TY - JOUR
T1 - A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia
AU - Avendaño-Solá, Cristina
AU - Ramos-Martínez, Antonio
AU - Muñez-Rubio, Elena
AU - Ruiz-Antorán, Belen
AU - Malo de Molina, Rosa
AU - Torres, Ferran
AU - Fernández-Cruz, Ana
AU - Calderon-Parra, Jorge
AU - Payares-Herrera, Concepcion
AU - Díaz de Santiago, Alberto
AU - Romera Martínez, Irene
AU - Pintos, Ilduara
AU - Lora-Tamayo, Jaime
AU - Mancheño-Losa, Mikel
AU - Paciello Coronel, Maria Liz
AU - Martinez-Gonzalez, A L
AU - Vidán-Estévez, Julia
AU - Nuñez-Orantos, Maria José
AU - Saez-Serrano, Maria Isabel
AU - Porras-Leal, Maria Lourdes
AU - Jarilla-Fernández, Maria Del Castillo
AU - Villares, Paula
AU - Perez de Oteyza, Jaime
AU - Ramos-Garrido, Ascensión
AU - Blanco, Lydia
AU - Madrigal-Sánchez, Maria Elena
AU - Rubio-Batllés, Martín
AU - Velasco-Iglesias, Ana
AU - Paño-Pardo, José Ramón
AU - Moreno-Chulilla, J A
AU - Muñiz-Diaz, Eduardo
AU - Casas-Flecha, Inmaculada
AU - Pérez-Olmeda, Mayte
AU - García-Pérez, Javier
AU - Alcami, Jose
AU - Bueno, José Luis
AU - Duarte, Rafael F
N1 - Publisher Copyright:
© 2021 American Society for Clinical Investigation. All rights reserved.
PY - 2021/9/2
Y1 - 2021/9/2
N2 - BACKGROUND: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is inconclusive.METHODS: We conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (non-invasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7(death) at 14 days, and primary analysis was performed in the intention-to-treat population.RESULTS: Between April 4, 2020 and February 5, 2021, 350 patients were randomly assigned to either CP (n=179) or SOC (n=171). At 14 days, proportion of patients on categories 5, 6 or 7 was 11.7% in CP group versus 16.4% in control group (p=0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in CP group versus 17.0% in control group (p=0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95%CI 0.19-1.14, log-rank p=0.087).CONCLUSION: CP showed a significant benefit in preventing progression to non-invasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATION: clinicaltrials.gov, NCT04345523FUNDING. Government of Spain, Instituto de Salud Carlos III.
AB - BACKGROUND: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is inconclusive.METHODS: We conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (non-invasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7(death) at 14 days, and primary analysis was performed in the intention-to-treat population.RESULTS: Between April 4, 2020 and February 5, 2021, 350 patients were randomly assigned to either CP (n=179) or SOC (n=171). At 14 days, proportion of patients on categories 5, 6 or 7 was 11.7% in CP group versus 16.4% in control group (p=0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in CP group versus 17.0% in control group (p=0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95%CI 0.19-1.14, log-rank p=0.087).CONCLUSION: CP showed a significant benefit in preventing progression to non-invasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATION: clinicaltrials.gov, NCT04345523FUNDING. Government of Spain, Instituto de Salud Carlos III.
KW - Aged
KW - COVID-19/mortality
KW - Combined Modality Therapy
KW - Disease Progression
KW - Female
KW - Hospitalization
KW - Humans
KW - Immunization, Passive/adverse effects
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Odds Ratio
KW - Pandemics
KW - SARS-CoV-2
KW - Spain/epidemiology
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85115922616&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/29dfc238-505c-34f0-a74f-9b4af41e40e1/
U2 - 10.1172/JCI152740
DO - 10.1172/JCI152740
M3 - Article
C2 - 34473652
SN - 0021-9738
VL - 131
JO - Journal of Clinical Investigation
JF - Journal of Clinical Investigation
IS - 20
M1 - e152740
ER -