Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial.
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Menichetti Francesco, Popoli Patrizia, Puopolo Maria, Spila Alegiani Stefania, Tiseo Giusy, Bartoloni Alessandro, De Socio Giuseppe Vittorio, Luchi Sauro, Blanc Pierluigi, Puoti Massimo, Toschi Elena, Massari Marco, Palmisano Lucia, Marano Giuseppe, Chiamenti Margherita, Martinelli Laura, Franchi Silvia, Pallotto Carlo, Suardi Lorenzo Roberto, Luciani Pasqua Barbara, Merli Marco, Fabiani Plinio, Bertolucci Luca, Borchi Beatrice, Modica Sara, Moneta Sara, Marchetti Giulia, d'Arminio Monforte Antonella, Stoppini Laura, Ferracchiato Nadia, Piconi Stefania, Fabbri Claudio, Beccastrini Enrico, Saccardi Riccardo, Giacometti Andrea, Esperti Sara, Pierotti Piera, Bernini Laura, Bianco Claudia, Benedetti Sara, Lanzi Alessandra, Bonfanti Paolo, Massari Marco, Sani Spartaco, Saracino Annalisa, Castagna Antonella, Trabace Luigia, Lanza Maria, Focosi Daniele, Mazzoni Alessandro, Pistello Mauro, Falcone Marco, TSUNAMI Study group
Аннотация
OBJECTIVE: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia.
DESIGN, SETTING, AND PARTICIPANTS: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible.
INTERVENTIONS: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization.
RESULTS: Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04).
CONCLUSIONS AND RELEVANCE: In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04716556.