Por favor, use este identificador para citar o enlazar este Item:http://hdl.handle.net/20.500.12105/11007
Título
Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial
Autor(es)
Avendaño-Solà, C | Ramos-Martínez, A | Muñez-Rubio, E | Ruiz-Antorán, Belén | Malo de Molina, R | Torres, F | Fernández-Cruz, A | Callejas-Díaz, A | Calderón, J | Payares-Herrera, C | Salcedo, I | Romera, I | Lora-Tamay, J | Mancheño-Losa, M | Paciello, ML | Villegas, C | Estrada, V | Saez-Serrano, I | Porras-Leal, ML | Jarilla-Fernández, MC | Paño-Pardo, JR | Moreno-Chulilla, JA | Arrieta-Aldea, I | Bosch, A | Belhassen-García, Moncef | López-Villar, O | Ramos-Garrido, A | Blanco, L | Madrigal-Sánchez, ME | Contreras, E | Muñiz-Díaz, E | Domingo-Morera, JM | Casas Flecha, Inmaculada ISCIII | Bueno, JL | Perez-Olmeda, Mayte ISCIII | García-Pérez, Javier ISCIII | Alcamí, José ISCIII
Fecha de publicación
2020-09-01
Cita
medRxiv 2020.08.26.20182444.
Idioma
Inglés
Tipo de documento
preprint
Resumen
Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).
Versión en línea
DOI
Aparece en las colecciones
- Investigación > IIS > IIS Aragón - Instituto de Investigación Sanitaria Aragón (Aragón)
- Investigación > ISCIII > Centro Nacional de Microbiología (CNM)
- Investigación > IIS > i+12 - Instituto de Investigación Hospital 12 de Octubre (Madrid)
- Investigación > IIS > IBSAL - Instituto de Investigación Biómedica de Salamanca (Castilla y León)
- Investigación > IIS > IDIPHIM - Instituto de Investigación Sanitaria Puerta de Hierro (Madrid)