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Completed

NCT Number: NCT04978051

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

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.

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Key information

Conditions

COVID-19 Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Firazyr

Drug

Icatibant 10 MG/ML Prefilled Syringe

SOC

Other

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 outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. Responders

    Time frame: up to 40 days

    Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)

  6. 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

  7. Patients with Adverse Events

    Time frame: up to 40 days

    number of patients with Any Adverse Events

  8. Adverse Events

    Time frame: up to 40 days

    Number of Adverse Events

  9. Serious Adverse Events

    Time frame: up to 40 days

    Number of Serious Adverse Events

  10. Overall mortality

    Time frame: up to 40 days

    number of patients who died

  11. COVID-19 related mortality

    Time frame: up to 40 days

    number of patients who died due to COVID-19

  12. Time until death

    Time frame: up to 40 days

    number of days from visit 1 until death

  13. COVID-19-related complications

    Time frame: up to 40 days

    number of patients who had any COVID-19 related complications

  14. Patients requiring intensive care

    Time frame: up to 40 days

    number of patients who require intensive care

  15. 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

  16. patients requiring oxygen supplementation

    Time frame: up to 40 days

    number of patients who require oxygen supplementation from hospital discharge up until visit 7

  17. Patients with nonsocomial infection

    Time frame: up to 40 days

    number (and percentage) of patients diagnosed with another nosocomial infection

  18. Rehospitalizations

    Time frame: up to 40 days

    number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge

Sponsors and collaborators

Lead sponsor

Sebastian Videla

Other

Registry information

Official study 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

Acronym: ICAT·COVID

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 27, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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