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N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea.

Author information

1
From the Institute of Tropical Medicine, Antwerp (J.G., K.F., J.B., R.R., Y.C., M.D.C., L.L., A.D.W.), Médecins sans Frontières, Brussels (A.A., C.L.), and the Clinical Pharmacology and Pharmacotherapy Department, Katholieke Universiteit Leuven, Leuven (R.R.) - all in Belgium; Medical Research Council Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London (T.E., P.G.S.), Institute of Translational Medicine and National Institute for Health Research (NIHR) Health Protection Research Unit in Emerging and Zoonotic Infections, University of Liverpool, Liverpool (M.G.S.), and Centre for Tropical Medicine and Global Health, University of Oxford, Oxford (P.W.H.) - all in the United Kingdom; Aix Marseille University (X.L., P.G.), French Institute of Research for Development (X.L.), École des Hautes Études en Santé Publique (X.L.), and Institut Hospitalo-Universitaire Méditerranée Infection (X.L., P.G.), Marseille, Etablissement Français du Sang, La Plaine Saint Denis (P.G., P.T.), Unité de Biologie des Infections Virales Emergentes, Institut Pasteur, Centre International de Recherche en Infectiologie (S.B.), Laboratoire P4 INSERM-Jean Mérieux (H.R.), Lyon, and Université de Franche Comté, Etablissement Français du Sang, INSERM UMR 1098, Besançon (P.T.) - all in France; Laboratory of Viral Hemorrhagic Fever, Gamal Abdel Nasser University of Conakry (N.M.), Service des Maladies Infectieuses et Tropicales de l'Hôpital National Donka, Conakry (E.I.B.), National Blood Transfusion Center (N.H.), Conakry, and National Center for Training and Research in Rural Health of Maferinyah, Forecariah (A.D.) - all in Guinea; and Institut Pasteur de Dakar, Dakar, Senegal (O.F., A.A.S.).

Abstract

BACKGROUND:

In the wake of the recent outbreak of Ebola virus disease (EVD) in several African countries, the World Health Organization prioritized the evaluation of treatment with convalescent plasma derived from patients who have recovered from the disease. We evaluated the safety and efficacy of convalescent plasma for the treatment of EVD in Guinea.

METHODS:

In this nonrandomized, comparative study, 99 patients of various ages (including pregnant women) with confirmed EVD received two consecutive transfusions of 200 to 250 ml of ABO-compatible convalescent plasma, with each unit of plasma obtained from a separate convalescent donor. The transfusions were initiated on the day of diagnosis or up to 2 days later. The level of neutralizing antibodies against Ebola virus in the plasma was unknown at the time of administration. The control group was 418 patients who had been treated at the same center during the previous 5 months. The primary outcome was the risk of death during the period from 3 to 16 days after diagnosis with adjustments for age and the baseline cycle-threshold value on polymerase-chain-reaction assay; patients who had died before day 3 were excluded. The clinically important difference was defined as an absolute reduction in mortality of 20 percentage points in the convalescent-plasma group as compared with the control group.

RESULTS:

A total of 84 patients who were treated with plasma were included in the primary analysis. At baseline, the convalescent-plasma group had slightly higher cycle-threshold values and a shorter duration of symptoms than did the control group, along with a higher frequency of eye redness and difficulty in swallowing. From day 3 to day 16 after diagnosis, the risk of death was 31% in the convalescent-plasma group and 38% in the control group (risk difference, -7 percentage points; 95% confidence interval [CI], -18 to 4). The difference was reduced after adjustment for age and cycle-threshold value (adjusted risk difference, -3 percentage points; 95% CI, -13 to 8). No serious adverse reactions associated with the use of convalescent plasma were observed.

CONCLUSIONS:

The transfusion of up to 500 ml of convalescent plasma with unknown levels of neutralizing antibodies in 84 patients with confirmed EVD was not associated with a significant improvement in survival. (Funded by the European Union's Horizon 2020 Research and Innovation Program and others; ClinicalTrials.gov number, NCT02342171.).

PMID:
26735992
PMCID:
PMC5856332
DOI:
10.1056/NEJMoa1511812
[Indexed for MEDLINE]
Free PMC Article

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