Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients
Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19
1 other identifier
observational
42
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2021
CompletedDecember 12, 2023
December 1, 2023
1 year
March 25, 2020
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Voice anaysis
patient voice that is recorded during the study will be anylaysis with specific algorithms
1-2 years
Interventions
Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app
Eligibility Criteria
COVID-19 positive patients, from medical center departments, ER, home/hotels hospitalization
You may qualify if:
- + 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordio Medicallead
Study Sites (1)
Rambam Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zaher Azzam, Prof
Rambam Health Care Campus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 27, 2020
Study Start
April 23, 2020
Primary Completion
May 2, 2021
Study Completion
September 29, 2021
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share