Researchers in the Democratic Republic of Congo have begun enrolling participants in a clinical trial testing Gilead Sciences’ experimental antiviral obeldesivir as a post-exposure treatment during the Bundibugyo Ebola outbreak affecting Congo and Uganda.
The study is being led by Congo’s National Institute for Biomedical Research and France’s ANRS Emerging Infectious Diseases, with support from the Alliance for International Medical Action and Médecins Sans Frontières.
The trial is taking place in Congo’s Ituri province, the epicentre of the outbreak, according to a joint statement issued by the organisations on Tuesday.
Researchers aim to determine whether obeldesivir can reduce the risk of infection among people recently exposed to the Ebola virus.
The study is expected to enrol about 1,000 participants aged 12 and older who experienced high-risk contact with a confirmed Ebola patient within the previous five days but have not developed symptoms.
Participants will be checked daily for 21 days and undergo a final follow-up assessment after 42 days.
Obeldesivir has demonstrated activity against filoviruses, the family of viruses that includes Ebola, in preclinical studies. The drug has not yet been approved as a treatment for Bundibugyo Ebola.
The project has received an initial €3.4 million, equivalent to about $3.87 million, from the European Commission-supported Global Health EDCTP3 partnership. The Africa Centres for Disease Control and Prevention has provided another $1 million.
Africa CDC also helped secure commitments for an additional $5 million from the governments of South Africa and the Democratic Republic of Congo.
A separate compassionate-use programme will provide Gilead’s injectable antiviral remdesivir to exposed children younger than 12, as well as pregnant and breastfeeding women who are not eligible for the main trial.
The outbreak has resulted in 1,963 confirmed infections and 719 deaths in Congo, according to government figures.