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NCT04457817 · ClinicalTrials.gov registry record

Compensatory Reserve Index (CRI) for Management of COVID-19

A clinical trial, sponsored by University of Colorado, Denver.

Terminated
Registry status
16
Enrollment target

NCT04457817: Clinical Trial study, sponsored by University of Colorado, Denver.

NCT04457817 is a clinical trial that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04457817 was terminated before completion, sponsored by University of Colorado, Denver.

TERMINATED
Registry status
16 participants
Enrollment target

Study Summary

The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.

Primary Outcome

Volume of IV fluid infused during treatment

Interventions

  • DEVICE CRI

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2020-12-01
Est. Completion 2021-04-08
University of Colorado, Denver

1,283 total trials

Why NCT04457817 stopped before completion

NCT04457817 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which CRI is the first listed.

NCT04457817 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04457817 about?

NCT04457817 is a clinical study titled "Compensatory Reserve Index (CRI) for Management of COVID-19". The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research...

What is the current status of trial NCT04457817?

This trial is currently terminated. The enrollment target is 16 participants. The study started on 2020-12-01. Estimated completion is 2021-04-08.

What interventions are being tested in trial NCT04457817?

The interventions under investigation include: CRI (DEVICE).

Who is sponsoring clinical trial NCT04457817?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04457817, the US trial registry maintained by the National Library of Medicine. NCT04457817 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.