1. 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
- Author
-
Menichetti, F., Popoli, P., Puopolo, M., Alegiani, S. S., Tiseo, G., Bartoloni, A., De Socio, G., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Pasqua, B. L., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., d'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Locatelli, F., Ippolito, G., Magrini, N., Bernardini, R., Brusaferro, S., De Angelis, V., Perotti, C., Remuzzi, G., De Silvestro, G., Costantini, M., Bocchino, M., De Donno, G., Francisci, D., Menichetti, F., Popoli, P., Puopolo, M., Spila Alegiani, S., Tiseo, G., Bartoloni, A., De Socio, G. V., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Luciani Pasqua, B., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., D'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Menichetti, F, Popoli, P, Puopolo, M, Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, G, Luchi, S, Blanc, P, Puoti, M, Toschi, E, Massari, M, Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, L, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C, Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, and Falcone, M
- Subjects
Male ,medicine.medical_specialty ,Randomization ,Settore MED/17 - Malattie Infettive ,Population ,Aged ,COVID-19 ,Disease Progression ,Female ,Humans ,Italy ,Middle Aged ,Prospective Studies ,SARS-CoV-2 ,Severity of Illness Index ,Standard of Care ,Hospital Mortality ,Hospitalization ,Immunization, Passive ,Plasma ,Respiratory Insufficiency ,Passive ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,Clinical endpoint ,medicine ,education ,Adverse effect ,education.field_of_study ,business.industry ,General Medicine ,Odds ratio ,medicine.disease ,Pneumonia ,Respiratory failure ,Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA ,Immunization ,business - Abstract
Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. 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
- Published
- 2021