COVID-19 And Geko Evaluation: The CAGE Study

Not Applicable

Withdrawn

• Conditions: Covid19
• Interventions: Device: geko T3

• Registration Number: NCT04651374
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

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 Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2022-04
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geko Device	geko T3	Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

Primary Outcome Measures

Name	Time	Method
Protocol Adherence	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
Feasibility of recruitment	Within a two year period	Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria
Safety of device: AE	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

Secondary Outcome Measures

Name	Time	Method
Mortality	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.
Morbidity	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.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada