Inhibition of Bradykinin in COVID-19 Infection With Icatibant

What Was Tested

This registered phase 2, phase 3 trial tested Icatibant.

There is excess accumulation of bradykinin during symptomatic SARS CoV-2 lung infection.

It also causes vasodilation, hypotension and cytokine release.

It had two arms (groups): Icatibant and Standard of care (SOC) (active comparator) and one (placebo comparator).

Icatibant will be given as a single, subcutaneous injection.

Placebo will be given as a single, subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

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 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 cytokines.

Who Took Part

Enrollment: 32 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: Age \>18 years. Documented evidence of COVID-19 and symptom onset of 7 days or less.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients known to be pregnant or breastfeeding; patients with unstable ischaemic heart disease or acute stroke; patients enrolled in other clinical trials of an investigational medicine within the previous 28 day period.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Icatibant, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-05-16 with completion listed for 2023-06-09.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Oxygenation (time frame: Baseline and 3 hours after study drug administration).

It also tracked 3 secondary outcomes, for example Change in Blood pressure, Change in mean arterial pressure (MAP) and Change in heart rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Icatibant in 32 people.

Its size is small, so on its own it can only give an early look.

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.