Covid19COVID-CoughNCT04864535
A Pilot Study for the Collection Of Vocalized, Individual Digital Cough Sound Recordings to Screen for COVID-19
An observational study of Covid19, run by ResApp Health Limited at 1 site in United States.
Trial 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 collection is to develop a safe and effective cough based digital screening tool for COVID-19. 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
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 31 May 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 minimum of 100 participants who test positive for COVID-19 on rt-qPCR will be recruited. Based on average COVID-19 incidence rates in high incidence US geographies (~8-12%), this study will enrol a cohort of up to 1500 participants on a rolling basis, to allow for sufficient cough recordings from COVID-19 positive participants to be collected for analysis. 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 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)
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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 collection is to develop a safe and effective cough based digital screening tool for COVID-19.
Read the 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 can be developed to distinguish COVID-19 positive patients from COVID-19 negative patients using a combination of cough sounds with or without patient-reported symptoms.
Participants will be recruited into two arms with participants entering each arm undergoing the following procedures:
Arm 1 Participants will be recruited into Arm 1 through online marketing campaigns targeted to areas of high COVID-19 incidence as reported by the CDC. Participant recruitment campaign material will direct participants to a Study Landing Page (webpage) (See COVID Cough Study Landing Page - Wire Frame document) that will provide the high-level details of the study including the inclusion/exclusion criteria.
If participants choose to undergo the informed consent process and enroll onto the study, they will download the smartphone-based Study Research App that will virtually perform the following:
- Informed consent completion
- Inclusion/exclusion screening question
If participants are excluded, they will cease to be enrolled on the study (Screen Failure) and the Study Research App will subsequently become inactive. If participants are included, they will proceed within the Study Research App and virtually perform the following:
- Medical symptom questionnaire completion
- Cough sound recording (5 cough sound recordings)
- FDA mandated COVID-19 medical form and participant shipping information After successful completion of the final step presented by the Study Research App, participants will be shipped via FedEx a 2-day shipping FDA EUA authorized at-home self-administered, saliva-based COVID-19 rt-qPCR test developed and analyzed by a CLIA, CAP, and NYS DOH certified laboratory in Secaucus, NJ.
Participants will receive their COVID-19 rt-qPCR test within a test kit box that will also contain a study flyer designed to prompt the participant to reengage the Study Research App. Participants will also be prompted by an email sent out at the time of delivery of their COVID-19 test kit. If during the study assessment of the data shows that participant retention is poor the study PI may implement a single SMS set to the participant at the time of delivery to add an extra reminder to perform the following steps within the Study Research App alongside performing their self-administered COVID-19 test:
- Medical symptom questionnaire completion
- Cough sound recording (5 cough sound recordings) Participants will be provided a pre-paid FedEx shipping label with which to return their COVID-19 test to the study partner laboratory which will analyze tests and report test results to participants as per their standard operating procedures.
Data collected by the Study Research App will be encrypted locally on the participant's phone and uploaded to a secure, restricted access, HIPAA compliant ShareFile folder.
Data collected by the Study Research App and partner lab will also be recorded in an electronic Clinical Data Management system for security and data privacy (See COVID Cough Study Case Report Form Document).
Arm 2 Potential participants will be identified by the study staff at a partner testing site ("Partner Site") based on recently (<24 hours) receiving a positive COVID-19 test result on Rapid PCR testing. Eligible participants will be called back to attend the Partner Site within <48 hours of undergoing their COVID-19 test.
Eligible subjects will be consented and enrolled into the study through a paper Informed Consent Form that is signed in person at the Partner Site.
After enrollment, participants will be asked questions regarding any signs and symptoms of respiratory disease after which the enrolled subject's cough sounds will be captured (5 cough sounds are required) using the COVID Cough In-clinic Study application software installed on a study smartphone utilized by the Partner Site study staff. The COVID Cough In-clinic Study application software is a piece of software that mimics the cough recording capture elements of the Study Research App and provides the ability to enter a subject's date of birth for file identification purposes.
As this is an observational study, after cough recording capture the Partner Site study staff will only receive a unique cough recording identifier by the study smartphone which will be recorded in the participant's eCRF.
In both study arms participants will receive a copy of their completed ICF upon completing the ICF process.
- Conditions
- Covid19
- Being tested
- Recordings of cough sounds from adults
- Keywords
- COVID-19, Cough
- Medical subject headings
- COVID-19, Cough
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 recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR.
Cough sound recordings and symptoms from COVID-positive patients
Measured: 3 months
Development of an algorithm that uses a combination of cough sounds and self-reported symptoms that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.
Cough sound algorithm that distinguishes with COVID-19 positive and negative cough sounds.
Measured: 3 months
Secondary outcomes (1)
Development of an algorithm that uses cough sounds that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.
Algorithm for software application to distinguish between COVID-19 positive and negative coughs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 May 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResApp Health Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Strategy Health LLC, Ascada Health PC DBA
- Responsible party
- Sponsor
- Investigators
- Shrawan Patel, MBBS BSc, Principal investigator, Strategy Health LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864535
- Sponsor's protocol ID
- 21001
- Acronym
- COVID-Cough
- Status last verified
- Feb 2023
- First submitted
- 22 Apr 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 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 Screen for COVID-19
- ClinicalTrials.gov ID
- NCT04864535
- Acronym / sponsor ID
- COVID-Cough / 21001
- Conditions
- Covid19
- Keywords
- COVID-19, Cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- ResApp Health LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Strategy Health LLC, Ascada Health PC DBA
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 Apr 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 cough sounds and self-reported symptoms alongside a COVID-19 realtime quantitative polymerase chain reaction (rt-qPCR) test. The aim of the data collection is to develop a safe and effective cough based digital screening tool for COVID-19.
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 can be developed to distinguish COVID-19 positive patients from COVID-19 negative patients using a combination of cough sounds with or without patient-reported symptoms.
Participants will be recruited into two arms with participants entering each arm undergoing the following procedures:
Arm 1 Participants will be recruited into Arm 1 through online marketing campaigns targeted to areas of high COVID-19 incidence as reported by the CDC. Participant recruitment campaign material will direct participants to a Study Landing Page (webpage) (See COVID Cough Study Landing Page - Wire Frame document) that will provide the high-level details of the study including the inclusion/exclusion criteria.
If participants choose to undergo the informed consent process and enroll onto the study, they will download the smartphone-based Study Research App that will virtually perform the following:
- Informed consent completion
- Inclusion/exclusion screening question
If participants are excluded, they will cease to be enrolled on the study (Screen Failure) and the Study Research App will subsequently become inactive. If participants are included, they will proceed within the Study Research App and virtually perform the following:
- Medical symptom questionnaire completion
- Cough sound recording (5 cough sound recordings)
- FDA mandated COVID-19 medical form and participant shipping information After successful completion of the final step presented by the Study Research App, participants will be shipped via FedEx a 2-day shipping FDA EUA authorized at-home self-administered, saliva-based COVID-19 rt-qPCR test developed and analyzed by a CLIA, CAP, and NYS DOH certified laboratory in Secaucus, NJ.
Participants will receive their COVID-19 rt-qPCR test within a test kit box that will also contain a study flyer designed to prompt the participant to reengage the Study Research App. Participants will also be prompted by an email sent out at the time of delivery of their COVID-19 test kit. If during the study assessment of the data shows that participant retention is poor the study PI may implement a single SMS set to the participant at the time of delivery to add an extra reminder to perform the following steps within the Study Research App alongside performing their self-administered COVID-19 test:
- Medical symptom questionnaire completion
- Cough sound recording (5 cough sound recordings) Participants will be provided a pre-paid FedEx shipping label with which to return their COVID-19 test to the study partner laboratory which will analyze tests and report test results to participants as per their standard operating procedures.
Data collected by the Study Research App will be encrypted locally on the participant's phone and uploaded to a secure, restricted access, HIPAA compliant ShareFile folder.
Data collected by the Study Research App and partner lab will also be recorded in an electronic Clinical Data Management system for security and data privacy (See COVID Cough Study Case Report Form Document).
Arm 2 Potential participants will be identified by the study staff at a partner testing site ("Partner Site") based on recently (<24 hours) receiving a positive COVID-19 test result on Rapid PCR testing. Eligible participants will be called back to attend the Partner Site within <48 hours of undergoing their COVID-19 test.
Eligible subjects will be consented and enrolled into the study through a paper Informed Consent Form that is signed in person at the Partner Site.
After enrollment, participants will be asked questions regarding any signs and symptoms of respiratory disease after which the enrolled subject's cough sounds will be captured (5 cough sounds are required) using the COVID Cough In-clinic Study application software installed on a study smartphone utilized by the Partner Site study staff. The COVID Cough In-clinic Study application software is a piece of software that mimics the cough recording capture elements of the Study Research App and provides the ability to enter a subject's date of birth for file identification purposes.
As this is an observational study, after cough recording capture the Partner Site study staff will only receive a unique cough recording identifier by the study smartphone which will be recorded in the participant's eCRF.
In both study arms participants will receive a copy of their completed ICF upon completing the ICF process.
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 minimum of 100 participants who test positive for COVID-19 on rt-qPCR will be recruited. Based on average COVID-19 incidence rates in high incidence US geographies (~8-12%), this study will enrol a cohort of up to 1500 participants on a rolling basis, to allow for sufficient cough recordings from COVID-19 positive participants to be collected for analysis. 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 (7 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)
- have one or more medical contraindication to voluntary cough, including the following:
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 recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR.
Time frame: 3 months
Cough sound recordings and symptoms from COVID-positive patients
Development of an algorithm that uses a combination of cough sounds and self-reported symptoms that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.
Time frame: 3 months
Cough sound algorithm that distinguishes with COVID-19 positive and negative cough sounds.
1 secondary outcome
Development of an algorithm that uses cough sounds that is capable of distinguishing between COVID-19 positive and COVID-19 negative participants.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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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 LLC
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 7 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 30 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 recordings and self-reported symptoms from a minimum of 100 COVID-19 positive participants as identified by rt-qPCR. (time frame: 3 months). The study lists 2 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 30 Mar 2023.