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

Cordio Medical

Status: Completed

Conditions: Coronavirus Infection

Treatments: Device: Cordio App

Study type: Observational

Funder types: Industry

Identifiers

NCT04325048

COV001

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)