COVID-19 Remote Monitoring

COVID-19 Clinical Trial

Official title:

Remote Monitoring in Patients With Coronavirus Disease (COVID-19)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04350476
• Other study ID #: GCO 20-0932
• Status: Withdrawn
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting.

Description:

The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting. This study will enroll COVID-19 positive patients previously evaluated at Mount Sinai Hospital/Mount Sinai Health System (MSHS) and affiliated hospitals deemed appropriate for home monitoring. Patients will be monitored remotely in the outpatient setting for 1-3 weeks following diagnosis and/or treatment for COVID-19 at MSH/MSHS.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either

1. Not admitted to the hospital, and permitted to recover at home

2. Discharged from inpatient hospitalization, during the acute recovery period

• 18 years old or older with the ability to understand the requirements of the study and sign the informed consent form (or able to provide over-the-phone verbal consent).

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• COVID-19

Intervention

Diagnostic Test:
• VitalConnect Vital Sign Patch
This patch provides continuous real-time monitoring of cardiac telemetry, heart rate, respiratory rate and oxygen saturation. Duration of monitoring is typically up to 7 days. This patch is applied to the upper left side of the chest wall, attached with a hypoallergenic adhesive material. (This device is FDA approved for this indication).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vivek Reddy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of different arrhythmias	ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH	7-14 Days
Primary	Temperature	Temperature of patients with COVID-19 infection following treatment/discharge from MHS	7-14 Days
Primary	Oxygen Saturation	Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH	7-14 Days