A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia
Por:
Avendano-Sola, C, Ramos-Martinez, A, Munez-Rubio, E, Ruiz-Antoran, B, de Molina, RM, Torres, F, Fernandez-Cruz, A, Calderon-Parra, J, Payares-Herrera, C, de Santiago, AD, Romera-Martinez, I, Pintos, I, Lora-Tamayo, J, Mancheno-Losa, M, Paciello, ML, Martinez-Gonzalez, AL, Vidan-Estevez, J, Nunez-Orantos, MJ, Saez-Serrano, MI, Porras-Leal, ML, Jarilla-Fernandez, MC, Villares, P, de Oteyza, JP, Ramos-Garrido, A, Blanco, L, Madrigal-Sanchez, ME, Rubio-Batlles, M, Velasco-Iglesias, A, Pano-Pardo, JR, Moreno-Chulilla, JA, Muniz-Diaz, E, Casas-Flecha, I, Perez-Olmeda, M, Garcia-Perez, J, Alcami, J, Bueno, JL, Duarte, RF, Bösch A., Villegas da Ros, Carolina
Publicada:
15 oct 2021
Resumen:
BACKGROUND. Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. 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 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. 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 in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the 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 noninvasive 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.
Filiaciones:
Avendano-Sola, C:
Hosp Univ Puerta Hierro Majadahonda, Inst Invest Sanitaria Hosp Puerta Hierro Segovia, Clin Pharmacol Dept, SCReN Clin Trials Platform, Madrid, Spain
Ramos-Martinez, A:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Munez-Rubio, E:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Ruiz-Antoran, B:
Hosp Univ Puerta Hierro Majadahonda, Inst Invest Sanitaria Hosp Puerta Hierro Segovia, Clin Pharmacol Dept, SCReN Clin Trials Platform, Madrid, Spain
de Molina, RM:
Hosp Univ Puerta Hierro Majadahonda, Resp Med Serv, Madrid, Spain
Torres, F:
Hosp Clin Barcelona, Clin Pharmacol Dept, Barcelona, Spain
Univ Autonoma Barcelona, Fac Med, Biostat Unit, Barcelona, Spain
Fernandez-Cruz, A:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Calderon-Parra, J:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Payares-Herrera, C:
Hosp Univ Puerta Hierro Majadahonda, Inst Invest Sanitaria Hosp Puerta Hierro Segovia, Clin Pharmacol Dept, SCReN Clin Trials Platform, Madrid, Spain
de Santiago, AD:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Romera-Martinez, I:
Hosp Univ Puerta Hierro Majadahonda, Dept Hematol, Calle Joaquin Rodrigo 2, Madrid, Spain
Pintos, I:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Lora-Tamayo, J:
Hosp Univ 12 Octubre, Inst Invest I 12, Dept Internal Med, Madrid, Spain
Mancheno-Losa, M:
Hosp Univ 12 Octubre, Inst Invest I 12, Dept Internal Med, Madrid, Spain
Paciello, ML:
Hosp Univ 12 Octubre, Dept Hematol, Madrid, Spain
Martinez-Gonzalez, AL:
Complejo Asistencial Univ Leon, Dept Internal Med, Leon, Spain
Vidan-Estevez, J:
Complejo Asistencial Univ Leon, Dept Hematol, Leon, Spain
Nunez-Orantos, MJ:
Hosp Univ Clin San Carlos, Dept Internal Med, Infect Dis Unit, Madrid, Spain
Saez-Serrano, MI:
Hosp Univ Clin San Carlos, Hematol Serv, Madrid, Spain
Porras-Leal, ML:
Hosp Gen Univ Ciudad Real, Dept Internal Med, Infect Dis Unit, Ciudad Real, Spain
Jarilla-Fernandez, MC:
Hosp Gen Univ Ciudad Real, Hematol & Hemotherapy Serv, Ciudad Real, Spain
Villares, P:
Hosp Univ HM Sanchinarro, Dept Internal Med, Madrid, Spain
de Oteyza, JP:
Univ CEU San Pablo Madrid, Hosp Univ HM Sanchinarro, Dept Hematol, Madrid, Spain
Ramos-Garrido, A:
Minist Def, Blood Transfus Mil Ctr, Madrid, Spain
Blanco, L:
Ctr Hemoterapia & Hemodonac Castilla & Leon, Valladolid, Spain
Madrigal-Sanchez, ME:
Hosp Gen Univ Ciudad Real, Ctr Transfus Ciudad Real, Ciudad Real, Spain
Rubio-Batlles, M:
Ctr Transfus Albacete & Cuenca, Albacete, Spain
Velasco-Iglesias, A:
IIS Hosp Puerta Hierro Segovia Arana, Spanish Clin Res Network ISCIII, Madrid, Spain
Pano-Pardo, JR:
Hosp Clin Univ Zaragoza IIS Aragon, Div Infect Dis, Zaragoza, Spain
Moreno-Chulilla, JA:
Hosp Clin Univ Zaragoza IIS Aragon, Div Hematol, Zaragoza, Spain
Muniz-Diaz, E:
Banc Sang & Teixits, Inmunohematol Div, Barcelona, Spain
Casas-Flecha, I:
Inst Salud Carlos III, Ctr Nacl Microbiol, Resp Virus & Influenza Unit, Madrid, Spain
Perez-Olmeda, M:
Inst Salud Carlos III, Ctr Nacl Microbiol, Lab Serol, Madrid, Spain
Garcia-Perez, J:
Inst Salud Carlos III, AIDS Immunopathogenesis Unit, Madrid, Spain
Alcami, J:
Inst Salud Carlos III, AIDS Immunopathogenesis Unit, Madrid, Spain
Bueno, JL:
Hosp Univ Puerta Hierro Majadahonda, Dept Hematol, Calle Joaquin Rodrigo 2, Madrid, Spain
Duarte, RF:
Hosp Univ Puerta Hierro Majadahonda, Dept Hematol, Calle Joaquin Rodrigo 2, Madrid, Spain
Bösch A.:
Banc Sang & Teixits, Inmunohematol Div, Barcelona, Spain
Villegas da Ros, Carolina:
Hospital General Universitario de Valencia
Bronze, Green Published
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