Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Filovirus Disease Postexposure Prophylaxis for Filovirus Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Obeldesivir (ODV)

Participants will receive ODV for 10 days

Group Type EXPERIMENTAL

obeldesivir

Intervention Type DRUG

Tablets administered orally

Interventions

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obeldesivir

Tablets administered orally

Intervention Type DRUG

Other Intervention Names

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GS-5245

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No