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Advancing Research for Potential Respiratory Syncytial Virus (RSV) Treatment

For over 35 years, Gilead has been focused on researching antiviral treatments that can make a difference in the lives of patients. We're always testing new medicines to make sure they're both safe and effective for people of all ages. Our goal is to find treatments for RSV to give patients and their families hope and confidence when it comes to treatment.

Gilead is currently enrolling adults in an RSV clinical trial

Every year in the US, RSV leads to about

60,000–160,000

hospitalizations and 6,000–10,000 deaths in adults 65 years or older

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58,000–80,000

hospitalizations and an estimated 100–300 deaths in children under 5 years old

Source: Centers for Disease Control and Prevention
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Gilead is currently enrolling children (under 5 years old) in an RSV clinical trial

Recruiting trials

STATUS Will Be Recruiting

Adult RSV

A phase 2 clinical trial evaluating the efficacy and safety of obeldesivir in nonhospitalized adults with acute RSV infection.

About RSV

What is RSV?

The RSV is a common virus that affects the nose, throat, lungs, and airways. RSV is transmitted through droplets when someone with the virus coughs, sneezes, or kisses. It's also possible to contract RSV by touching a surface that has the virus on it, and then touching the eyes, nose, or mouth. A person with RSV is most likely to spread the virus, or be contagious, during the first week after infection. RSV usually has mild symptoms that are like the common cold: congested or runny nose, dry cough, fever, sore throat, sneezing, and/or headache. However, in some people, RSV can be more serious. In most parts of the US, RSV season usually begins in November and goes through March.

Sources: National Foundation for Infectious Disease, Mayo Clinic, MedlinePlus

Understanding RSV risk and exploring clinical trial options

While anyone at any age is at risk of RSV, infants and older people have a higher risk of having a severe RSV infection and may need hospitalization.

Adults at high risk for severe RSV:

  • Over 60 years old
  • Have chronic heart or lung disease
  • Have weakened immune systems

If you are 18 years or older, have RSV, are not currently hospitalized, and are at high risk for severe RSV, you may be eligible for a study. Gilead is recruiting participants for an RSV study.

Children at high risk for severe RSV:

  • Premature infants
  • Infants under 12 months
  • Children under 2 years with chronic lung disease or congenital heart disease
  • Children with weakened immune systems
  • Children with neuromuscular disorders

If your child is under 5 years old, has RSV, and is not currently hospitalized, they may be eligible for a study. Gilead is recruiting participants for an RSV study.

Sources: Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention

RSV diagnosis

If RSV is suspected, laboratory tests may be suggested to confirm this diagnosis. The most common are the rapid antigen test and PCR test.

1 Rapid antigen test
  • Sample of fluid taken from the nose
  • Only effective in infants and younger children
2 PCR test
  • Swab taken from the nose
  • Should be used to test older children and adults

Timely RSV testing is especially important in infants and older adults because the doctor can confirm the cause of their symptoms and assess whether a treatment or clinical trial may be appropriate. If the test comes back positive, infants and older adults may need treatment in the hospital right away if they have more serious symptoms.

Sources: MedlinePlus, Centers for Disease Control and Prevention

RSV treatment and prevention

Currently, there are no FDA-approved oral medications for treatment available for RSV. To help prevent severe RSV, vaccines are available for older adults and pregnant people and monoclonal antibody products are available for infants and young children. But even after vaccination or immunization, adults, children, and infants can get RSV and may need treatment. Over-the-counter medications can help manage symptoms such as fever and discomfort. A doctor may recommend nasal saline drops or a suction tool to help clear up a stuffy nose. If an RSV infection becomes severe and requires hospitalization, oxygen or IV fluids may be needed for treatment. Mild RSV infections tend to clear up on their own in about 1 to 2 weeks without any treatment.

Sources: American Lung Association, Centers for Disease Control and Prevention

Your Questions Answered

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

YOUR QUESTIONS ANSWERED

FAQ Topic:
ALL Clinical Trial Basics Safety and Security Trial Terms Defined The Clinical Trial

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.
Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.
If you don’t qualify due to not meeting the trial criteria, you should check with your healthcare provider to seek other options.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.