COVID-19 And Geko Evaluation: The CAGE Study (CAGE)

October 5, 2023 updated by: Lawson Health Research Institute

The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19.

Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

On March 11, 2020, a global pandemic was declared by the World Health Organization. A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of the COVID-19 pandemic. SARS-CoV-2 infection has quickly become one of the fastest growing and deadliest diseases to surface due to its high death rate and ability to replicate and spread readily from people without symptoms. Recent evidence indicates that critically ill patients with COVID-19 experience a high risk of blood clots. Deep leg vein blood clots can travel to the lungs and cause severe lung failure and death. The geko™ device is a simple device that increases the return of blood flow from the lower legs and potentially decrease the risk of lung blood clots. Investigators believe the geko™ device may have an important benefit in COVID-19 patients by decreasing the risk of lung clots and decrease the risk of respiratory failure which is often the cause of death in COVID-19 patients. In this study, Investigators plan to study the effect of using the geko™ device in COVID-19 patients and measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who test positive for Covid-19

Exclusion Criteria:

  • Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
  • Prior above or below knee amputation
  • A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
  • Those patients being treated with full dose therapeutic anticoagulation.
  • Patients with pacemakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geko Device
Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.
Device: geko T3
The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.
Other Names:
  • NMES
No Intervention: No Device
Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment
Time Frame: Within a two year period
Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria
Within a two year period
Safety of device: AE
Time Frame: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
We will measure the rate of adverse events, primarily local site irritation or discomfort
From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
Protocol Adherence
Time Frame: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
We will assess our ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment
From ICU admission to discharge or death in ICU up to 28 days whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.
The impact of the geko™ device on patient outcomes in critically ill COVID-19 patients.
From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.
Morbidity
Time Frame: From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.
The impact of the geko™ device on patient outcomes in critically ill COVID-19 patients.
From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Tina Mele, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2022

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS-COV-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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