Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection

What Was Tested

The trial (phase 2) is built around Icatibant.

It had two arms (groups): Standard of Care (SoC) (active comparator) and SoC + Icatibant (experimental).

The registry classes the interventions as drug and other.

Who Took Part

73 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: Adult patients (18 years or older), both sexes. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization. Hospitalized with a diagnosis of SARS-CoV-2 pneumonia. Radiographic evidence of pulmonary infiltrates. Grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation; invasive mechanical ventilation; participation in any other clinical trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2021-04-12 with completion listed for 2021-11-30.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Safety of experimental treatment (time frame: up to 10 days).

It also tracked 18 secondary outcomes, for example Time to achive a clinical response, Time to achive an afebrile state, time from symptom onset to treatment, Responders, COVID-19 related relapse and Patients with Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Icatibant in 73 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.