Covid19NCT04989452
Cough Sound Recordings to Understand COVID-19-like Symptom Progression to Understand COVID-19-like Symptom Progression
An observational study of Covid19, run by ResApp Health Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Recordings of cough sounds from adults
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease;
- develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and
- gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.
Read the 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:
- Whether patterns unique to COVID-19 disease can be detected in cough sounds collected over time;
- The incidence of COVID-19 and other lung diseases within individuals who test negative for COVID-19;
- Whether existing machine learning algorithms can detect the presence of disease in the lower respiratory tract in participants; and
- 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
- Being tested
- Recordings of cough sounds from adults
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recordings of cough sounds from adultsDiagnostic test
Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Sensitivity and specificity of using cough sound analysis on longitudinal cough sounds to detect COVID-19 as compared to rt-qPCR test.
Measured: 10 months
Sensitivity and specificity of longitudinal cough sounds to detect whether study participants have required recent medical care for COVID-19 related illness.
Measured: 10 months
Secondary outcomes (1)
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start10 Aug 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResApp Health Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shrawan Patel, MBBS,BSc, Principal investigator, Strategy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989452
- Sponsor's protocol ID
- 21002
- Status last verified
- Mar 2023
- First submitted
- 30 Jul 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Collection of Vocalized, Individual Digital Cough Sound Recordings to Understand COVID-19-like Symptom Progression
- ClinicalTrials.gov ID
- NCT04989452
- Acronym / sponsor ID
- 21002
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ResApp Health LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease;
- develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and
- 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:
- Whether patterns unique to COVID-19 disease can be detected in cough sounds collected over time;
- The incidence of COVID-19 and other lung diseases within individuals who test negative for COVID-19;
- Whether existing machine learning algorithms can detect the presence of disease in the lower respiratory tract in participants; and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recordings of cough sounds from adultsSmartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result. | Diagnostic test | – |
Primary outcome
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).
Time frame: 6 months
Sensitivity and specificity of using cough sound analysis on longitudinal cough sounds to detect COVID-19 as compared to rt-qPCR test.
Time frame: 10 months
Sensitivity and specificity of longitudinal cough sounds to detect whether study participants have required recent medical care for COVID-19 related illness.
Time frame: 10 months
1 secondary outcome
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.
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shrawan Patel, MBBS,BSc principal investigator
Strategy Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by ResApp Health Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.