The EBO-PEP project
Full trial title:
Evaluation of the efficacy of a post-exposure prophylaxis (PEP) strategy in contacts at high risk of developing a Filovirus Disease: an adaptive platform trial
Short title – Sponsor Trial Number: INRB ANRS 0515s EBO-PEP trial
Sponsor: INRB
Co-sponsor: Inserm – ANRS MIE
Coordinating Investigators
Pr. Placide Mbala
Institut National de Recherche Biomédicale (INRB)
Avenue de la démocratie, Kinshasa Gombe, République Démocratique du Congo
Dr. Marie Jaspard
Hôpital Saint-Antoine, Service des maladies infectieuses et tropicales,
Inserm UMR-1136 IPLESP
184 rue Faubourg Saint-Antoine, 75012, Paris, France
Pr. Pauline Byakika-Kibwika
Mbarara University of Science and Technology (MUST)
P. O Box 1410, Mbarara, Uganda
Methodology
EBO-PEP is a randomized, controlled platform trial designed to evaluate different post-exposure prophylaxis strategies in contacts of individuals with filovirus disease (FVD). Treatment comparisons may use flexible methodological approaches and are described in sub-protocols appended to a master protocol. Each sub-protocol is named according to the investigational medicinal product (IMP) under evaluation and the targeted filovirus species (e.g., the “Obeldesivir–BDBV Sub-protocol”).
Participating countries: Countries with a declared outbreak of Filovirus Disease (FVD)
Interventions : Participants are individually randomized to different interventions depending on the virus and available option for Post-Exposure Prophylaxis (PEP) at a specific outbreak.
Trial follow-up: The total follow-up duration for trial participants is 42 days or end of Ebola Treatment Center (ETC) hospitalization for FVD confirmed cases.
All participants are followed daily for a minimum of 21 days.
Definition of high risk exposure
- Direct contact with a person with PCR-confirmed EVD presenting diarrhea, vomiting, or external hemorrhage (“wet symptoms”), or with their bodily fluids
- Direct contact with the body of a person with confirmed or probable EVD
- Needlestick injury with a syringe contaminated with the blood of a person with confirmed or probable EVD
Inclusion criteria
- Registered contact of an Filoviruses Disease (FVD) confirmed case;
- No sign or symptoms of FVD;
- Signed and dated informed consent to participate in the trial from the adult participant or their legal guardian in the case of a minor participant or adult with cognitive disorder.
Sub-protocol Obeldesevir - BDVD Planned enrollment
494 participants per study arm
A total of 998 participants
Sub-protocol n°1 EBO-PEP ODV-BDBV
The investigational medicinal products (IMP) proposed for evaluation in EBO-PEP ODV-BDBV is Obeldesivir
EBO-PEP ODV-BDBV use a double-blind, placebo-controlled, superiority design with two parallel arms, to evaluate the safety and efficacy of ODV vs. Placebo in preventing symptomatic BVD in participants with high-risk contact.
Participants will be individually randomized (1:1) between two arms:
- Placebo
- Obeldesivir (ODV)
An interim analysis will be planned at mid-recruitment to assess:
- early efficacy,
- futility,
- and reassess the required sample size if needed.
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Sub-protocol n°2 EBO-PEP RDV-BDBV
The EBO-PEP RDV-BDBV sub-protocol describes a prospective interventional cohort evaluating the administration of remdesivir for the prevention of symptomatic Bundibugyo ebolavirus disease (BVD) in children, as well as in pregnant women who have had high-risk exposure.
The cohort is conducted in parallel with the EBO-PEP ODV-BDBV sub-protocol and targets the population most vulnerable to Ebola virus disease.
Specific inclusion criteria
- Weight < 20 kg
- Pregnant or positive pregnancy test
- Last high-risk contact within the last 5 days with a BDBV PCR confirmed case
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Provisional calendar
July 2026
Start of enrollment
- Planned enrollment duration: 2 years
- Maximum follow-up duration per trial participant: 42 days
July 2028
Scheduled date for the final participant’s last visit (this date may be brought forward depending on the scale of the outbreak).