NCT04699227

Can RIC Prevent Deterioration to Critical Care in Covid19

Completed NA Last updated 29 November 2023

What this trial tests

NA trial testing Cuff application with inflation in Covid19 in 40 participants. Completed in 31 October 2021.

Timeline

15 January 2021

Primary endpoint
31 August 2021

31 October 2021

Quick facts

Lead sponsor	Derek Yellon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	15 January 2021
Primary completion	31 August 2021
Estimated completion	31 October 2021
Sites	4 locations across South Africa, United Kingdom, Brazil

Drugs / interventions tested

• Cuff application with inflation
• Sham inflation

Conditions studied

• Covid19 — all drugs for Covid19 →
• Ischemia — all drugs for Ischemia →

Sponsor

Derek Yellon

Who can join

Adults 18 to 80, any sex, with Covid19 or Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phenotypic changes in low-density lipoprotein particles as markers of adverse clinical outcomes in COVID-19.
   Carmo HRP, Yoshinaga MY, Castillo AR, Britto Chaves-Filho A, et al · · 2023 · cited 9× · PMID 36889041 · DOI 10.1016/j.ymgme.2023.107552
2. 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.
   Davidson SM, Lukhna K, Gorog DA, Salama AD, et al · · 2022 · cited 3× · PMID 34169381 · DOI 10.1007/s10557-021-07221-y
3. Effect of Remote Ischaemic Conditioning on the Inflammatory Cytokine Cascade of COVID-19 (RIC in COVID-19): a Randomized Controlled Trial.
   Lukhna K, do Carmo HRP, Castillo AR, Davidson SM, et al · · 2024 · cited 2× · PMID 36445625 · DOI 10.1007/s10557-022-07411-2