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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04978051
Recruitment Status : Completed
First Posted : July 27, 2021
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Sebastian Videla, Hospital Universitari de Bellvitge

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

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Study Type : Interventional  (Clinical Trial)
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 : April 12, 2021
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : March 17, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978051


Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Catalonia, Spain, 08907
Sponsors and Collaborators
Sebastian Videla
Additional Information:
Publications:
Cicardi M, Banerji A, Bracho F, Malbrán A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anné S, Björkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hébert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernández Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393. Erratum in: N Engl J Med. 2010 Oct 7;363(15):1486.
Van De Veerdonk FL, Netea MG, van Deuren M, van der Meer JWM, de Mast Q, Brüggemann RJ, van der Hoeven H. Kinins and cytokines in COVID-19: a comprehensive pathophysiological approach. 10.20944/preprints202004.0023.v1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 27, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Sebastian Videla, Hospital Universitari de Bellvitge:
icatibant
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Bradykinin B2 Receptor Antagonists
Bradykinin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors