Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak

Clinical Trials : Journal of the Society for Clinical Trials
Tansy EdwardsEbola_Tx Consortium

Abstract

The Ebola virus disease outbreak in 2014-2015 led to a huge caseload with a high case fatality rate. No specific treatments were available beyond supportive care for conditions such as dehydration and shock. Evaluation of treatment with convalescent plasma from Ebola survivors was identified as a priority. We evaluated this intervention in an emergency setting, where randomization was unacceptable. The original trial design was an open-label study comparing patients receiving convalescent plasma and supportive care to patients receiving supportive care alone. The comparison group comprised patients recruited at the start of the trial before convalescent plasma became available, as well as patients presenting during the trial for whom there was insufficient blood group-compatible plasma or no staffing capacity to provide additional transfusions. However, during the trial, convalescent plasma was available to treat all new patients. The design was changed to use a comparator group comprising patients previously treated at the same Ebola treatment center prior to the start of the trial. In the analysis, it was planned to adjust for any differences in prognostic variables between intervention and comparison groups, specifically bas...Continue Reading

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Citations

Aug 31, 2016·The Journal of Infectious Diseases·Chad E MireThomas W Geisbert
Jan 18, 2017·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·Olivier Garraud
Jan 4, 2018·Reproductive Health·Melba F GomesAnnette C Kuesel
Oct 18, 2018·PLoS Neglected Tropical Diseases·Maya RonseKoen Peeters Grietens
Dec 14, 2016·The New England Journal of Medicine·Johan van GriensvenUNKNOWN Ebola-Tx Consortium
Feb 20, 2019·Health Security·Colleen S KraftChristopher J Kratochvil
Jan 6, 2021·International Journal of Antimicrobial Agents·Charles S Pavia, Gary P Wormser
Dec 7, 2019·Journal of Autoimmunity·Manuel RojasJuan-Manuel Anaya

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Methods Mentioned

BETA
PCR

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