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http://hdl.handle.net/2445/185260
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DC Field | Value | Language |
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dc.contributor.author | Malchair, Pierre | - |
dc.contributor.author | Otero, Aurema | - |
dc.contributor.author | Giol, Jordi | - |
dc.contributor.author | Solanich, Xavier | - |
dc.contributor.author | Carnaval, Thiago | - |
dc.contributor.author | Fernández Nistal, Alonso | - |
dc.contributor.author | Sánchez Gabriel, Ana | - |
dc.contributor.author | Montoto, Carmen | - |
dc.contributor.author | Lleonart, Ramon | - |
dc.contributor.author | Videla, Sebas | - |
dc.contributor.author | Antolí, Arnau | - |
dc.contributor.author | Benjumeda, Marta | - |
dc.contributor.author | Bernal, Tania | - |
dc.contributor.author | Calatayud, Laura | - |
dc.contributor.author | Corbella, Xavier | - |
dc.contributor.author | Ferrer, Anna | - |
dc.contributor.author | Garcia, Vanesa | - |
dc.contributor.author | Gasa Galmés, Mercè | - |
dc.contributor.author | Gudiol, Carlota | - |
dc.contributor.author | Hereu, Pilar | - |
dc.contributor.author | Jacob, Javier | - |
dc.contributor.author | Jofre, Hector | - |
dc.contributor.author | Llopis Roca, Ferran | - |
dc.contributor.author | Matellan, Leire | - |
dc.contributor.author | Pallarés, Natàlia | - |
dc.contributor.author | Rigo Bonnin, Raúl | - |
dc.contributor.author | Rocamora, Gemma | - |
dc.contributor.author | Rodríguez, Freddy | - |
dc.contributor.author | Rombauts, Alexander | - |
dc.contributor.author | Ruibal, José Carlos | - |
dc.contributor.author | Sabater, Joan | - |
dc.contributor.author | Serrano, Carmen | - |
dc.contributor.author | Suárez Lledó, Ana | - |
dc.contributor.author | Tebé, Cristian | - |
dc.contributor.author | Villoria, Jesús | - |
dc.contributor.author | Zarauza, Alvaro | - |
dc.contributor.author | Icat-covid Team | - |
dc.date.accessioned | 2022-04-29T14:08:38Z | - |
dc.date.available | 2022-04-29T14:08:38Z | - |
dc.date.issued | 2022-04-12 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | http://hdl.handle.net/2445/185260 | - |
dc.description.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. | - |
dc.format.extent | 15 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Springer Science and Business Media | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1186/s13063-022-06219-7 | - |
dc.relation.ispartof | Trials, 2022 | - |
dc.relation.uri | https://doi.org/10.1186/s13063-022-06219-7 | - |
dc.rights | cc by (c) Malchair, Pierre et al, 2022 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | COVID-19 | - |
dc.subject.classification | Assistència hospitalària | - |
dc.subject.other | COVID-19 | - |
dc.subject.other | Hospital care | - |
dc.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) | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 730474 | - |
dc.date.updated | 2022-04-28T09:48:03Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 35413921 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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s13063-022-06219-7.pdf | 654.04 kB | Adobe PDF | View/Open |
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