COVID-19NCT04350476
COVID-19 Remote Monitoring
A study testing VitalConnect Vital Sign Patch in people with COVID-19 and Cardiac Arrhythmias, run by Vivek Reddy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cardiac Arrhythmias
- What is being tested?
- VitalConnect Vital Sign Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2020to 1 May 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either
- Not admitted to the hospital, and permitted to recover at home
- 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).
Who cannot join
- N/A
About this study
Official title: Remote Monitoring in Patients With Coronavirus Disease (COVID-19)
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.
Read the detailed 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.
- Conditions
- COVID-19, Cardiac Arrhythmias
- Being tested
- VitalConnect Vital Sign Patch
- Keywords
- COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry
- Medical subject headings
- COVID-19, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalConnect Vital Sign PatchDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Vital Connect Patch Arm | Other | This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system:
VitalConnect Vital Sign Patch (FDA approved for this indication) Receives: Diagnostic Test: VitalConnect Vital Sign Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of different arrhythmias
ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH
Measured: 7-14 Days
Temperature
Temperature of patients with COVID-19 infection following treatment/discharge from MHS
Measured: 7-14 Days
Oxygen Saturation
Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH
Measured: 7-14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start17 Apr 2020
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: closed due to lack of interest and enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (San Jose, California) 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Y Reddy, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMartin Goldman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350476
- Sponsor's protocol ID
- GCO 20-0932
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring in Patients With Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04350476
- Acronym / sponsor ID
- GCO 20-0932
- Conditions
- COVID-19, Cardiac Arrhythmias
- Keywords
- COVID-19, Cardiac Arrhythmias, Atrial Fibrillation, Telemetry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed due to lack of interest and enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (San Jose, California) 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).
| Arm | Type | Receives |
|---|---|---|
| Vital Connect Patch Arm | Other | Diagnostic Test: VitalConnect Vital Sign PatchThis is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (FDA approved for this indication) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either
- 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).
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| VitalConnect Vital Sign PatchThis 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). | Diagnostic test | Vital Connect Patch Arm |
Primary outcome
Number of different arrhythmias
Time frame: 7-14 Days
ac rhythm in patients with COVID-19 infection following treatment/discharge from MSH
Temperature
Time frame: 7-14 Days
Temperature of patients with COVID-19 infection following treatment/discharge from MHS
Oxygen Saturation
Time frame: 7-14 Days
Oxygen saturation level in patients with COVID-19 infection following treatment/discharge from MSH
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Vivek Y Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
Martin Goldman, MD principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A study testing VitalConnect Vital Sign Patch in people with COVID-19 and Cardiac Arrhythmias, run by Vivek Reddy.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of different arrhythmias (time frame: 7-14 Days). The study lists 3 primary outcomes in all. 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 20 Aug 2020.