Covid19CAGENCT04651374
COVID-19 And Geko Evaluation: The CAGE Study
A study testing geko T3 in people with Covid19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- geko T3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2022to 8 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who test positive for Covid-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- geko T3
- Keywords
- ICU, Covid 19, C19, Coronavirus, geko, Deep venous thrombosis, DVT
- Medical subject headings
- COVID-19, Coronavirus Infections, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko T3Device
Also called NMES
The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Geko Device | Experimental | Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria
Measured: Within a two year period
Safety of device: AE
We will measure the rate of adverse events, primarily local site irritation or discomfort
Measured: 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
Measured: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
Secondary outcomes (2)
Mortality
The impact of the geko™ device on patient outcomes in critically ill COVID-19 patients.
Measured: From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.
Morbidity
The impact of the geko™ device on patient outcomes in critically ill COVID-19 patients.
Measured: From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startApr 2022 (estimated)
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: Study site was unable to proceed with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial of 20 participants in each arm.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tina Mele, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651374
- Sponsor's protocol ID
- ISS-COV-002
- Acronym
- CAGE
- Status last verified
- Oct 2023
- First submitted
- 27 Nov 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 And Geko Evaluation: The CAGE Study
- ClinicalTrials.gov ID
- NCT04651374
- Acronym / sponsor ID
- CAGE / ISS-COV-002
- Conditions
- Covid19
- Keywords
- ICU, Covid 19, C19, Coronavirus, geko, Deep venous thrombosis, DVT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study site was unable to proceed with recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial of 20 participants in each arm.
| Arm | Type | Receives |
|---|---|---|
| Geko Device | Experimental | Device: geko T3Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm. |
| No Device | No intervention | –Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who test positive for Covid-19
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geko T3Also: NMESThe device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours. | Device | Geko Device |
Primary outcome
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
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
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
2 secondary outcomes
Mortality
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Covid19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Mele principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko T3 in people with Covid19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Within a two year period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.