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A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia.
Avendaño-Solá, Cristina; Ramos-Martínez, Antonio; Muñez-Rubio, Elena; Ruiz-Antorán, Belen; Malo de Molina, Rosa; Torres, Ferran; Fernández-Cruz, Ana; Calderón-Parra, Jorge; Payares-Herrera, Concepcion; Díaz de Santiago, Alberto; Romera-Martínez, Irene; Pintos, Ilduara; Lora-Tamayo, Jaime; Mancheño-Losa, Mikel; Paciello, Maria L; Martínez-González, A L; Vidán-Estévez, Julia; Nuñez-Orantos, Maria J; Saez-Serrano, Maria Isabel; Porras-Leal, Maria L; Jarilla-Fernández, Maria C; Villares, Paula; de Oteyza, Jaime Pérez; Ramos-Garrido, Ascension; Blanco, Lydia; Madrigal-Sánchez, Maria E; Rubio-Batllés, Martin; Velasco-Iglesias, Ana; Paño-Pardo, José R; Moreno-Chulilla, J A; Muñiz-Díaz, Eduardo; Casas-Flecha, Inmaculada; Pérez-Olmeda, Mayte; García-Pérez, Javier; Alcamí, Jose; Bueno, Jose L; Duarte, Rafael F.
  • Avendaño-Solá C; Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
  • Ramos-Martínez A; Infectious Diseases Unit, Department of Internal Medicine and.
  • Muñez-Rubio E; Infectious Diseases Unit, Department of Internal Medicine and.
  • Ruiz-Antorán B; Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
  • Malo de Molina R; Respiratory Medicine Service, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
  • Torres F; Clinical Pharmacology Department, Hospital Clinic Barcelona, Barcelona, Spain.
  • Fernández-Cruz A; Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
  • Calderón-Parra J; Infectious Diseases Unit, Department of Internal Medicine and.
  • Payares-Herrera C; Infectious Diseases Unit, Department of Internal Medicine and.
  • Díaz de Santiago A; Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, SCReN Clinical Trials Platform, Madrid, Spain.
  • Romera-Martínez I; Infectious Diseases Unit, Department of Internal Medicine and.
  • Pintos I; Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
  • Lora-Tamayo J; Infectious Diseases Unit, Department of Internal Medicine and.
  • Mancheño-Losa M; Department of Internal Medicine, Instituto de Investigación "i+12" and.
  • Paciello ML; Department of Internal Medicine, Instituto de Investigación "i+12" and.
  • Martínez-González AL; Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Vidán-Estévez J; Department of Internal Medicine, and.
  • Nuñez-Orantos MJ; Department of Hematology, Complejo Asistencial Universitario de León, León, Spain.
  • Saez-Serrano MI; Infectious Diseases Unit, Department of Internal Medicine and.
  • Porras-Leal ML; Hematology Service, Hospital Universitario Clinico San Carlos, Madrid, Spain.
  • Jarilla-Fernández MC; Infectious Diseases Unit, Department of Internal Medicine, and.
  • Villares P; Hematology and Hemotherapy Service, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
  • de Oteyza JP; Department of Internal Medicine, Hospital Universitario HM Sanchinarro, Madrid, Spain.
  • Ramos-Garrido A; Department of Hematology, Hospital Universitario HM Sanchinarro, Universidad CEU San Pablo Madrid, Spain.
  • Blanco L; Blood Transfusion Military Center, Ministry of Defense, Spain.
  • Madrigal-Sánchez ME; Centro de Hemoterapia y Hemodonación de Castilla y León, Valladolid, Spain.
  • Rubio-Batllés M; Centro de Transfusión de Ciudad Real, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
  • Velasco-Iglesias A; Centro de Transfusión de Albacete y Cuenca, Albacete, Spain.
  • Paño-Pardo JR; Spanish Clinical Research Network (ISCIII), IIS -Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.
  • Moreno-Chulilla JA; Division of Infectious Diseases and.
  • Muñiz-Díaz E; Division of Hematology, Hospital Clínico Universitario Zaragoza-IIS Aragón, Zaragoza, Spain.
  • Casas-Flecha I; Inmunohematology Division, Banc de Sang i Teixits, Barcelona, Spain.
  • Pérez-Olmeda M; Respiratory Virus and Influenza Unit and.
  • García-Pérez J; Laboratorio de Serología, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Madrid, Spain.
  • Alcamí J; AIDS Immunopathogenesis Unit, Instituto de Salud Carlos III, Madrid, Spain.
  • Bueno JL; AIDS Immunopathogenesis Unit, Instituto de Salud Carlos III, Madrid, Spain.
  • Duarte RF; Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
J Clin Invest ; 131(20)2021 10 15.
Article in English | MEDLINE | ID: covidwho-1626086
ABSTRACT
BACKGROUNDPassive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive.METHODSWe 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 11 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.RESULTSBetween 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).CONCLUSIONCP 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.TRIAL REGISTRATIONClinicaltrials.gov, NCT04345523.FUNDINGGovernment of Spain, Instituto de Salud Carlos III.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Year: 2021 Document Type: Article Affiliation country: Jci152740

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Year: 2021 Document Type: Article Affiliation country: Jci152740