Trial protocol

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

For further information, please consult :
Clinicaltrials
PACTR

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.

protocole EBo pEP

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.

–

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 and breastfeeding 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

  • Age <12 years
  • Pregnant or positive pregnancy test
  • Women with plans to breastfeed during the study period and 21 days following the last dose
    of study intervention.
  • Last high-risk contact within the last 5 days with a BDBV PCR confirmed case,

–

Provisional calendar

2026

July 2026

Start of enrollment

2026-2028
  • Planned enrollment duration: 2 years
  • Maximum follow-up duration per trial participant: 42 days
2028

July 2028

Scheduled date for the final participant’s last visit (this date may be brought forward depending on the scale of the outbreak).