Update: Ebola convalescent plasma study in Sierra Leone
Dr Calum Semple is a Senior Lecturer & Consultant Respiratory Paediatrician at the Institute of Translational Medicine, University of Liverpool, and is a member of the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections.
Around the country Ebola Medals are being received by British Volunteers, Armed Services staff and Research Teams who contributed to the Ebola Response in West Africa. Ebola is no longer in the daily news. But Ebola has not left West Africa. There is a cluster of at least three cases in Liberia, which was previously declared free of Ebola transmission on 3 September 2015. In Liberia in October a sixteen year old girl presented to health services after being unwell for several days in the Bombali district of Sierra Leone. She deteriorated rapidly and died overnight. This in an area that had been free of Ebola for 160 days. Guinea had continued to have cases at least through to 18th November.
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There have been only a few trials of therapeutic interventions for Ebola Virus Disease. The challenges of conducting trials in this context meant some research groups chose designs that relied upon historic controls, were not blinded or used a predefined outcome. These decisions have been criticised in various editorials but I doubt these critics could do better. I observed the best and worst of behaviour by researchers. There were a few good examples of co-operation between research groups, sharing protocols, outcome measures and even data. Yet the presence of one particular drug study in Sierra Leone caused a inexplicable perturbation in the usual pathway of admissions of ebola patients away from their closest Ebola Treatment Unit (ETU) to the ETU running that drug study, starving two other trails of patients. Some research teams worked on a basis of training and mentoring local investigators and left a legacy of improved capacity and facilities. Others just collect data, samples and left without a care.
I am optimistic that the Ebola crisis is nearly over. The
studies of Convalescent Plasma that I am involved in (Ebola_Tx in Guinea and
Ebola_CP in Sierra Leone) are winding up. Our study in Guinea is closed and we
hope the first results will be published soon. For that study we have been
careful to disclose the result to the local authorities and policy makers in
advance of publication to avoid any surprises and manage expectations. In
Sierra Leone we remain open to recruit in the event of resurgence and have
capacity to mobilise the plasma under trial conditions to any willing ETU. Our
trial team including transfusion technicians took part in a dry run of the
Rapid Deployment Isolation Facility in partnership with the UK MoD. We brought
frozen saline up from Freetown to Benguela Hastings in cold chain and mocked up
the administration of plasma.
In Guinea and Liberia, convalescent plasma was produced
using a specially converted bus that contained the aphoresis machines and a
small laboratory. In Sierra Leone we chose instead to refurbish the existing
blood bank at the Connaught Hospital Freetown, install apheresis and UV
transillumination and provide a plasma freezer. All this equipment was required
anyway. It made no sense to bring this kit in for the study and not install it
for ongoing use. The refurbishment of the blood bank was extensive. Wooden
bench tops with cracked formica tops were torn out and replaced with stainless
steel. Air conditioning with redundancy to allow for breakdown and serving was
installed. The steps leading up the blood bank were retiled with non-slip
surfaces, and a lick of paint was added. Finally we rewired the building and
installed a massive lead acid battery uninterrupted power supply.
The investment at the blood bank has already proved
worthwhile. Freetown suffered a devastating flash flood in September. 1,000
houses were damaged, 3,000 people were displaced and unofficial reports claim
about 40 bodies were recovered from the water. The Connaught Hospital was
caught directly hit by the torrent. The operating theatres were flooded and
mains and generator power was lost. The Blood Bank fridges and freezers
remained under power preserving the precious blood, frozen plasma and our
research samples.
We don’t expect the trial in Sierra Leone to recruit to power, but we will complete the characterisation of the donors and continue to support the Safe Blood Service Sierra Leone.
I’d like to express my gratitude to the Clinical Team at The 34th Regiment Military Hospital Freetown, The Transfusion team at the Blood Bank Freetown, the Project Managers Gerry McCann and Lewis Matthews, and Clinical Leads Dr Christine Cole and Dr Janet Scott (IGH).
I’d like to express my gratitude to the Clinical Team at The 34th Regiment Military Hospital Freetown, The Transfusion team at the Blood Bank Freetown, the Project Managers Gerry McCann and Lewis Matthews, and Clinical Leads Dr Christine Cole and Dr Janet Scott (IGH).
Thanks to your team's effort, there's an African solution that's cost-effective, in-country and scalable, to quote a friend. Congratulations on a job VERY well done!
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