CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
LifeSignals Biosensor 1AX* +1 moredevice
Likely dose
LifeSignals Biosensor 1AX (continuous remote patient monitoring)AI-extracted
Key inclusion· 2
  • Confirmed COVID-19 positive
  • Does not require hospitalization (outpatient only)
Key exclusion· 3
  • Allergic to sensor patch material
  • Has implanted pacemaker
  • Has excessive sweating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04425720
NCT04425720N/ACompleted

Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient

Montefiore Medical Center·interventional·Posted Jun 11, 2020·Updated Jan 24, 2022

In Brief

A clinical study evaluating LifeSignals Biosensor 1AX* and Standard of Care for COVID. Completed, enrolled 300 participants across 1 site.

Detailed Summary

The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartSep 1, 2020
Primary CompletionFeb 10, 2021
Study CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.1 years ago

Interventions

LifeSignals Biosensor 1AX*device

Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\* and a pulse oximeter.

Standard of Careother

This group will be treated based on standard of care at our institution.