A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)

Plain-language guide to PMID 35413921 (2022): randomized and open-label clinical study of Bradykinin and Icatibant in 120 patients.

Key Facts

PMID: 35413921
Journal: Trials
Year: 2022
Study type: Clinical Study
Authors: Malchair P et al. (10 authors)
DOI: 10.1186/s13063-022-06219-7

What This Study Did, in Plain Language

What Was Tested

This clinical study looks at Bradykinin and Icatibant.

Who Took Part

According to the abstract, 120 patients were involved.

Patients hospitalized with a confirmed COVID-19 pneumonia diagnosis (RT-PCR or antigen test ≤ 10 days prior to randomization, and radiographic evidence of pulmonary infiltrates), rated "4" or "5" on the WHO's clinical status scale, are eligible.

Patients will be randomized on a 1:1 ratio to either standard of care-plus-icatibant (experimental group) or to standard of care alone (control group).

How the Study Was Run

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

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

Being open-label, the Bradykinin study did not mask who received what.

Running at several centres spread the Bradykinin study over different clinics and patient groups.

The expected sample size is 120 patients (60 per group) from 2 sites in Spain.

What Was Measured

PubMed files the paper under topics including Bradykinin, COVID-19, Clinical Trials, Phase II as Topic, Endothelial Cells, Hospital Units, Neoplasm Recurrence, Local and Randomized Controlled Trials as Topic.

The authors tagged it with the keywords ACE2, ARDS, Icatibant, SARS and SARS-CoV-2.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Bradykinin and Icatibant in 120 patients.

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2022 (Trials), a journal based in England.

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

Our Notes on the Compounds

Bradykinin: A 9-amino-acid peptide that widens blood vessels and causes swelling; given in research studies of blood flow.

Icatibant: A synthetic 10-amino-acid peptide that blocks the bradykinin B2 receptor; sold as Firazyr for hereditary angioedema attacks.

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.