COVIDNCT04659460
RIC as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study
A study testing Remote Ischemic Conditioning in people with COVID and Corona Virus Infection, run by Unity Health Toronto.
Trial summary
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID, Corona Virus Infection, Acute Lung Injury
- What is being tested?
- Remote Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 1 Sep 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 16 years old
- Admission to ICU
- Either confirmed positive, or presumed, COVID-19 disease
- Radiological evidence of COVID-related pneumonia (CXR or CT abnormalities indicating COVID-19 pneumonia; such as, ground-glass opacities)
- Able to safely undergo conditioning of the arm
- No peripheral vascular disease
Show all 9Show fewer
- No evidence of prior arm surgery
- No evidence of prior radiation or lymph node dissection
- Clinical staff deems it safe to proceed (Yes/No: signed by MRP)
Who cannot join
- Age <16 years
- Unable to safely undergo conditioning
- Known peripheral vascular disease
- Evidence of prior arm surgery
- Evidence of prior radiation or lymph node dissection
- Clinical staff deems it unsafe (Yes/No: signed by MRP)
Show all 9Show fewer
- No radiological evidence of COVID-related pneumonia
- Hemodynamically unstable: Patients with SBP 90 or SBP 180 excluded until hemodynamically stabilized, then reassessed for inclusion
- Anti-coagulation drug use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Remote Ischemic Conditioning as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
Read the detailed description
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL-1 and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
Remote ischemic conditioning (RIC) is an experimental and non-invasive procedure that utilizes the body's natural defense against ischemia-reperfusion (IR) injury, which is believed to stimulate innate multiorgan protection against various systemic immunopathological processes. Although its mechanisms are not entirely understood, favorable outcomes have been demonstrated in multiple remote organs including the heart, kidneys, liver, and lungs. It consists of brief and repeated doses of non-lethal ischemia and reperfusion to a limb using a tourniquet, which is thought to modulate systemic inflammation by altering several inflammatory signaling pathways.
Studies have demonstrated suppression of genes encoding proteins involved in leukocyte chemotaxis, adhesion, migration, and exocytosis, as well as innate immunity responses, cytokine synthesis, and upregulation of anti-inflammatory genes. Multiple human and animal studies have demonstrated its efficacy in decreasing inflammatory biomarkers such as IL-6, CRP, IL-1B, and TNF; inflammatory mediators correlated with increasing COVID-19 disease severity. With regards to safety, currently, over 10,000 patients worldwide have completed clinical trials involving RIC, and another 20,000 are enrolled in ongoing trials. RIC presents few risks in otherwise healthy patients. Theoretical risks are highest in those patients with risk factors for vascular compromise: previous vascular surgery, vascular trauma, or known vascular disease. Excluding such patients, the practise of RIC appears to be safe in human studies This clinical trial will be enrolling 30 COVID-19+, or presumed COVID-19+ ICU patients at St. Michael's Hospital in Toronto, Canada. Eligible patients with severe COVID-19 disease will be randomized to undergo RIC versus sham-RIC. RIC interventions will be applied to one of the extremities calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg. All interventions will be performed within 6 hours upon ICU admission of a confirmed or suspected COVID+ patient, given that the patient is determined eligible and their physician deems it safe to enroll. The RIC procedure will be performed every 72 hours upon randomization, +/- 1 hour to accommodate caveats in performing the procedure at that time. Blood will be collected at various timepoints to assess RIC on biomarkers of inflammation and coagulation, and clinical metrics such as need for ventilation, LOS, presentation, and timing of symptoms will be tracked. Patients not in legal capacity and when an SDM cannot be identified or contacted will be enrolled on a deferred consent basis, and provided the option of withdrawing their study data should they regain capacity.
With the current and evolving COVID-19 pandemic, ICU's are at risk of becoming overwhelmed; thus, there exists a need for a safe, rapid, and effective treatment. RIC is known to be a safe procedure that may have the potential to attenuate systemic immunopathological processes implicated in severe COVID-19 disease. If shown to be effective, it may help ameliorate the need for extensive and costly care in the ICU setting. It can theoretically be performed with any tourniquet-like device, which may be useful in a wide range of settings. Lastly, knowledge gained from this research may have the potential to inspire further work into the use of RIC in related conditions, such as viral pneumonia or sepsis.
- Conditions
- COVID, Corona Virus Infection, Acute Lung Injury, Ischemia Limb, Acute Respiratory Distress Syndrome
- Being tested
- Remote Ischemic Conditioning
- Keywords
- Remote Ischemic Conditioning, Inflammatory response
- Medical subject headings
- Coronavirus Infections, Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningDevice
RIC interventions will be applied to the upper extremity calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | RIC interventions will be applied to the upper extremity for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg. Receives: Device: Remote Ischemic Conditioning |
| Sham Remote Ischemic Conditioning | Sham comparator | RIC sham interventions will be applied to the upper extremity for a total of 20 cumulative minutes. For sham, inflation will occur. Receives: Device: Remote Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 1-Beta (IL-1B) (pg/mL)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Interleukin 6 (IL-6) (pg/mL)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
C-reactive protein (CRP) (mg/mL)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Tumour Necrosis Factor Alpha (TNFa) (pg/mL)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Neutrophil to Lymphocyte Ratio (NLR) (absolute neutrophils/lymphocytes)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Serum Ferritin (ng/mL)
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
International Normalized Ratio (INR)
Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Prothrombin Time (PTT)
Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measured: Through study completion - up to 12 months
Rotational Thromboelastometry (ROTEM)
ROTEM coagulation assessment using the commercial ROTEM device traditionally used for the assessment of coagulopathy, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point).
Measured: Through study completion - up to 12 months
Secondary outcomes (3)
Total duration of mechanical ventilation (number of days)
Number of continuous calendar days or partial calendar days including treatment with invasive ventilation.
Measured: Through study completion - up to 12 months
Intensive Care Unit Length of Stay (number of days)
Number of continuous calendar days or partial calendar days admitted to an acute care hospital.
Measured: Through study completion - up to 12 months
Hospital Length of Stay (number of days)
Number of continuous calendar days or partial calendar days admitted to an acute care hospital.
Measured: Through study completion - up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Single-centre, randomized controlled pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Defence Research and Development Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659460
- Sponsor's protocol ID
- 1.4
- Status last verified
- Dec 2020
- First submitted
- 3 Jul 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the knowledge on RIC in severe COVID-19 patients is refined, tested, and interpreted through statistical analysis, the data will be published in a peer-reviewed journal. If deemed effective, the contextualization and adaptation may prompt a multi-center trial headed by St. Michael's Hospital to further support data. This would allow further evaluation and later implementation of the intervention with the help of the Knowledge Translation (KT) team at the Li Ka Shing Research Institute.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04659460
- Acronym / sponsor ID
- 1.4
- Conditions
- COVID, Corona Virus Infection, Acute Lung Injury, Ischemia Limb, Acute Respiratory Distress Syndrome
- Keywords
- Remote Ischemic Conditioning, Inflammatory response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Defence Research and Development Canada
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 9 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.
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
Detailed description
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL-1 and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
Remote ischemic conditioning (RIC) is an experimental and non-invasive procedure that utilizes the body's natural defense against ischemia-reperfusion (IR) injury, which is believed to stimulate innate multiorgan protection against various systemic immunopathological processes. Although its mechanisms are not entirely understood, favorable outcomes have been demonstrated in multiple remote organs including the heart, kidneys, liver, and lungs. It consists of brief and repeated doses of non-lethal ischemia and reperfusion to a limb using a tourniquet, which is thought to modulate systemic inflammation by altering several inflammatory signaling pathways.
Studies have demonstrated suppression of genes encoding proteins involved in leukocyte chemotaxis, adhesion, migration, and exocytosis, as well as innate immunity responses, cytokine synthesis, and upregulation of anti-inflammatory genes. Multiple human and animal studies have demonstrated its efficacy in decreasing inflammatory biomarkers such as IL-6, CRP, IL-1B, and TNF; inflammatory mediators correlated with increasing COVID-19 disease severity. With regards to safety, currently, over 10,000 patients worldwide have completed clinical trials involving RIC, and another 20,000 are enrolled in ongoing trials. RIC presents few risks in otherwise healthy patients. Theoretical risks are highest in those patients with risk factors for vascular compromise: previous vascular surgery, vascular trauma, or known vascular disease. Excluding such patients, the practise of RIC appears to be safe in human studies This clinical trial will be enrolling 30 COVID-19+, or presumed COVID-19+ ICU patients at St. Michael's Hospital in Toronto, Canada. Eligible patients with severe COVID-19 disease will be randomized to undergo RIC versus sham-RIC. RIC interventions will be applied to one of the extremities calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg. All interventions will be performed within 6 hours upon ICU admission of a confirmed or suspected COVID+ patient, given that the patient is determined eligible and their physician deems it safe to enroll. The RIC procedure will be performed every 72 hours upon randomization, +/- 1 hour to accommodate caveats in performing the procedure at that time. Blood will be collected at various timepoints to assess RIC on biomarkers of inflammation and coagulation, and clinical metrics such as need for ventilation, LOS, presentation, and timing of symptoms will be tracked. Patients not in legal capacity and when an SDM cannot be identified or contacted will be enrolled on a deferred consent basis, and provided the option of withdrawing their study data should they regain capacity.
With the current and evolving COVID-19 pandemic, ICU's are at risk of becoming overwhelmed; thus, there exists a need for a safe, rapid, and effective treatment. RIC is known to be a safe procedure that may have the potential to attenuate systemic immunopathological processes implicated in severe COVID-19 disease. If shown to be effective, it may help ameliorate the need for extensive and costly care in the ICU setting. It can theoretically be performed with any tourniquet-like device, which may be useful in a wide range of settings. Lastly, knowledge gained from this research may have the potential to inspire further work into the use of RIC in related conditions, such as viral pneumonia or sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | Device: Remote Ischemic ConditioningRIC interventions will be applied to the upper extremity for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg. |
| Sham Remote Ischemic Conditioning | Sham comparator | Device: Remote Ischemic ConditioningRIC sham interventions will be applied to the upper extremity for a total of 20 cumulative minutes. For sham, inflation will occur. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 16 years old
- Admission to ICU
- Either confirmed positive, or presumed, COVID-19 disease
- Radiological evidence of COVID-related pneumonia (CXR or CT abnormalities indicating COVID-19 pneumonia; such as, ground-glass opacities)
- Able to safely undergo conditioning of the arm
Key exclusion criteria (9 listed)
- Age <16 years
- Unable to safely undergo conditioning
- Known peripheral vascular disease
- Evidence of prior arm surgery
- Evidence of prior radiation or lymph node dissection
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 |
|---|---|---|
| Remote Ischemic ConditioningRIC interventions will be applied to the upper extremity calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg. | Device | Remote Ischemic Conditioning, Sham Remote Ischemic Conditioning |
Primary outcome
Interleukin 1-Beta (IL-1B) (pg/mL)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Interleukin 6 (IL-6) (pg/mL)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
C-reactive protein (CRP) (mg/mL)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Tumour Necrosis Factor Alpha (TNFa) (pg/mL)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Neutrophil to Lymphocyte Ratio (NLR) (absolute neutrophils/lymphocytes)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Serum Ferritin (ng/mL)
Time frame: Through study completion - up to 12 months
Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
International Normalized Ratio (INR)
Time frame: Through study completion - up to 12 months
Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Prothrombin Time (PTT)
Time frame: Through study completion - up to 12 months
Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Rotational Thromboelastometry (ROTEM)
Time frame: Through study completion - up to 12 months
ROTEM coagulation assessment using the commercial ROTEM device traditionally used for the assessment of coagulopathy, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point).
3 secondary outcomes
Total duration of mechanical ventilation (number of days)
Time frame: Through study completion - up to 12 months
Intensive Care Unit Length of Stay (number of days)
Time frame: Through study completion - up to 12 months
Hospital Length of Stay (number of days)
Time frame: Through study completion - up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: No. Once the knowledge on RIC in severe COVID-19 patients is refined, tested, and interpreted through statistical analysis, the data will be published in a peer-reviewed journal. If deemed effective, the contextualization and adaptation may prompt a multi-center trial headed by St. Michael's Hospital to further support data. This would allow further evaluation and later implementation of the intervention with the help of the Knowledge Translation (KT) team at the Li Ka Shing Research Institute.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning in people with COVID and Corona Virus Infection, run by Unity Health Toronto.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Trpcic (4168646060 ext. 7131, Sandy.Trpcic@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 1-Beta (IL-1B) (pg/mL) (time frame: Through study completion - up to 12 months). The study lists 9 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 9 Dec 2020.