COVID-19 And Geko Evaluation: The CAGE Study

Covid19 Clinical Trial

— CAGE  

Official title:

COVID-19 And Geko Evaluation: The CAGE Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04651374
• Other study ID #: ISS-COV-002
• Status: Withdrawn
• Phase: N/A
• Start date: April 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria	Within a two year period
Primary	Safety of device: AE	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.
Primary	Protocol Adherence	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	Mortality	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.
Secondary	Morbidity	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.