Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

What Was Tested

In this phase 2 trial, researchers set out to test Icatibant.

It had three arms (groups): standard care + C1 inhibitor (experimental), standard care + Icatibant + C1 inhibitor (experimental) and standard care + placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

The maximum duration of patient participation in the study will be 10 days.

Who Took Part

The registry lists 44 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient over 18 years of age, having read and signed the consent form for participation in the study after the reflection period (≤ 15 minutes). Patient screened for COVID+ by RT-PCR on nasopharyngeal swab. Patient with at least three of the following respiratory signs:. Temperature \>38° C. Non-productive dry cough.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: patient with pre-existing respiratory disease (cancer, copd, asthma, emphysema) or smoking history of \> 25 years); patient with a known allergy to one of the study products; patient treated with anti tnf, il1 or il6.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Icatibant study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Icatibant study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-02-04 with completion listed for 2021-06-13.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Tolerance evaluation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Icatibant in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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