July 14 (Reuters) – Researchers in the Democratic Republic of Congo said on Tuesday they have started enrolling participants in a trial testing Gilead Sciences’ experimental antiviral obeldesivir as a post-exposure treatment for the ongoing Bundibugyo Ebola outbreak in Congo and Uganda.
Congo’s National Institute for Biomedical Research and France’s ANRS Emerging Infectious Diseases — with support from humanitarian aid groups, Alliance for International Medical Action (ALIMA) and Medecins Sans Frontieres — are leading the trial in Ituri province, the epicentre of the outbreak, the agencies said in a joint statement.
Here are some details:
• The trial is designed to assess whether post-exposure treatment can reduce the risk of developing Ebola infection after contact with the virus.
• The study aims to enroll about 1,000 people aged 12 years and older, who had high-risk exposure to a confirmed Ebola case within the previous five days but have not developed symptoms.
• Participants will be monitored daily for 21 days, with a final follow-up at 42 days.
• Obeldesivir has shown activity against filoviruses, including the Bundibugyo Ebola virus, in pre-clinical studies.
• The project has received initial funding of 3.4 million euros ($3.87 million) from the Global Health EDCTP3 partnership supported by the European Commission, and $1 million from the Africa Centres for Disease Control and Prevention.
• Africa CDC also helped secure an additional $5 million in funding commitments from South Africa and the Democratic Republic of Congo.
• The study also includes a separate compassionate-use protocol under which Gilead’s injectable antiviral remdesivir would be given to children under 12 years and pregnant or breastfeeding women exposed to the virus.
• The outbreak has led to 1,963 confirmed cases in Congo, including 719 deaths, according to government data.
($1 = 0.8777 euros)
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)
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