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
| Autor: | 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. |
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| Přispěvatelé: | 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, Falcone, M |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
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 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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