Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Coronavirus Infection

Keywords

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COVID-19 positive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cordio App

Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18+ years old
2. 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.
3. 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).

Exclusion Criteria

1. Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
2. Patients with severe alcohol or drug use.
3. Women who are pregnant or lactating.
4. Participating in another investigation therapy that may interfere with study results (according to investigator discretion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zaher Azzam, Prof

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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COV001

Identifier Type: -

Identifier Source: org_study_id