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0 0.5 1 1.5 2+ Mortality -220% Improvement Relative Risk Discharge 38% Viral clearance, day 4 -25% Viral clearance, day 7 -16% Viral clearance, day 14 -51% Viral clearance, day 28 -12% Rojas et al. NCT04332835 Conv. Plasma RCT LATE TREATMENT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 91 patients in Colombia (August - November 2020) Higher discharge with convalescent plasma (p=0.038) Rojas et al., BMC Infectious Diseases, doi:10.1186/s12879-022-07560-7 Favors conv. plasma Favors control
Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study
Rojas et al., BMC Infectious Diseases, doi:10.1186/s12879-022-07560-7, NCT04332835 (history)
Rojas et al., Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel,.., BMC Infectious Diseases, doi:10.1186/s12879-022-07560-7, NCT04332835
Jun 2022   Source   PDF  
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RCT 91 hospitalized patients in Colombia showing shorter time to discharge with convalescent plasma, but higher mortality (without statistical significance).
risk of death, 220.0% higher, HR 3.20, p = 0.16, treatment 46, control 45, Cox proportional hazards.
risk of no hospital discharge, 37.5% lower, HR 0.62, p = 0.04, treatment 46, control 45, inverted to make HR<1 favor treatment, Cox proportional hazards.
risk of no viral clearance, 25.0% higher, OR 1.25, p = 0.72, treatment 46, control 45, adjusted per study, mid-recovery, day 4, RR approximated with OR.
risk of no viral clearance, 16.0% higher, OR 1.16, p = 0.82, treatment 46, control 45, adjusted per study, day 7, RR approximated with OR.
risk of no viral clearance, 51.0% higher, OR 1.51, p = 0.60, treatment 46, control 45, adjusted per study, day 14, RR approximated with OR.
risk of no viral clearance, 12.0% higher, OR 1.12, p = 0.91, treatment 46, control 45, adjusted per study, day 28, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rojas et al., 27 Jun 2022, Single Blind Randomized Controlled Trial, Colombia, peer-reviewed, 45 authors, study period 8 August, 2020 - 13 November, 2020, average treatment delay 11.0 days, trial NCT04332835 (history).
Contact: (corresponding author).
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This PaperConv. PlasmaAll
Abstract: (2022) 22:575 Rojas et al. BMC Infectious Diseases Open Access RESEARCH Safety and efficacy of convalescent plasma for severe COVID‑19: a randomized, single blinded, parallel, controlled clinical study Manuel Rojas1,2, Yhojan Rodríguez3, Juan Carlos Hernández4, Juan C. Díaz‑Coronado5, José Alejandro Daza Vergara6, Verónica Posada Vélez7, Jessica Porras Mancilla7, Iván Araujo5, Jairo Torres Yepes6, Oscar Briceño Ricaurte6, Juan Mauricio Pardo‑Oviedo6, Diana M. Monsalve3, Yeny Acosta‑Ampudia3, Carolina Ramírez‑Santana3, Paula Gaviria García8, Lina Acevedo Landinez8, Luisa Duarte Correales8, Jeser Santiago Grass8, Cristian Ricaurte Pérez8, Gustavo Salguero López8, Nataly Mateus4, Laura Mancera4, Ronald Rengifo Devia4, Juan Esteban Orjuela4, Christian R. Parra‑Moreno4, Andrés Alfonso Buitrago4, Inés Elvira Ordoñez4, Claudia Fabra Osorio7, Nathalia Ballesteros9, Luz H. Patiño9, Sergio Castañeda9, Marina Muñoz9, Juan David Ramírez9,10, Paul Bastard11,12,13,14, Adrian Gervais13,15, Lucy Bizien13,15, Jean‑Laurent Casanova12,13,14,16,17,18, Bernardo Camacho8, Juan Esteban Gallo19, Oscar Gómez19, Adriana Rojas‑Villarraga20, Carlos E. Pérez21, Rubén Manrique22, Rubén D. Mantilla3 and Juan‑Manuel Anaya3,23* Abstract 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 *Correspondence: 23 Present Address: LifeFactors, Rionegro, Colombia Full list of author information is available at the end of the article © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as..
Late treatment
is less effective
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