NCT04425720: RPM

Use of Remote Monitoring for COVID-19 Patient

Completed NA Results posted Last updated 24 January 2022

What this trial tests

NA trial testing LifeSignals Biosensor 1AX* in COVID in 300 participants. Completed in 10 December 2021.

Timeline

1 September 2020

Primary endpoint
10 February 2021

10 December 2021

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	300
Start date	1 September 2020
Primary completion	10 February 2021
Estimated completion	10 December 2021
Sites	1 location across United States

Drugs / interventions tested

• LifeSignals Biosensor 1AX*
• Standard of Care

Conditions studied

• COVID — all drugs for COVID →

Sponsor

Montefiore Medical Center

Who can join

Adults 18 to 90, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Monitored Versus Non-Monitored In-patient Admission Primary · 14 days

compare the number of in-patient admissions between the monitored and non-monitored patients

Group	Value	95% CI
Standard Of Care	8
Monitored	9

How Many Subjects Needed to Visit the Emergency Department Primary · 14 days

compare the number of participants who visited Emergency Department between both arms

Group	Value	95% CI
Standard Of Care	14
Monitored	12

Length of Stay Primary · 14 days

Length of stay of subject if hospitalized

Group	Value	95% CI
Standard Of Care	7	1 – 14
Monitored	7	4.5 – 9.5

How Many Completed the Patient Satisfaction Survey Primary · 14 days

Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.

Group	Value	95% CI
Monitored	84

How Many Subjects End up Requiring Mechanical Ventilation and ECMO Primary · 14 days

How often does a subject end up getting mechanical ventilation or ECMO

Group	Value	95% CI
Monitored	0

Serious Adverse Events Primary · 14 days

events requiring extended hospital stay

Group	Value	95% CI
Standard Of Care	2
Monitored	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 17 days after admission. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Of Care

Serious: 2/150 (1%)

Deaths: 2/150

Monitored

Serious: 1/130 (1%)

Deaths: 1/130

Serious adverse events (1 terms)

Reaction	System	Standard Of Care	Monitored
Death	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Standard Of Care	Monitored
Repeated Admission	Infections and infestations	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT04425720 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Point-of-Care Biosensor-Based Diagnosis of COVID-19 Holds Promise to Combat Current and Future Pandemics.
   Parihar A, Ranjan P, Sanghi SK, Srivastava AK, et al · · 2020 · cited 90× · PMID 35019474 · DOI 10.1021/acsabm.0c01083
2. [Ethics of resuscitation and end of life decisions].
   Mentzelopoulos SD, Couper K, Van de Voorde P, Druwé P, et al · · 2021 · cited 5× · PMID 34093076 · DOI 10.1007/s10049-021-00888-8