The content of this website is intended for United States audiences only.

Report an Adverse Event
/-/media/project/gileadclinicaltrial/header/arrow-right-img.svg
Back Arrow Back to search results
Global Share

STATUS Will Be Recruiting

Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease

LAST UPDATED

December 01 2025

Clinicaltrials.gov ID

NCT06682234

OVERVIEW

A Phase 2, Single-Arm Study of Obeldesivir for Postexposure Prophylaxis of Filovirus Diseases

PROTOCOL SUMMARY

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Filovirus disease in participants with known or suspected exposure to Filovirus disease. The primary objective is to evaluate the safety and tolerability of ODV for Ebola virus (EBOV), Sudan virus (SUDV), and MARV postexposure prophylaxis (PEP).

View More

Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Filovirus Disease, Postexposure Prophylaxis for Filovirus Disease

Gender

N/A

Date

December 2025 - December 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

obeldesivir

Eligibility Information

Inclusion

Inclusion Criteria

  • Able to understand and give written informed consent and comply with treatment and follow up.
  • Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  • Known or suspected high-risk exposure to Ebola virus (EBOV), Sudan virus (SUDV), or Marburg virus (MARV) within 21 days of Day 1. High-risk exposure may include the following:
  • 1. Direct contact with bodily fluids from a confirmed case.
  • 2. Needle stick injury with a needle potentially contaminated with virus.
  • 3. Prolonged exposure to an individual with EBOV, SUDV, or MARV infection or disease without (adequate) personal protective equipment.
VIEW MORE
Exclusion

Exclusion Criteria

  • Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.
  • Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.
  • Known EBOV, SUDV, or MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic filovirus disease as attributed by the investigator.
  • Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.
  • Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset [< 2 weeks] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
VIEW MORE