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

August 2, 2022 updated by: Sebastian Videla

Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2 (COVID-19) Without Assisted Ventilation Compared With Standard Care

To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • L'Hospitalet De Llobregat, Catalonia, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. adult patients (18 years or older), both sexes
  2. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
  3. hospitalized with a diagnosis of SARS-CoV-2 pneumonia
  4. radiographic evidence of pulmonary infiltrates
  5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
  6. pO2/FiO2 <380
  7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
  8. obtaining the informed consent of the patient or the legal representative.

Exclusion Criteria:

  1. imminent death (life expectancy less than 72h)
  2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
  3. invasive mechanical ventilation
  4. participation in any other clinical trial
  5. ALT or AST > 5 x ULN
  6. creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants '18 years old [Cockcroft 1976]
  7. patients with recent acute coronary syndrome (<1 month)
  8. patients with a history of stroke
  9. positive pregnancy test
  10. pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (SoC)
Other: SoC
The SoC could include respiratory support measures, fluid therapy, antipyretic treatment, postural measures, low-molecular-weight-heparins, corticosteroids, such as dexamethasone, remdesivir and other therapeutic options
Experimental: SoC + Icatibant
Other: SoC
The SoC could include respiratory support measures, fluid therapy, antipyretic treatment, postural measures, low-molecular-weight-heparins, corticosteroids, such as dexamethasone, remdesivir and other therapeutic options
Drug: Firazyr
Icatibant 10 MG/ML Prefilled Syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of experimental treatment
Time Frame: up to 10 days
Number of patients reaching grade 2 (inpatient, no longer requiring supplemental oxygen and no longer requiring care or grade 1 (hospital discharge) of the ordinal scale of the clinical state of the patient for 48 hours.
up to 10 days
Safety of experimental treatment
Time Frame: up to 10 days
Number of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE).
up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term efficacy
Time Frame: up to 10 days
Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment.
up to 10 days
Time to achive a clinical response
Time Frame: up to 40 days
period time (days) between visit 1 (treatment start visit) and the day of gathering sustained 48-hour grade 2, grade 1 or grade 0 classification on the WHO 8-point ordinal scale for clinical status assessment The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19
up to 40 days
Time to achive an afebrile state
Time Frame: up to 40 days
period time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication.
up to 40 days
time from symptom onset to treatment
Time Frame: up to day 1
period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
up to day 1
Responders
Time Frame: up to 40 days
Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
up to 40 days
COVID-19 related relapse
Time Frame: up to 40 days
number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
up to 40 days
Patients with Adverse Events
Time Frame: up to 40 days
number of patients with Any Adverse Events
up to 40 days
Adverse Events
Time Frame: up to 40 days
Number of Adverse Events
up to 40 days
Serious Adverse Events
Time Frame: up to 40 days
Number of Serious Adverse Events
up to 40 days
Overall mortality
Time Frame: up to 40 days
number of patients who died
up to 40 days
COVID-19 related mortality
Time Frame: up to 40 days
number of patients who died due to COVID-19
up to 40 days
Time until death
Time Frame: up to 40 days
number of days from visit 1 until death
up to 40 days
COVID-19-related complications
Time Frame: up to 40 days
number of patients who had any COVID-19 related complications
up to 40 days
Patients requiring intensive care
Time Frame: up to 40 days
number of patients who require intensive care
up to 40 days
patients requiring intensive care and invasive mechanical ventilation
Time Frame: up to 40 days
number of patients who require intensive care and invasive mechanical ventilation
up to 40 days
patients requiring oxygen supplementation
Time Frame: up to 40 days
number of patients who require oxygen supplementation from hospital discharge up until visit 7
up to 40 days
Patients with nonsocomial infection
Time Frame: up to 40 days
number (and percentage) of patients diagnosed with another nosocomial infection
up to 40 days
Rehospitalizations
Time Frame: up to 40 days
number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge
up to 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebastian Videla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

March 17, 2022

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB-MdI-ICAT·COVID-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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