Blockade of Interleukin Seventeen (IL-17A) with Secukinumab in Hospitalized COVID-19 patients – the BISHOP study
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Le résumé fourni par la source
ABSTRACT Background Patients with severe COVID-19 seem to have a compromised antiviral response and hyperinflammation. Neutrophils are critical players in COVID-19 pathogenesis. IL-17A plays a major role in protection against extracellular pathogens and neutrophil attraction and activation. We hypothesized that secukinumab, an anti-IL17A monoclonal antibody, could mitigate the deleterious hyperinflammation in COVID-19. Methods BISHOP was an open-label, single-center, phase-II controlled trial. Fifty adults hospitalized Covid-19 patients, confirmed by a positive SARS-CoV-2 RT-PCR, were randomized 1:1 to receive 300mg of secukinumab subcutaneously at day-0 (group A) plus standard of care (SoC: antiviral drugs, antimicrobials, corticosteroids, and/or anticoagulants) or SoC alone (group B). A second dose of 300mg of secukinumab could be administered on day-7, according to staff judgment. The primary endpoint was ventilator-free days at day-28 (VFD-28). Secondary efficacy and safety outcomes were also explored. Findings An intention-to-treat analysis showed no difference in VFD-28: 23.7 (95%CI 19.6-27.8) in group A vs. 23.8 (19.9-27.6) in group B, p=0.62; There was also no difference in hospitalization time, intensive care unit demand, the incidence of circulatory shock, acute kidney injury, fungal or bacterial co-infections, and severe adverse events. Pulmonary thromboembolism was less frequent in group A (4.2% vs. 26.2% p=0.04). There was one death in each group. Viral clearance, defined by the viral load fold change (2-ΔΔCT) in upper airways, between day-0 and day-7, was also similar: 0.17 (0.05-0.56) in group A vs. 0.24 (0.10-0.57) in group B. Interpretation The efficacy of secukinumab in the treatment of Covid19 was not demonstrated. No difference between groups in adverse events and no unexpected events were observed. Funding Novartis Brazil supported this research providing expert input in the development of the project, drug supply, data management, and monitoring.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Blockade of Interleukin Seventeen (IL-17A) with Secukinumab in Hospitalized COVID-19 patients – the BISHOP study
- Date Crossref
- 23/07/2021
- Éditeur
- openRxiv
- Type
- posted-content
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Hospital das Clínicas da Universidade Federal de Minas Gerais pays non établi dans la noticeÉtablissement de santé
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Hospital Risoleta Tolentino Neves pays non établi dans la noticeÉtablissement de santé
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D’Or Institute for Research and Education pays non établi dans la noticeOrganisation à but non lucratif
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Universidade Federal de Lavras Dept. of Statistics pays non établi dans la noticeUniversité ou école supérieure
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Hospital das Clínicas - Universidade Federal de Minas Gerais (UFMG) Rheumatology Unit pays non établi dans la noticeUniversité ou école supérieure
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Dept. of Genetics pays non établi dans la noticeInstitution
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Instituto D’Or de Pesquisa e Ensino (IDOR) pays non établi dans la noticeStructure de recherche
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Novartis Brazil pays non établi dans la noticeInstitution
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Dept. of Biochemistry and Immunology UFMG pays non établi dans la noticeInstitution
Hospital das Clínicas da Universidade Federal de Minas Gerais, Hospital Risoleta Tolentino Neves et D’Or Institute for Research and Education, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.