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: 1. develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease; 2. develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.
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:
1. Whether patterns unique to COVID-19 disease can be detected in cough sounds collected
over time;
2. The incidence of COVID-19 and other lung diseases within individuals who test negative
for COVID-19;
3. Whether existing machine learning algorithms can detect the presence of disease in the
lower respiratory tract in participants; and
4. Whether distinct cough sound patterns in COVID-19 disease are associated with the
requirement of medical treatment for COVID-19 disease. Through the administration of
Study 1, a list of potential participants will be created for whom the result of a
recent rt-qPCR COVID-19 test is known. Participants have been consented to allow for
outreach regarding further studies. Cough samples and answers to medical questions have
been collected from these individuals at the time of testing, and the aim of Study 2 is
to gather further cough samples and questionnaire answers over a period of 25 days.
Diagnostic Test: Recordings of cough sounds from adults
Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result.
Inclusion Criteria:
- 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 willing to follow study procedures;
- be able to provide at least 5 coughs (voluntary and/or spontaneous);
- have enrolled in the COVID-Cough Study and successfully returned an at-home rt-qPCR
test to the study partner laboratory
Exclusion Criteria:
Participant has 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;
Strategy Health LLC
New York, New York, United States
Shrawan Patel, MBBS,BSc, Principal Investigator
Strategy Health