cough Sound Recordings to Screen for COVID-19
Lead Sponsor:
ResApp Health Limited
Collaborating Sponsors:
Strategy Health LLC
Ascada Health PC DBA
Conditions:
Covid19
Eligibility:
All Genders
21+ years
Brief Summary
Decentralized clinical study designed to collect cough sounds and self-reported symptoms alongside a COVID-19 realtime quantitative polymerase chain reaction (rt-qPCR) test. The aim of the data collec...
Detailed Description
This study is designed to be administered in a hybrid manner to collect cough sample recordings in association with self-reported symptoms and a COVID-19 rt-qPCR test to investigate whether algorithms...
Eligibility Criteria
Inclusion
- be aged 21 years and older;
- be a resident of the USA;
- have a personal (i.e., not shared) iPhone 6s or newer running iOS 14 or later;
- be able to read and understand English;
- be able to provide informed consent;
- be able to provide at least 5 coughs (voluntary and/or spontaneous);
- if enrolling online in Arm 1, the participant must be unvaccinated against COVID-19 (have not received one or more doses of a COVID-19 vaccine at any time before study enrolment)
Exclusion
- have one or more medical contraindication to voluntary cough, including the following:
- Severe respiratory distress;
- History of pneumothorax;
- Eye, chest, or abdominal surgery within 3 months of enrolling for the study; or
- Hemoptysis (coughing up of blood) within 1 month of enrolling for the study;
Key Trial Info
Start Date :
May 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04864535
Start Date
May 12 2021
End Date
May 31 2023
Last Update
March 30 2023
Active Locations (1)
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1
Strategy Health LLC
New York, New York, United States, 10024