ANRS 0515s EBO-PEP

Objectives of EBO-PEP

Multicenter, multi-epidemic, phase III, comparative, controlled, randomized, one-sided, superiority trial with two parallel, unblinded
arms.

Main objective

• Compare the rate of EVD at 21 days in contacts at high-risk of EVD receiving a PEP strategy of ERV+IMZ vs. ERV alone.

Secondary objectives

• Compare the rate of EVD at 60 days in contact at high-risk of EVD receiving a PEP strategy with ERV+IMZ versus ERV alone
• Compare safety and tolerance between the different trial arms
• Compare EVD severity between the different trial arms
• Compare the rate of asymptomatic EVD between the different trial arms
• Compare the proportion of deaths between the different trial arms
• Describe the evolution of viral load in the different trial arms
• Estimate the cost-effectiveness ratio in the different trial arms

Criteria

Inclusion criteria

• Last high-risk contact within the last 5 days
• No sign or symptoms of EVD
• Signed and dated informed consent from participants over the age of majority in order to participate in the trial or from a representative of parental authority for minor participants

Primary endpoint

• Proportion of participants with EBOV PCR-confirmed symptomatic EVD between D1 and D21.