Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial

What Was Tested

The paper reports a study of Bradykinin and Icatibant, published as a clinical study.

SARS-CoV-2, the virus that causes COVID-19, enters the cells through a mechanism dependent on its binding to angiotensin-converting enzyme 2 (ACE2), a protein highly expressed in the lungs.

The putative viral-induced inhibition of ACE2 could result in the defective degradation of bradykinin, a potent inflammatory substance.

Who Took Part

By PubMed's age tags, the people studied were adults.

How the Study Was Run

The researchers set it up as a randomized, open-label and parallel-group study.

Random assignment meant chance, not the researchers, decided who got Bradykinin and who got the comparison, which limits bias.

Everyone knew when Bradykinin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The Bradykinin group and the comparison group ran side by side rather than switching.

What Was Measured

Topics PubMed links to this paper include Angiotensin-Converting Enzyme 2, Bradykinin, Bradykinin B2 Receptor Antagonists, Brazil, COVID-19, Clinical Trials, Phase II as Topic and Complement C1 Inhibitor Protein.

Author keywords: ACE2, C1 esterase inhibitor, Icatibant and Pneumonia.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Bradykinin and Icatibant.

The abstract goes on to report its results in about 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Trials), a journal based in England.

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