Can RIC Prevent Deterioration to Critical Care in Covid19

NCT04699227 | Completed

• 1 other identifier: 20/SC/0192
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Covid19; Ischemia

Keywords

Covid19; Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Endpoint

  12 months

Study Arms (2)

Control group not receiving RIC

SHAM COMPARATOR

Those randomised to the control group will have the blood pressure cuff placed on the arm, but it will not be inflated.

Other: Sham inflation

Interventional group receiving RIC

EXPERIMENTAL

RIC will consist of 3-4 cycles of cuff inflations to 200 mmHg for 5 min with deflation to 0 mmHg for another 5 min, which is automatically administered by the pre-programmed cuff.

Procedure: Cuff application with inflation

Interventions

Cuff application with inflation PROCEDURE

The blood pressure cuff will be placed on the arm and inflated.

Interventional group receiving RIC

Sham inflation OTHER

The blood pressure cuff will be placed on the arm and not inflated.

Control group not receiving RIC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients (aged 18 - 80 yrs) with diagnosed COVID-19.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derek Yellon: lead

Study Sites (4)

Atherosclerosis and Vascular Biology laboratory, State University of Campinas

Campinas, Brazil

Location

Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town

Cape Town, South Africa

Location

Royal Free London NHS Foundation Trust,

London, NW3 2QG, United Kingdom

Location

East and North Hertfordshire NHS TrusEast and North Hertfordshire NHS Trus

Stevenage, SG1 4AB, United Kingdom

Location

Related Publications (2)

• Lukhna K, do Carmo HRP, Castillo AR, Davidson SM, Geffen H, Giesz S, Golforoush P, Bovi TG, Gorag D, Salama A, Imamdin A, Kalkhoran S, Lecour S, Perroud MW Jr, Ntsekhe M, Sposito AC, Yellon DM. Effect of Remote Ischaemic Conditioning on the Inflammatory Cytokine Cascade of COVID-19 (RIC in COVID-19): a Randomized Controlled Trial. Cardiovasc Drugs Ther. 2024 Jun;38(3):433-445. doi: 10.1007/s10557-022-07411-2. Epub 2022 Nov 29.

  PMID: 36445625 DERIVED

• Davidson SM, Lukhna K, Gorog DA, Salama AD, Castillo AR, Giesz S, Golforoush P, Kalkhoran SB, Lecour S, Imamdin A, do Carmo HRP, Bovi TG, Perroud MW Jr, Ntsekhe M, Sposito AC, Yellon DM. RIC in COVID-19-a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19. Cardiovasc Drugs Ther. 2022 Oct;36(5):925-930. doi: 10.1007/s10557-021-07221-y. Epub 2021 Jun 25.

  PMID: 34169381 DERIVED

MeSH Terms

Conditions

COVID-19; Ischemia

Interventions

Inflation, Economic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: January 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); GB (2); ZA (1)