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NCT04581863 · ClinicalTrials.gov registry record · NA

COVID-19 Watch + COVID-19 Pulse

A NA study, sponsored by University of Pennsylvania.

Completed
Registry status
NA
Development phase
2,097
Enrollment target

NCT04581863: Completed NA study, sponsored by University of Pennsylvania.

NCT04581863 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 2,097 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04581863, a NA study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
NA
Development phase
2,097 participants
Enrollment target

Study Summary

The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive

Primary Outcome

Primary outcome will be reported for patients who are confirmed to be COVID positive. Outcomes include time-based and categorical clinical outcomes. Time-based measures will be assessed at 30 days and begin when a COVID-19 patient was tested (e.g., nasopharyngeal swab) in outpatient and ED settings, or starting at the time of discharge from the hospital if enrolled in COVID Watch as an inpatient. Staying safe and out of the hospital using Days Alive and Out of Hospital (DAOH) since the date of t

Interventions

  • DEVICE pulse oximeter
  • OTHER COVID Watch

Trial Details

FieldValue
Enrollment Target 2,097 participants
Start Date 2020-11-30
Est. Completion 2022-05-31
Phase NA
University of Pennsylvania

1,423 total trials

What the finished NCT04581863 record still lists

NCT04581863 is an interventional study that assigns participants to a tested intervention. Its 2,097 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% higher).

The record links to 0 conditions, and to 2 interventions - of which pulse oximeter is the first listed.

NCT04581863 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04581863 about?

NCT04581863 is a clinical study titled "COVID-19 Watch + COVID-19 Pulse". The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly de...

What is the current status of trial NCT04581863?

This trial is currently completed. It is a NA study. The enrollment target is 2,097 participants. The study started on 2020-11-30. Estimated completion is 2022-05-31.

What interventions are being tested in trial NCT04581863?

The interventions under investigation include: pulse oximeter (DEVICE), COVID Watch (OTHER).

Who is sponsoring clinical trial NCT04581863?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04581863's enrollment target sits among peer trials

2,097 50th of 2000 higher than 1,951 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04581863, the US trial registry maintained by the National Library of Medicine. NCT04581863 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.