TY - JOUR
T1 - Safety and efficacy of convalescent plasma for severe COVID-19
T2 - a randomized, single blinded, parallel, controlled clinical study
AU - Rojas, Manuel
AU - Rodríguez, Yhojan
AU - Hernández, Juan Carlos
AU - Díaz-Coronado, Juan C.
AU - Vergara, José Alejandro Daza
AU - Vélez, Verónica Posada
AU - Mancilla, Jessica Porras
AU - Araujo, Iván
AU - Yepes, Jairo Torres
AU - Ricaurte, Oscar Briceño
AU - Pardo-Oviedo, Juan Mauricio
AU - Monsalve, Diana M.
AU - Acosta-Ampudia, Yeny
AU - Ramírez-Santana, Carolina
AU - García, Paula Gaviria
AU - Landinez, Lina Acevedo
AU - Correales, Luisa Duarte
AU - Grass, Jeser Santiago
AU - Pérez, Cristian Ricaurte
AU - López, Gustavo Salguero
AU - Mateus, Nataly
AU - Mancera, Laura
AU - Devia, Ronald Rengifo
AU - Orjuela, Juan Esteban
AU - Parra-Moreno, Christian R.
AU - Buitrago, Andrés Alfonso
AU - Ordoñez, Inés Elvira
AU - Osorio, Claudia Fabra
AU - Ballesteros, Nathalia
AU - Patiño, Luz H.
AU - Castañeda, Sergio
AU - Muñoz, Marina
AU - Ramírez, Juan David
AU - Bastard, Paul
AU - Gervais, Adrian
AU - Bizien, Lucy
AU - Casanova, Jean Laurent
AU - Camacho, Bernardo
AU - Gallo, Juan Esteban
AU - Gómez, Oscar
AU - Rojas-Villarraga, Adriana
AU - Pérez, Carlos E.
AU - Manrique, Rubén
AU - Mantilla, Rubén D.
AU - Anaya, Juan Manuel
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Convalescent plasma
KW - COVID-19
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85132959316&partnerID=8YFLogxK
U2 - 10.1186/s12879-022-07560-7
DO - 10.1186/s12879-022-07560-7
M3 - Artículo
C2 - 35761219
AN - SCOPUS:85132959316
SN - 1471-2334
VL - 22
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 575
ER -