2024-03-28T19:45:31Zhttp://repisalud.isciii.es/oai/requestoai:repisalud.isciii.es:20.500.12105/110072023-06-16T09:32:33Zcom_20.500.12105_15322com_20.500.12105_2051com_20.500.12105_2060com_20.500.12105_2052col_20.500.12105_16973col_20.500.12105_16964col_20.500.12105_16960col_20.500.12105_16938col_20.500.12105_2061
00925njm 22002777a 4500
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Avendaño-Solà, C
author
Ramos-Martínez, A
author
Muñez-Rubio, E
author
Ruiz-Antorán, Belén
author
Malo de Molina, R
author
Torres, F
author
Fernández-Cruz, A
author
Callejas-Díaz, A
author
Calderón, J
author
Payares-Herrera, C
author
Salcedo, I
author
Romera, I
author
Lora-Tamay, J
author
Mancheño-Losa, M
author
Paciello, ML
author
Villegas, C
author
Estrada, V
author
Saez-Serrano, I
author
Porras-Leal, ML
author
Jarilla-Fernández, MC
author
Paño-Pardo, JR
author
Moreno-Chulilla, JA
author
Arrieta-Aldea, I
author
Bosch, A
author
Belhassen-García, Moncef
author
López-Villar, O
author
Ramos-Garrido, A
author
Blanco, L
author
Madrigal-Sánchez, ME
author
Contreras, E
author
Muñiz-Díaz, E
author
Domingo-Morera, JM
author
Casas Flecha, Inmaculada
author
Bueno, JL
author
Perez-Olmeda, Mayte
author
García-Pérez, Javier
author
Alcamí, José
author
2020-09-01
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).
medRxiv preprint 2020 doi: https://doi.org/10.1101/2020.08.26.20182444
http://hdl.handle.net/20.500.12105/11007
10.1101/2020.08.26.20182444
medRxiv
Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial [preprint]