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Title: A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)
Author: Malchair, Pierre
Otero, Aurema
Giol, Jordi
Solanich, Xavier
Carnaval, Thiago
Fernández Nistal, Alonso
Sánchez Gabriel, Ana
Montoto, Carmen
Lleonart, Ramon
Videla, Sebas
Antolí, Arnau
Benjumeda, Marta
Bernal, Tania
Calatayud, Laura
Corbella, Xavier
Ferrer, Anna
Garcia, Vanesa
Gasa Galmés, Mercè
Gudiol, Carlota
Hereu, Pilar
Jacob, Javier
Jofre, Hector
Llopis Roca, Ferran
Matellan, Leire
Pallarés, Natàlia
Rigo Bonnin, Raúl
Rocamora, Gemma
Rodríguez, Freddy
Rombauts, Alexander
Ruibal, José Carlos
Sabater, Joan
Serrano, Carmen
Suárez Lledó, Ana
Tebé, Cristian
Villoria, Jesús
Zarauza, Alvaro
Icat-covid Team
Keywords: COVID-19
Assistència hospitalària
Hospital care
Issue Date: 12-Apr-2022
Publisher: Springer Science and Business Media
Abstract: Background: COVID-19 has quickly become a global pandemic with a substantial number of deaths and is a considerable burden for healthcare systems worldwide. Although most cases are paucisymptomatic and limited to the viral infection-related symptoms, some patients evolve to a second phase, with an impaired inflammatory response (cytokine storm) that may lead to acute respiratory distress syndrome and death. This is thought to be caused by increased bradykinin synthesis. Methods: ICAT-COVID is a multicenter, randomized, open-label, proof-of-concept phase II clinical trial assessing the clinical efficacy and safety of adding icatibant to the standard of care in patients hospitalized with COVID-19 without invasive mechanical ventilation. Patients hospitalized with a confirmed COVID-19 pneumonia diagnosis (RTPCR or antigen test <= 10 days prior to randomization, and radiographic evidence of pulmonary infiltrates), rated 4 or 5' on the WHO's clinical status scale, are eligible. Patients will be randomized on a 1:1 ratio to either standard of care-plus-icatibant (experimental group) or to standard of care alone (control group). The experimental group will receive 30 mg of icatibant subcutaneously 3 times a day for 3 days (for a total of 9 doses). The expected sample size is 120 patients (60 per group) from 2 sites in Spain. Primary outcomes are the efficacy and safety of Icatibant. The main efficacy outcome is the number of patients reaching grades 2 or 1 on the WHO scale within 10 days of starting treatment. Secondary outcomes include long-term efficacy: number of patients discharged who do not present COVID-19-related relapse or comorbidity up until 28 days after discharge, and mortality. Discussion: Icatibant, a bradykinin type 2 receptor antagonist with proven effectiveness and safety against hereditary angioedema attacks, may be beneficial for COVID-19 patients by inhibiting bradykinin's action on endothelial cells and by inhibiting the SARS-CoV-2 M protease. Our working hypothesis is that treatment with standard of care-plus-icatibant is effective and safe to treat patients infected with SARS-CoV-2 admitted to hospital for pneumonia without invasive mechanical ventilation.
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It is part of: Trials, 2022
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ISSN: 1745-6215
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Ciències Clíniques)

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