Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study.

Autor: Rojas M; School of Medicine and Health Sciences, Doctoral Program in Biological and Biomedical Sciences, Universidad del Rosario, Bogota, Colombia.; Division of Rheumatology, Allergy and Clinical Immunology, University of California, Davis, Davis, CA, USA., Rodríguez Y; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia., Hernández JC; Clínica del Occidente, Bogota, Colombia., Díaz-Coronado JC; Internal Medicine Department, Universidad CES, Medellin, Colombia., Vergara JAD; Hospital Universitario Mayor -Méderi, Universidad del Rosario, Bogota, Colombia., Vélez VP; Clinica CES, Medellin, Colombia., Mancilla JP; Clinica CES, Medellin, Colombia., Araujo I; Internal Medicine Department, Universidad CES, Medellin, Colombia., Yepes JT; Hospital Universitario Mayor -Méderi, Universidad del Rosario, Bogota, Colombia., Ricaurte OB; Hospital Universitario Mayor -Méderi, Universidad del Rosario, Bogota, Colombia., Pardo-Oviedo JM; Hospital Universitario Mayor -Méderi, Universidad del Rosario, Bogota, Colombia., Monsalve DM; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia., Acosta-Ampudia Y; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia., Ramírez-Santana C; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia., García PG; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Landinez LA; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Correales LD; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Grass JS; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Pérez CR; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., López GS; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Mateus N; Clínica del Occidente, Bogota, Colombia., Mancera L; Clínica del Occidente, Bogota, Colombia., Devia RR; Clínica del Occidente, Bogota, Colombia., Orjuela JE; Clínica del Occidente, Bogota, Colombia., Parra-Moreno CR; Clínica del Occidente, Bogota, Colombia., Buitrago AA; Clínica del Occidente, Bogota, Colombia., Ordoñez IE; Clínica del Occidente, Bogota, Colombia., Osorio CF; Clinica CES, Medellin, Colombia., Ballesteros N; Centro de Investigaciones en Microbiología Y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia., Patiño LH; Centro de Investigaciones en Microbiología Y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia., Castañeda S; Centro de Investigaciones en Microbiología Y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia., Muñoz M; Centro de Investigaciones en Microbiología Y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia., Ramírez JD; Centro de Investigaciones en Microbiología Y Biotecnología-UR (CIMBIUR), Facultad de Ciencias Naturales, Universidad del Rosario, Bogotá, Colombia.; Molecular Microbiology Laboratory, Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA., Bastard P; St Giles Laboratory of Human Genetics of Infectious Diseases, Rockefeller Branch, The Rockefeller University, New York, NY, USA.; Laboratory of Human Genetics of Infectious Diseases, Necker Branch, INSERM, Necker Hospital for Sick Children, Paris, France.; University of Paris, Imagine Institute, Paris, France.; Department of Pediatrics, Necker Hospital for Sick Children, Paris, France., Gervais A; University of Paris, Imagine Institute, Paris, France.; Laboratory of Human Genetics of Infectious Diseases, Necker Branch, INSERM U1163, Necker Hospital for Sick Children, Paris, France., Bizien L; University of Paris, Imagine Institute, Paris, France.; Laboratory of Human Genetics of Infectious Diseases, Necker Branch, INSERM U1163, Necker Hospital for Sick Children, Paris, France., Casanova JL; Laboratory of Human Genetics of Infectious Diseases, Necker Branch, INSERM, Necker Hospital for Sick Children, Paris, France.; University of Paris, Imagine Institute, Paris, France.; Department of Pediatrics, Necker Hospital for Sick Children, Paris, France.; University of Paris, Imagine Institute, Paris, France.; Department of Pediatrics, Necker Hospital for Sick Children, Paris, France.; Howard Hughes Medical Institute, Paris, France., Camacho B; Instituto Distrital de Ciencia Biotecnología E Investigación en Salud, IDCBIS, Bogota, Colombia., Gallo JE; Genoma CES, Universidad CES, Medellin, Colombia., Gómez O; Genoma CES, Universidad CES, Medellin, Colombia., Rojas-Villarraga A; Fundación Universitaria de Ciencias de la Salud (FUCS), Bogota, Colombia., Pérez CE; Infectious Diseases, Clínica de Marly, 110231, Bogotá, Colombia., Manrique R; Epidemiology and Biostatistics Research Group, Universidad CES, Medellin, Colombia., Mantilla RD; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia., Anaya JM; Center for Autoimmune Diseases Research (CREA), School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia. anayajm@gmail.com.; LifeFactors, Rionegro, Colombia. anayajm@gmail.com.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2022 Jun 27; Vol. 22 (1), pp. 575. Date of Electronic Publication: 2022 Jun 27.
DOI: 10.1186/s12879-022-07560-7
Abstrakt: Background: Convalescent plasma (CP) has been widely used to treat COVID-19 and is under study. However, the variability in the current clinical trials has averted its wide use in the current pandemic. We aimed to evaluate the safety and efficacy of CP in severe coronavirus disease 2019 (COVID-19) in the early stages of the disease.
Methods: A randomized controlled clinical study was conducted on 101 patients admitted to the hospital with confirmed severe COVID-19. Most participants had less than 14 days from symptoms onset and less than seven days from hospitalization. Fifty patients were assigned to receive CP plus standard therapy (ST), and 51 were assigned to receive ST alone. Participants in the CP arm received two doses of 250 mL each, transfused 24 h apart. All transfused plasma was obtained from "super donors" that fulfilled the following criteria: titers of anti-SARS-CoV-2 S1 IgG ≥ 1:3200 and IgA ≥ 1:800 antibodies. The effect of transfused anti-IFN antibodies and the SARS-CoV-2 variants at the entry of the study on the overall CP efficacy was evaluated. The primary outcomes were the reduction in viral load and the increase in IgG and IgA antibodies at 28 days of follow-up. The per-protocol analysis included 91 patients.
Results: An early but transient increase in IgG anti-S1-SARS-CoV-2 antibody levels at day 4 post-transfusion was observed (Estimated difference [ED], - 1.36; 95% CI, - 2.33 to - 0.39; P = 0.04). However, CP was not associated with viral load reduction in any of the points evaluated. Analysis of secondary outcomes revealed that those patients in the CP arm disclosed a shorter time to discharge (ED adjusted for mortality, 3.1 days; 95% CI, 0.20 to 5.94; P = 0.0361) or a reduction of 2 points on the WHO scale when compared with the ST group (HR adjusted for mortality, 1.6; 95% CI, 1.03 to 2.5; P = 0.0376). There were no benefits from CP on the rates of intensive care unit admission (HR, 0.82; 95% CI, 0.35 to 1.9; P = 0.6399), mechanical ventilation (HR, 0.66; 95% CI, 0.25 to 1.7; P = 0.4039), or mortality (HR, 3.2; 95% CI, 0.64 to 16; P = 0.1584). Anti-IFN antibodies and SARS-CoV-2 variants did not influence these results.
Conclusion: CP was not associated with viral load reduction, despite the early increase in IgG anti-SARS-CoV-2 antibodies. However, CP is safe and could be a therapeutic option to reduce the hospital length of stay. Trial registration NCT04332835.
(© 2022. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje