COVID-19 And Geko Evaluation: The CAGE Study

NCT04651374 | Withdrawn

• 1 other identifier: ISS-COV-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

ICU; Covid 19; C19; Coronavirus; geko; Deep venous thrombosis; DVT

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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 Outcomes (2)

• Mortality

  From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.

• Morbidity

  From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.

Study Arms (2)

Geko Device

EXPERIMENTAL

Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

Device: geko T3

No Device

NO INTERVENTION

Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

Interventions

geko T3 DEVICE

The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.

Also known as: NMES

Geko Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who test positive for Covid-19

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Venous Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tina Mele

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial of 20 participants in each arm.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 3, 2020
• Study Start: April 1, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)