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

Sponsor

Sebastian Videla (Other)

Overall Status

Completed

CT.gov ID

NCT04978051

Collaborator

(none)

Enrollment

Location

Arms

11.1

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Drug: Firazyr Other: SoC	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 12, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Mar 17, 2022

Arms and Interventions

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	Drug: Firazyr Icatibant 10 MG/ML Prefilled Syringe 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

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

Drug: Firazyr

Icatibant 10 MG/ML Prefilled Syringe

Other: SoC

Outcome Measures

Primary Outcome Measures

Efficacy of experimental treatment [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.
Safety of experimental treatment [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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
pO2/FiO2 <380
men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
obtaining the informed consent of the patient or the legal representative.

Exclusion Criteria:

imminent death (life expectancy less than 72h)
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
ALT or AST > 5 x ULN
creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants '18 years old [Cockcroft 1976]
patients with recent acute coronary syndrome (<1 month)
patients with a history of stroke
positive pregnancy test
pregnant or lactating woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Catalonia	Spain	08907

Sponsors and Collaborators

Sebastian Videla

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Sebastian Videla, Head of the Clinical Research Support Unit, Hospital Universitari de Bellvitge

ClinicalTrials.gov Identifier:

NCT04978051

Other Study ID Numbers:

HUB-MdI-ICAT·COVID-201

First Posted:

Jul 27, 2021

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sebastian Videla, Head of the Clinical Research Support Unit, Hospital Universitari de Bellvitge

icatibant

Additional relevant MeSH terms:

COVID-19

Icatibant

Study Results

No Results Posted as of Aug 3, 2022