Covid19NCT04725097
A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection
An observational study of Covid19, run by Mayo Clinic at 10 sites in 4 countries.
Trial summary
The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Covid19
- How many people
- 2,821 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 10 Dec 2020to 3 Jun 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Detection of COVID-19 when compared to a PCR test in asymptomatic patients.
Who may be able to join
- Adult males and females age 18 or greater.
- Undergoing COVID-19 testing by PCR.
- Willing and able to provide informed consent.
- Pregnant females (minimal risk study, no risk from ECG).
Who cannot join
- Unwilling or unable to provide informed consent.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States6 sites
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55902
LSUHSC Shreveport
Shreveport, Louisiana, 71103
Henry Ford Health System
West Bloomfield, Michigan, 48322
India2 sites
Sri Jayadeva
Bengaluru, Karnataka
King Edward Memorial Hospital
Mumbai, Maharashtra, 400 012
About this study
Official title: Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study
The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID 19 Detection
Determine the safety and feasibility of the POC AI-ECG's ability to detect active SARS-Cov-2 infection in humans.
Measured: One time screening within 4 hours of PCR test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start10 Dec 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Why it stopped: Interim analysis indicated adaptions may be required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 2,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie F. Berbari, Mayo Clinic
- Investigators
- Elie F Berbari, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725097
- Sponsor's protocol ID
- 20-011415
- Status last verified
- Sep 2021
- First submitted
- 25 Jan 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adedinsewo D, Dugan J, Johnson PW, Douglass EJ, Morales-Lara AC, Parkulo MA, Ting HH, Cooper LT, Scott LR, Valverde AM, Padmanabhan D, Peters NS, Bachtiger P, Kelshiker M, Fernandez-Aviles F, Atienza F, Glotzer TV, Lahiri MK, Dominic P, Attia ZI, Kapa S, Noseworthy PA, Pereira NL, Cruz J, Berbari EF, Carter RE, Friedman PA. RApid Throughput Screening for Asymptomatic COVID-19 Infection With an Electrocardiogram: A Prospective Observational Study. Mayo Clin Proc Digit Health. 2023 Sep 16;1(4):455-466. doi: 10.1016/j.mcpdig.2023.07.007. eCollection 2023 Dec.
PubMed 40206301
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study
- ClinicalTrials.gov ID
- NCT04725097
- Acronym / sponsor ID
- 20-011415
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated adaptions may be required.
- Enrolment
- 2,821 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 26 Jan 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.
The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Detection of COVID-19 when compared to a PCR test in asymptomatic patients.
Key inclusion criteria (4 listed)
- Adult males and females age 18 or greater.
- Undergoing COVID-19 testing by PCR.
- Willing and able to provide informed consent.
- Pregnant females (minimal risk study, no risk from ECG).
Key exclusion criteria (1 listed)
- Unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID 19 Detection
Time frame: One time screening within 4 hours of PCR test
Determine the safety and feasibility of the POC AI-ECG's ability to detect active SARS-Cov-2 infection in humans.
Results and safety
The study was stopped early (reason given: Interim analysis indicated adaptions may be required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 40206301Adedinsewo D, Dugan J, Johnson PW, Douglass EJ, Morales-Lara AC, Parkulo MA, Ting HH, Cooper LT, Scott LR, Valverde AM, Padmanabhan D, Peters NS, Bachtiger P, Kelshiker M, Fernandez-Aviles F, Atienza F, Glotzer TV, Lahiri MK, Dominic P, Attia ZI, Kapa S, Noseworthy PA, Pereira NL, Cruz J, Berbari EF, Carter RE, Friedman PA. RApid Throughput Screening for Asymptomatic COVID-19 Infection With an Electrocardiogram: A Prospective Observational Study. Mayo Clin Proc Digit Health. 2023 Sep 16;1(4):455-466. doi: 10.1016/j.mcpdig.2023.07.007. eCollection 2023 Dec.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Elie F Berbari, MD principal investigator
Mayo Clinic
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Mayo Clinic at 10 sites in 4 countries.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, India, Spain, United Kingdom. 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?
The study was stopped early (reason given: Interim analysis indicated adaptions may be required.). 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?
COVID 19 Detection (time frame: One time screening within 4 hours of PCR test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725097, which also lists 1 linked publication.
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 2021.