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

A Pilot Study for the Collection of Vocalized, Individual Digital Cough Sound Recordings to Understand COVID-19-like Symptom Progression

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Recordings of cough sounds from adults

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10024
      • Strategy Health LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ResApp Health Limited
• Investigators: Principal Investigator: Shrawan Patel, MBBS,BSc, Strategy Health

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 21002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No