Icatibant in SARS-CoV 2 (ICASARS)
Research type
Research Study
Full title
Inhibition of Bradykinin in SARS-CoV-2 infection with Icatibant (ICASARS)
IRAS ID
301118
Contact name
Joe Kidney
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Eudract number
2021-005851-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
In a normal reaction to a wound, such as after surgery, there is stimulation of pain nerves (called c-fibres), swelling and clotting. When people are hospitalized with COVID-19 they usually have a cough (lung c-fibre stimulation), swelling in the lung and clotting.
Bradykinin is a type of chemical that is released in response to inflammation. It causes C-fibre stimulation, dilation of vessels with oedema (swelling), lowered blood pressure and release of inflammatory chemicals (cytokines).
Normally the production of bradykinin is carefully balanced in the body. Some people have a tendency to release bradykinin. This results in spontaneous swelling - it is called hereditary angioedema (HAE).
There has been a treatment for HAE which has been in use since 2008. It is a medication called Icatibant. This blocks the effect of bradykinin at one of its receptors. It is given by injection under the skin.
We will identify people attending hospital with low oxygen levels caused by COVID 19. They will be invited to participate in the trial. Participants will be randomly allocated into one of two groups. One group will be given the study drug, Icatibant. The other group will be given a placebo injection containing saline water. The main aim of the study is to see if treatment with Icatibant will improve blood oxygen levels.
In addition, we will measure blood pressure and heart rate response to treatment. We will assess the blood vessels at the back of the eye. Blood samples will be taken for measurement of an inflammatory protein (IL-6) and part of the sample will be stored for future use. We will also take blood from a group of control participants who do not have Covid-19 infection. The control blood samples will be analysed for IL-6 and part will also be stored for future use.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0014
Date of REC Opinion
15 Feb 2022
REC opinion
Further Information Favourable Opinion