Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Filovirus Disease; Postexposure Prophylaxis for Filovirus Disease
• Intervention / Treatment: Drug: obeldesivir

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obeldesivir (ODV); Participants will receive ODV for 10 days	Drug: obeldesivir; Tablets administered orally; Other Names: GS-5245

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing Serious Adverse Events (SAEs)	First dose date up to 29 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants with All-Cause Death by Day 29	Up to 29 Days
Proportion of Participants with Symptomatic Filovirus Disease by Day 29	Up to 29 Days
Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed Filovirus Disease Infections by Day 29	Up to 29 Days

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Mononegavirales Infections; Filoviridae Infections; Virus Diseases; Marburg Virus Disease
• Other Study ID Numbers: GS-US-719-7450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes