Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease

Gilead Sciences

Status and phase

Not yet enrolling

Phase 2

Conditions

Postexposure Prophylaxis for Filovirus Disease

Filovirus Disease

Treatments

Drug: obeldesivir

Study type

Interventional

Funder types

Industry

Identifiers

NCT06682234

GS-US-719-7450

Details and patient eligibility

About

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).

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.