Covid19 Clinical Trial
Official title:
CAN REMOTE ISCHAEMIC CONDITIONING REDUCE INFLAMMATORY MARKERS IN COVID-19 PATIENTS - A MULTI-SITE, RANDOMISED PILOT STUDY
Verified date | November 2023 |
Source | University College London Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The coronavirus disease (COVID-19) emerged in late 2019 and has since been diagnosed in over a million persons worldwide. As this virus progresses, it causes an extreme and uncontrolled response from the patient's immune system accompanied by reduced oxygen flow to major organs, and subsequent ischaemic injury. The current treatment of COVID-19 is largely supportive without any cure or vaccine available at this time. Developing new methods to reduce this heightened inflammatory response is essential to halting progression of COVID-19 in patients and reducing the severity of damage. The cellular mechanisms seen in COVID-19 are similar to those seen in patients with sepsis. A process known as Remote Ischemic Conditioning (RIC) is an intervention which has been shown to prevent cellular injury including those associated with sepsis. Based on the evidence from studies looking at sepsis, it is anticipated the same benefit would be seen in patients diagnosed with COVID-19. RIC is a simple, non-invasive procedure where a blood pressure cuff is applied to the arm for repeated cycles of inflating and deflating (typically 3-5 cycles of 5 minutes each). This process activates pro-survival mechanisms in the body to protect vital organs and improve the immune system. Therefore, we believe it represents an exciting strategy to protect organs against reduced blood flow and extreme immune response, as seen in COVID-19 infections. This study has already been fully approved
Status | Completed |
Enrollment | 40 |
Est. completion date | October 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult patients (aged 18 - 80 yrs) with diagnosed COVID-19. Exclusion Criteria: - Contraindication for the use of a brachial cuff on either arm. - Intercurrent disease with an expected life expectancy of less than 24 h, cardiac arrest, - Pregnant or breastfeeding women. - Bleeding disorder or platelet count below 50. - Currently enrolled in another research study |
Country | Name | City | State |
---|---|---|---|
Brazil | Atherosclerosis and Vascular Biology laboratory, State University of Campinas | Campinas | |
South Africa | Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town | Cape Town | |
United Kingdom | Royal Free London NHS Foundation Trust, | London | |
United Kingdom | East and North Hertfordshire NHS TrusEast and North Hertfordshire NHS Trus | Stevenage |
Lead Sponsor | Collaborator |
---|---|
Derek Yellon |
Brazil, South Africa, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Endpoint | The primary outcome is to demonstrate that remote ischaemic conditioning reduces the severity of inflammatory cytokine release which are responsible for the cytokine "storm" that occurs in following COVID-19 infection. The endpoint is area under the curve of inflammatory markers and cardiac biomarkers. |
12 months | |
Secondary | Secondary Endpoint | Secondary endpoint will be the need for intensive care admission or death. | 12 months |
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