Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease

NCT06682234 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: GS-US-719-7450
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Filovirus Disease; Postexposure Prophylaxis for Filovirus Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Experiencing Serious Adverse Events (SAEs)

  First dose date up to 29 Days

Secondary Outcomes (3)

• 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

• Proportion of Participants with All-Cause Death by Day 29

  Up to 29 Days

Study Arms (1)

Obeldesivir (ODV)

EXPERIMENTAL

Participants will receive ODV for 10 days

Drug: obeldesivir

Interventions

obeldesivir DRUG

Tablets administered orally

Also known as: GS-5245

Obeldesivir (ODV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Direct contact with bodily fluids from a confirmed case.
• Needle stick injury with a needle potentially contaminated with virus.
• Prolonged exposure to an individual with EBOV, SUDV, or MARV infection or disease without (adequate) personal protective equipment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Related Links

• Gilead Clinical Trials Website

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share