The first patients have been enrolled in a record-breaking Ebola treatment trial in the Democratic Republic of the Congo (DRC), just six weeks after the outbreak was declared a public health emergency of international concern by the World Health Organization (WHO) on May 17.
The trial, which is being conducted at a record pace, aims to find an effective treatment for the Bundibugyo strain of the virus, for which there is no vaccine and no approved treatment. As of July 9, there had been 1,792 confirmed cases and 625 deaths caused by the virus, which is still in the expansion phase, according to the WHO.
The response to the outbreak has been hampered by low trust in authorities and a highly mobile population, with about 75% of known contacts being traced. Frontline workers have also stopped work in protest at a lack of pay, and the closure of the local airport in Bunia has impeded the supply of banknotes.
The Partners treatment trial has opened with two drugs on its books - remdesivir and MBP134. Patients will be randomly allocated to receive either drug, a combination of the two, or simply standard, supportive care. Remdesivir is an antiviral made by pharma company Gilead Sciences, while MBP134 is a monoclonal antibody developed by Mapp Biopharmaceutical.
Both drugs have been proven to work against the Bundibugyo virus in animal models, and researchers are watching carefully for any difference in death rates between the groups given experimental drugs and the group receiving standard care. The trial’s design allows other potential treatments to be added should they become available, and a result is likely to need between 700 and 1,000 patients to be enrolled.
Patients of any age, including pregnant and breastfeeding women, can enroll in the trial, and the WHO is in discussions to ensure sufficient supplies will be available after the trial, should the drugs prove safe and effective.
The trial is sponsored by the WHO, with funding from the Wellcome Trust, FCDO, and UKRI. Another trial is due to begin this week, looking at whether giving people who have been in contact with Bundibugyo cases a drug called obeldesivir can stop them developing the disease.
Africa CDC said that trial needed around $18m to proceed, with $6m committed to date. Prof Yap Boum, head of emergency response with continental health watchdog Africa CDC, warned that the danger was not over, but added that the trials will enable access to treatment and send a message to the community.
