Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Manzini Paola Maria, Ciccone Giovannino, De Rosa Francesco Giuseppe, Cavallo Rossana, Ghisetti Valeria, D'Antico Sergio, Galassi Claudia, Saccona Fabio, Castiglione Anna, Birocco Nadia, Francisci Tiziana, Hu Huijing, Pecoraro Clara, Danielle Franca, Labanca Luciana, Bordiga Anna Maria, Lorenzi Marco, Camisasca Giovanni, Giachino Osvaldo, Pagliarino Mauro, Ottone Piero, Scuvera Ilvana Tiziana Donatella, Guaschino Roberto, Freilone Roberto, Berti Pierluigi, Pittaluga Fabrizia, Avolio Maria, Costa Cristina, Raso Samuele, Nucci Aurora, Milan Massimo, Baffa Alessandra, Russo Alessandra, Tornello Antonella, Maddalena Laura, Delios Grazia, Marletto Fabio Paolo, De Micheli Anna Grazia, Mattei Alessio, Baldassano Stefano, Canta Francesca, Russo Maria Luisa, Bergamo Daniele, Vitale Francesco, Liccardi Marco Maria, Chinaglia Alessandra, Calcagno Andrea, Converso Marcella, Aldieri Chiara, Libanore Valentina, Blangetti Ilaria, Benedetti Valentina, Mitola Barbara, Scozzari Gitana, PLACO COVID Study Group
Аннотация
METHODS: To determine whether convalescent or standard plasma would improve outcomes for adults in early phase of Covid19 respiratory impairment we designed this randomized, three-arms, clinical trial (PLACO COVID) blinded on interventional arms that was conducted from June 2020 to August 2021. It was a multicentric trial at 19 Italian hospitals. We enrolled 180 hospitalized adult patients with COVID-19 pneumonia within 5 days from the onset of respiratory distress. Patients were randomly assigned in a 1:1:1 ratio to standard of care (n = 60) or standard of care + three units of standard plasma (n = 60) or standard of care + three units of high-titre convalescent plasma (n = 60) administered on days 1, 3, 5 after randomization. Primary outcome was 30-days mortality. Secondary outcomes were: incidence of mechanical ventilation or death at day 30, 6-month mortality, proportion of days with mechanical ventilation on total length of hospital stay, IgG anti-SARS-CoV-2 seroconversion, viral clearance from plasma and respiratory tract samples, and variations in Sequential Organ Failure Assessment score. The trial was analysed according to the intention-to-treat principle.
RESULTS: 180 patients (133/180 [73.9%] males, mean age 66.6 years [IQR 57-73]) were enrolled a median of 8 days from onset of symptoms. At enrollment, 88.9% of patients showed moderate/severe respiratory failure. 30-days mortality was 20% in Control arm, 23% in Convalescent (risk ratio [RR] 1.13; 95% confidence interval [CI], 0.61-2.13, P = 0.694) and 25% in Standard plasma (RR 1.23; 95%CI, 0.63-2.37, P = 0.544). Time to viral clearance from respiratory tract was 21 days for Convalescent, 28 for Standard plasma and 23 in Control arm but differences were not statistically significant. No differences for other secondary endpoints were seen in the three arms. Serious adverse events were reported in 1.7%, 3.3% and 5% of patients in Control, Standard and Convalescent plasma arms respectively.
CONCLUSIONS: Neither high-titer Convalescent nor Standard plasma improve outcomes of COVID-19 patients with acute respiratory failure. Trial Registration Clinicaltrials.gov Identifier: NCT04428021. First posted: 11/06/2020.