Filovirus DiseasePhase 2NCT06682234
Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease
A Phase 2 study testing obeldesivir in people with Filovirus Disease and Postexposure Prophylaxis for Filovirus Disease, run by Gilead Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Filovirus Disease, Postexposure Prophylaxis for Filovirus Disease
- What is being tested?
- obeldesivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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).
- Being tested
- obeldesivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obeldesivirDrug
Also called GS-5245
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Obeldesivir (ODV) | Experimental | Participants will receive ODV for 10 days Receives: Drug: obeldesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Measured: First dose date up to 29 Days
Secondary outcomes (3)
Proportion of Participants with Symptomatic Filovirus Disease by Day 29
Measured: Up to 29 Days
Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed Filovirus Disease Infections by Day 29
Measured: Up to 29 Days
Proportion of Participants with All-Cause Death by Day 29
Measured: Up to 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startDec 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: The study was withdrawn after the Marburg outbreak in Rwanda was declared over, prior to enrollment of any participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Filovirus DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682234
- Sponsor's protocol ID
- GS-US-719-7450
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm Study of Obeldesivir for Postexposure Prophylaxis of Filovirus Diseases
- ClinicalTrials.gov ID
- NCT06682234
- Acronym / sponsor ID
- GS-US-719-7450
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn after the Marburg outbreak in Rwanda was declared over, prior to enrollment of any participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obeldesivir (ODV) | Experimental | Drug: obeldesivirParticipants will receive ODV for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obeldesivirAlso: GS-5245Tablets administered orally | Drug | Obeldesivir (ODV) |
Primary outcome
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose date up to 29 Days
3 secondary outcomes
Proportion of Participants with Symptomatic Filovirus Disease by Day 29
Time frame: Up to 29 Days
Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed Filovirus Disease Infections by Day 29
Time frame: Up to 29 Days
Proportion of Participants with All-Cause Death by Day 29
Time frame: Up to 29 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing obeldesivir in people with Filovirus Disease and Postexposure Prophylaxis for Filovirus Disease, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Serious Adverse Events (SAEs) (time frame: First dose date up to 29 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.