COVID-19NCT04341506
Non-contact ECG Sensor System for COVID19
An observational study of COVID-19, run by Northwestern Medicine at 1 site in United States.
Trial summary
The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Non-contact ECG
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 15 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 employees of Lake Forrest Memorial Hospital
Who may be able to join
- Any employee of Lake Forrest Memorial Hospital presenting to work
- Age greater than 18 years-old
Who cannot join
- Age less than 18 years-old
- Non-employee
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60610
Andrew Gostine
About this study
Official title: Evaluating Non-contact ECG Sensor System for Early Detection of COVID19
The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.
- Conditions
- COVID-19
- Being tested
- Non-contact ECG
- Keywords
- COVID-19, ECG, Arrhythmia
- Medical subject headings
- COVID-19, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact ECGDevice
A non-contact ECG will be used to detect a patient cardiac electrical activity.
| Study group | Role | What they receive |
|---|---|---|
| Participant ECG | The study has one arm, I.e., we will collect daily ECGs in 100 participants and track their ECG over three months. We will then compare ECGs pre and post COVID-19 diagnosis in any participant diagnosed with COVID-19 to assess for any early ECG changes that may aid with diagnosing. Receives: Device: Non-contact ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG changes associated with COVID-19
Assess different ECG changes in participants diagnosed with COVID-10
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 posted10 Apr 2020
- Study start8 Sep 2020
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Gostine, MD, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341506
- Sponsor's protocol ID
- 20-0407
- Status last verified
- Sep 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Non-contact ECG Sensor System for Early Detection of COVID19
- ClinicalTrials.gov ID
- NCT04341506
- Acronym / sponsor ID
- 20-0407
- Conditions
- COVID-19
- Keywords
- COVID-19, ECG, Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern MedicineUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 10 Apr 2020 (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.
The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant ECG | – | Device: Non-contact ECGThe study has one arm, I.e., we will collect daily ECGs in 100 participants and track their ECG over three months. We will then compare ECGs pre and post COVID-19 diagnosis in any participant diagnosed with COVID-19 to assess for any early ECG changes that may aid with diagnosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 employees of Lake Forrest Memorial Hospital
Key inclusion criteria (2 listed)
- Any employee of Lake Forrest Memorial Hospital presenting to work
- Age greater than 18 years-old
Key exclusion criteria (2 listed)
- Age less than 18 years-old
- Non-employee
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 |
|---|---|---|
| Non-contact ECGA non-contact ECG will be used to detect a patient cardiac electrical activity. | Device | Participant ECG |
Primary outcome
ECG changes associated with COVID-19
Time frame: 3 months
Assess different ECG changes in participants diagnosed with COVID-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
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 COVID-19, run by Northwestern Medicine 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 2 inclusion and 2 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 9 Sep 2020. 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?
Contact Andrew Gostine, MD ((312) 695-0061, andrew.gostine@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG changes associated with COVID-19 (time frame: 3 months). 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 9 Sep 2020.