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.

Autor: Manzini PM; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy. pmanzini@cittadellasalute.to.it., Ciccone G; Unit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy., De Rosa FG; Department of Medical Science, University of Turin Faculty of Medicine and Surgery, Turin, Italy., Cavallo R; Laboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy., Ghisetti V; Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, Turin, Italy., D'Antico S; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Galassi C; Unit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy., Saccona F; Unit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy., Castiglione A; Unit of Clinical Epidemiology, University Hospital City of Science and Health Turin, CPO Piemonte, Turin, Italy., Birocco N; Oncology Department, University Hospital City of Science and Health Turin, Turin, Italy., Francisci T; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Hu H; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Pecoraro C; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Danielle F; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Labanca L; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Bordiga AM; Transfusion Medicine and Blood Establishment, University Hospital City of Science and Health Turin, Corso Bramante 88, 10126, Turin, Italy., Lorenzi M; Immunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy., Camisasca G; Transfusion Medicine and Blood Establishment, Holy Trinity Hospital Borgomanero, Borgomanero, Italy., Giachino O; Transfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy., Pagliarino M; Maternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy., Ottone P; Transfusion Medicine, San Luigi Gonzaga University Hospital, Orbassano, Italy., Scuvera ITD; Immunohematology and Transfusion Medicine, Cardinal Massaia Hospital of Asti, Asti, Italy., Guaschino R; Transfusion Medicine, Saints Anthony and Biagio and Cesare Arrigo Alessandria National Hospital, Alessandria, Italy., Freilone R; Transfusion Medicine, Ivrea Hospital, Ivrea, Italy., Berti P; Immunohematology and Transfusion Medicine, Umberto Parini Hospital, Aosta, Italy., Pittaluga F; Laboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy., Avolio M; Laboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy., Costa C; Laboratory of Microbiology and Virology, University Hospital City of Science and Health Turin, Turin, Italy., Raso S; Maternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy., Nucci A; Maternal, Pediatric and Trauma Transfusion Medicine, University Hospital City of Science and Health Turin, Turin, Italy., Milan M; Transfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy., Baffa A; Transfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy., Russo A; Transfusion Medicine, San Giovanni Bosco Hospital, Turin, Italy., Tornello A; Immunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy.; Immunohematology and Transfusion Medicine, ASL CN1 Mondovì, Mondovì, Italy., Maddalena L; Immunohematology and Transfusion Medicine, S Croce and Carle Cuneo Hospital District, Cuneo, Italy., Delios G; Transfusion Medicine, Ivrea Hospital, Ivrea, Italy., Marletto FP; Immunohematology and Transfusion Medicine, Umberto Parini Hospital, Aosta, Italy., De Micheli AG; Medical Emergency Division, University Hospital City of Science and Health Turin, Turin, Italy., Mattei A; Pulmunology Unit, University Hospital City of Science and Health Turin, Turin, Italy., Baldassano S; Department of Clinical and Biological Science, Faculty of Medicine and Surgery, University of Turin, Turin, Italy., Canta F; Infectious Diseases Unit, University Hospital City of Science and Health Turin, Turin, Italy., Russo ML; Internal Medicine Unit, Santa Croce Hospital of Moncalieri, Moncalieri, Italy., Bergamo D; Internal Medicine Unit, Santa Croce Hospital of Moncalieri, Moncalieri, Italy., Vitale F; Internal Medicine Unit, Ordine Mauriziano Di Torino Hospital, Turin, Italy., Liccardi MM; Intensive Care Unit, Hospital of Chivasso, Chivasso, Italy., Chinaglia A; Cardiology Unit, Martini Hospital, Turin, Italy., Calcagno A; Infectious Diseases Unit, Department of Medical Sciences, University of Turin Faculty of Medicine and Surgery, Turin, Italy., Converso M; Intensive Care Unit, San Giovanni Bosco Hospital, Turin, Italy., Aldieri C; Infectious Diseases, S Croce and Carle Cuneo Hospital District, Cuneo, Italy., Libanore V; Infectious Diseases Unit, Cardinal Massaia Hospital of Asti, Asti, Italy., Blangetti I; Intensive Care Unit, Mondovì Hospital, Mondovì, Italy., Benedetti V; Internal Medicine Unit, Mondovì Hospital, Mondovì, Italy., Mitola B; Hospital Medical Direction, Ordine Mauriziano di Torino Hospital, Turin, Italy., Scozzari G; Molinette Hospital Medical Direction, University Hospital City of Science and Health Turin, Turin, Italy.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2022 Nov 22; Vol. 22 (1), pp. 879. Date of Electronic Publication: 2022 Nov 22.
DOI: 10.1186/s12879-022-07716-5
Abstrakt: Background: The efficacy of early treatment with convalescent plasma in patients with COVID-19 is debated. Nothing is known about the potential effect of other plasma components other than anti-SARS-CoV-2 antibodies.
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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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