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

Primary Purpose

COVID-19 Pneumonia

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Firazyr
SoC
Sponsored by
Sebastian Videla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring icatibant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care (SoC)

SoC + Icatibant

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of experimental treatment
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
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
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
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
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
period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
Responders
Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
COVID-19 related relapse
number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
Patients with Adverse Events
number of patients with Any Adverse Events
Adverse Events
Number of Adverse Events
Serious Adverse Events
Number of Serious Adverse Events
Overall mortality
number of patients who died
COVID-19 related mortality
number of patients who died due to COVID-19
Time until death
number of days from visit 1 until death
COVID-19-related complications
number of patients who had any COVID-19 related complications
Patients requiring intensive care
number of patients who require intensive care
patients requiring intensive care and invasive mechanical ventilation
number of patients who require intensive care and invasive mechanical ventilation
patients requiring oxygen supplementation
number of patients who require oxygen supplementation from hospital discharge up until visit 7
Patients with nonsocomial infection
number (and percentage) of patients diagnosed with another nosocomial infection
Rehospitalizations
number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge

Full Information

First Posted
June 30, 2021
Last Updated
August 2, 2022
Sponsor
Sebastian Videla
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1. Study Identification

Unique Protocol Identification Number
NCT04978051
Brief Title
Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection
Acronym
ICAT·COVID
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sebastian Videla

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
icatibant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SoC)
Arm Type
Active Comparator
Arm Title
SoC + Icatibant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Firazyr
Intervention Description
Icatibant 10 MG/ML Prefilled Syringe
Intervention Type
Other
Intervention Name(s)
SoC
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of experimental treatment
Description
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.
Time Frame
up to 10 days
Title
Safety of experimental treatment
Description
Number of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE).
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Long-term efficacy
Description
Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment.
Time Frame
up to 10 days
Title
Time to achive a clinical response
Description
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 Frame
up to 40 days
Title
Time to achive an afebrile state
Description
period time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication.
Time Frame
up to 40 days
Title
time from symptom onset to treatment
Description
period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
Time Frame
up to day 1
Title
Responders
Description
Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
Time Frame
up to 40 days
Title
COVID-19 related relapse
Description
number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
Time Frame
up to 40 days
Title
Patients with Adverse Events
Description
number of patients with Any Adverse Events
Time Frame
up to 40 days
Title
Adverse Events
Description
Number of Adverse Events
Time Frame
up to 40 days
Title
Serious Adverse Events
Description
Number of Serious Adverse Events
Time Frame
up to 40 days
Title
Overall mortality
Description
number of patients who died
Time Frame
up to 40 days
Title
COVID-19 related mortality
Description
number of patients who died due to COVID-19
Time Frame
up to 40 days
Title
Time until death
Description
number of days from visit 1 until death
Time Frame
up to 40 days
Title
COVID-19-related complications
Description
number of patients who had any COVID-19 related complications
Time Frame
up to 40 days
Title
Patients requiring intensive care
Description
number of patients who require intensive care
Time Frame
up to 40 days
Title
patients requiring intensive care and invasive mechanical ventilation
Description
number of patients who require intensive care and invasive mechanical ventilation
Time Frame
up to 40 days
Title
patients requiring oxygen supplementation
Description
number of patients who require oxygen supplementation from hospital discharge up until visit 7
Time Frame
up to 40 days
Title
Patients with nonsocomial infection
Description
number (and percentage) of patients diagnosed with another nosocomial infection
Time Frame
up to 40 days
Title
Rehospitalizations
Description
number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge
Time Frame
up to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Catalonia
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Links:
URL
http://covid19.who.int.
Description
COVID19, WHO
URL
https://cima.aemps.es/cima/pdfs/es/ft/08461001/FT_08461001.pdf
Description
Icatibant (Firazyr®). Ficha técnica, Febrero 2019.

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

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