Filovirus Disease, Postexposure Prophylaxis for Filovirus Disease
Conditions
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).
Interventions
DRUGobeldesivir
Tablets administered orally
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) | First dose date up to 29 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed