Inhibition of bradykinin in SARS-CoV-2 infection: a randomised, double-blind trial of icatibant compared with placebo (ICASARS)

What Was Tested

This clinical study looks at Bradykinin and Icatibant.

Retinal imaging will be performed to assess vessel size.

Why It Was Studied

SARS-CoV-2 binds to ACE2 receptors and enters cells.

The symptoms are cough, breathlessness, loss of taste/smell and X-ray evidence of infiltrates on chest imaging initially caused by oedema, and subsequently by a lymphocytic pneumonitis.

Who Took Part

In this study, hypoxic patients with COVID-19 with symptom onset ≤7 days will be randomised to either a bradykinin inhibitor (icatibant) or placebo.

Patients and investigators will be blinded.

How the Study Was Run

The researchers set it up as a randomized and placebo-controlled study.

The participants were allocated by chance, so the Bradykinin group and the comparison group should start out alike.

The comparison arm used a placebo, so changes seen with Bradykinin could be set against what happens without it.

The primary outcome will be blood oxygenation, measured by arterial blood sampling.

The secondary outcome will be cardiovascular status.

Blood samples will be taken for measurement of inflammatory analyses including IL-6.

As a separate substudy, the researchers will also take comparator blood inflammatory samples from a COVID-19-negative cohort.

What Was Measured

Topics PubMed links to this paper include Bradykinin, Cough, COVID-19, Edema, Hypotension, Interleukin-6 and SARS-CoV-2.

Author keywords: RESPIRATORY MEDICINE (see Thoracic Medicine) and VIROLOGY.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Bradykinin and Icatibant.

The publication is from 2023 (BMJ open), a journal based in England.

More context: the Bradykinin compound page and the Icatibant compound page, all human trials.