A trial to test two antiviral therapies on patients with Ebola Bundibugyo Virus started to enrol patients on Thursday – but its exact location in the Democratic Republic of Congo’s (DRC) Ituri province remains secret for security reasons.

This emerged at a World Health Organization (WHO) briefing on Thursday, at which Director General Dr Tedros Adhanom Ghebreyesus revealed yet another Ebola treatment centre in Ituri had been attacked in the past week.

Citing “mistrust and violence” as significant obstacles to addressing the Ebola outbreak, Tedros said that the attack had resulted in the deaths of two people, the centre being set on fire and patients fleeing.

The attack related to the burial of a community member who had died of Ebola, added Dr Chikwe Ihekweazu, WHO’s executive director of health emergencies.

There were 1,406 confirmed Ebola cases and 438 deaths by 30 June, a case fatality rate of over 31%, according to the DRC’s health ministry.

‘Record time’

The PARTNERS trial will assess whether the antivirals, a monoclonal antibody called MBP134 and remdesivir, can improve the outcome and survival rate of people with Ebola in Bundibugyo. It will also evaluate whether combining the two antivirals provides additional benefits.

The WHO-sponsored trial is being coordinated by the DRC’s Institut National pour la Recherche Biomédicale (INRB), the Institute of Tropical Medicine in Belgium, and the University of Oxford in the United Kingdom.  

These two treatments were selected by the WHO Technical Advisory Group “after a thorough review of scientific evidence, including preclinical research and safety data, and evidence from previous outbreak responses”, said the WHO in a statement. 

It is a randomised, controlled trial that is enrolling patients of any age with confirmed Bundibugyo. Aside from the medicine, patients will receive “early supportive care, including oral or intravenous fluids, electrolyte replacement, oxygen support, blood pressure management, and pain control in line with WHO treatment guidelines”, according to the WHO.      

People enrolled in the trial will receive “close support and follow-up for at least 28 days after enrolment,” it added.

Tedros said that the trial had been assembled “in record time, [and] offers real hope that we can deliver concrete results for – and with – the communities at the heart of the outbreak.”

The trial has been established as a platform trial, which allows for additional treatments to be added as they become available following assessment by the WHO Technical Advisory Group.

INRB Director General Prof Jean-Jacques Muyembe-Tamfum, said that, “by integrating this trial into clinical care, we are giving patients access to promising investigational treatments while generating the evidence needed to improve care for current and future outbreaks. “

“One of the key lessons from recent outbreaks is that research needs to happen alongside the response, not after it,” said Professor Amanda Rojek, the trial lead from Oxford University’s Pandemic Sciences Institute. 

“The PARTNERS trial gives us an opportunity to evaluate potential treatments during the outbreak itself, so that the evidence generated can help inform patient care when it is needed most – in months rather than years,” said Rojek.

DRC Health Minister Samuel Kamba said that the trial demonstrated his country’s “strong commitment to science and research,” and it offered “renewed hope to patients, their families, and affected communities”. 

The trial will conclude once an independent data safety monitoring committee is confident about the results, said WHO R&D Blueprint lead Dr Vasee Moorthy.

“From what we see at the moment, this is going to take some time,” said Moorthy. “We shouldn’t expect that this is going to be over in weeks. It will take some months. It could go even into next year. It could be that we need over 1000 patients enrolled in the trial until we get a definitive answer or it could be earlier if there’s a very high efficacy from the trial.”

Moorthy added that “discussions with the community as absolutely central, because all this is about protecting the community”. 

The trial has “community advisory panels with representatives from all of the relevant trusted stakeholder groups on the ground, including healthcare workers, community leaders, faith groups, and other leaders”, he added.

Image Credits: DRC Ministry of Health.