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

Sebastian Videla73 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Pneumonia

Interventions

FirazyrDRUG

Icatibant 10 MG/ML Prefilled Syringe

SoCOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, Spain

Outcomes

Primary Outcomes

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.

Time frame: up to 10 days

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).

Time frame: up to 10 days

Secondary Outcomes

Long-term efficacy

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

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 frame: up to 40 days

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 frame: up to 40 days

time from symptom onset to treatment

period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).

Time frame: up to day 1

Responders

Data from ClinicalTrials.gov

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