Cough Sound Recordings to Understand COVID-19-like Symptom Progression to Understand COVID-19-like Symptom Progression

NCT ID: NCT04989452

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2023-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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;

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ResApp Health Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shrawan Patel, MBBS,BSc

Role: PRINCIPAL_INVESTIGATOR

Strategy Health

Locations

Strategy Health LLC

New York, New York, United States

Countries

United States

Other Identifiers

21002

Identifier Type: -

Identifier Source: org_study_id