Clinical trial NCT04651374: COVID-19 And Geko Evaluation: The CAGE Study
Official title: COVID-19 And Geko Evaluation: The CAGE Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Keywords: ICU
Covid 19
C19
Coronavirus
geko
Deep venous thrombosis
DVT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial of 20 participants in each arm.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Within a two year period
measure: Safety of device: AE
timeFrame: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
measure: Protocol Adherence
timeFrame: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
Secondary outcomes:
measure: Mortality
timeFrame: From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.
measure: Morbidity
timeFrame: From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Tina Mele
role: PRINCIPAL_INVESTIGATOR
References: