Coronavirus InfectionNCT04325048
Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients
An observational study of Coronavirus Infection, run by Cordio Medical at 1 site in Israel.
Trial summary
Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Cordio App
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Apr 2020to 29 Sep 2021
- How long will I take part?
- 2 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 positive patients, from medical center departments, ER, home/hotels hospitalization
Who may be able to join
- 18+ years old
- Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT.
- Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients).
Who cannot join
- Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
- Patients with severe alcohol or drug use.
- Women who are pregnant or lactating.
- Participating in another investigation therapy that may interfere with study results (according to investigator discretion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19
Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet.
The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.
- Conditions
- Coronavirus Infection
- Being tested
- Cordio App
- Keywords
- COVID-19 positive
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordio AppDevice
Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice anaysis
patient voice that is recorded during the study will be anylaysis with specific algorithms
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Apr 2020
- Primary completion2 May 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- 42 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Cordio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaher Azzam, Prof, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325048
- Sponsor's protocol ID
- COV001
- Status last verified
- Dec 2023
- First submitted
- 25 Mar 2020
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19
- ClinicalTrials.gov ID
- NCT04325048
- Acronym / sponsor ID
- COV001
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19 positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cordio MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 27 Mar 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.
Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet.
The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 positive patients, from medical center departments, ER, home/hotels hospitalization
Key inclusion criteria (3 listed)
- 18+ years old
- Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT.
- Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients).
Key exclusion criteria (4 listed)
- Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
- Patients with severe alcohol or drug use.
- Women who are pregnant or lactating.
- Participating in another investigation therapy that may interfere with study results (according to investigator discretion)
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 |
|---|---|---|
| Cordio AppAdult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app | Device | – |
Primary outcome
Voice anaysis
Time frame: 1-2 years
patient voice that is recorded during the study will be anylaysis with specific algorithms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 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.
Zaher Azzam, Prof principal investigator
Rambam Health Care Campus
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 Coronavirus Infection, run by Cordio Medical at 1 site in Israel.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Voice anaysis (time frame: 1-2 years). 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 12 Dec 2023.