The first patients have been enrolled in a treatment trial for the Bundibugyo strain of Ebola in the Democratic Republic of the Congo — a record pace that scientists say could not have been achieved without the hard-won clinical trial infrastructure built during previous outbreaks.
As of July 9, the outbreak had produced 1,792 confirmed cases and 625 deaths, making it the fastest-growing Ebola epidemic on record. The Bundibugyo strain is particularly challenging because there is no approved vaccine and no approved treatment for it. It typically kills about one in three of those infected.
The WHO declared the outbreak a public health emergency of international concern on May 17. Just six weeks later, the Partners treatment trial — sponsored by the WHO with funding from the Wellcome Trust, FCDO, and UKRI — opened its doors in Bunia, the capital of Ituri province, where the virus is raging.
The trial tests two drugs: remdesivir, an antiviral made by Gilead Sciences, and MBP134, a monoclonal antibody developed by Mapp Biopharmaceutical containing two engineered immune proteins that recognize and neutralize the virus. Patients are randomly allocated to receive either drug, a combination of both, or standard supportive care.
"These two drugs actually have been proven to work against the Bundibugyo virus in animal models," said Prof Laurens Liesenborghs of the Institute of Tropical Medicine in Antwerp, who is working on the trial. "They showed great efficacy, but now we need to test it in humans."
The trial's design is intentionally simple — modeled on the UK's Recovery trial during Covid — and allows other potential treatments to be added as they become available. An estimated 700 to 1,000 patients will need to be enrolled. Enough remdesivir and MBP134 have been donated for 1,200 patients.
Unusually, the trial includes pregnant and breastfeeding women, who are typically excluded from medical research. "Here the benefit is potentially very high because you offer a potentially life-saving treatment to someone who has a very high chance of dying," said Liesenborghs.
The response faces enormous challenges. About 75% of known contacts are being traced, but low trust in authorities and a highly mobile population are hampering efforts. Frontline workers have stopped work in protest at lack of pay, and some have been attacked by community members suspicious of outside intervention.
"Since we started working on 15 May, with all the insults we've had to put up with, we haven't seen a single penny," said Bahati John, head of a safe burial team, who lost a tooth after being attacked by local people.
Another trial is expected to begin soon, testing whether obeldesivir — a drug given to contacts of Ebola cases — can prevent them from developing the disease. Africa CDC said that trial needed around $18 million to proceed, with $6 million committed to date.
Prof Amanda Rojek of the University of Oxford, international principal investigator for Partners, called the six-week enrollment timeline "just fantastic." Comparing it to the 2014-16 West Africa outbreak, where it took over a year to start clinical trials, she credited the strong scientific leadership in the DRC, which has hosted major trials during previous outbreaks of Ebola and mpox.
