دورية أكاديمية
Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO) : a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial
| العنوان: | Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO) : a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial |
|---|---|
| المؤلفون: | Vlaar, Alexander P.J., Witzenrath, Martin, van Paassen, Pieter, Heunks, Leo M.A., Mourvillier, Bruno, de Bruin, Sanne, Lim, Endry H.T., Brouwer, Matthijs C., Tuinman, Pieter R., Saraiva, Jose F.K., Marx, Gernot, Lobo, Suzana M., Boldo, Rodrigo, Simon-Campos, Jesus A., Cornet, Alexander D., Grebenyuk, Anastasia, Engelbrecht, Johannes M., Mukansi, Murimisi, Jorens, Philippe, Zerbib, Robert, Rueckinger, Simon, Pilz, Korinna, Guo, Renfeng, van de Beek, Diederik, Riedemann, Niels C. |
| المساهمون: | PANAMO Study Group |
| المصدر: | 2213-2600 ; The lancet respiratory medicine |
| سنة النشر: | 2022 |
| المجموعة: | IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: | Human medicine |
| الوصف: | Background Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves survival outcomes in this patient population. Methods This randomised, double-blind, placebo-controlled, multicentre phase 3 trial was performed at 46 hospitals in the Netherlands, Germany, France, Belgium, Russia, Brazil, Peru, Mexico, and South Africa. Participants aged 18 years or older who were receiving invasive mechanical ventilation, but not more than 48 h after intubation at time of first infusion, had a PaO 2/FiO 2 ratio of 60-200 mm Hg, and a confirmed SARS-CoV-2 infection with any variant in the past 14 days were eligible for this study. Eligible patients were randomly assigned (1:1) to receive standard of care and vilobelimab at a dose of 800 mg intravenously for a maximum of six doses (days 1, 2, 4, 8, 15, and 22) or standard of care and a matching placebo using permuted block randomisation. Treatment was not continued after hospital discharge. Participants, caregivers, and assessors were masked to group assignment. The primary outcome was defined as all-cause mortality at 28 days in the full analysis set (defined as all randomly assigned participants regardless of whether a patient started treatment, excluding patients randomly assigned in error) and measured using KaplanMeier analysis. Safety analyses included all patients who had received at least one infusion of either vilobelimab or placebo. This study is registered with ClinicalTrials.gov, NCT04333420. Findings From Oct 1, 2020, to Oct 4, 2021, we included 368 patients in the ITT analysis ( full analysis set; 177 in the vilobelimab group and 191 in the placebo group). One patient in the vilobelimab group was excluded from the primary analysis due to random assignment in error without treatment. At least one dose of study treatment was given to 364 (99%) patients (safety analysis set). 54 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/isi/000944512500029 |
| الإتاحة: | https://doi.org/10.1016/S2213-2600Test(22)00297-1 https://hdl.handle.net/10067/1953700151162165141Test https://repository.uantwerpen.be/docstore/d:irua:16978Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.E4BA8860 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |