The OakTree Study
A clinical research study for adolescents and adults with COVID-19
WHAT IS THE OakTree STUDY?
The OakTree Study is testing the effectiveness and safety of an investigational medication for COVID-19 called GS-5245 in adolescents and adults 12 to 64 years of age. Researchers want to see if GS-5245 can shorten the length of time people have COVID-19.
WHO CAN PARTICIPATE?
To be considered for the study, you must:
- Be 12 to 64 years of age or older.*
- Have tested positive for COVID-19 in the last 3 days.
- Have had COVID-19 symptoms for no more than 3 days.
- Not be at risk for developing serious disease.
- Not be currently hospitalized or require hospitalization.
Both vaccinated and unvaccinated people will be considered for this study. If you had a vaccine or booster, you must have received it more than 4 months before starting the study.
Additional criteria to participate in the study also apply.
*Adults will be enrolled in the study first. Adolescents 12 to 17 years of age will be eligible to join at a later date.
WHAT MEDICINE WILL I TAKE?
You will be placed by chance in a group to take either the study drug, GS-5245, or placebo. The placebo looks like GS-5245 but does not contain active medicine. This helps researchers better understand the effects of GS-5245. You and the study doctor will not know which group you are in. This helps keep the study fair.
How will I take the study drug (or placebo)?
You will take one tablet by mouth twice a day with or without food for 5 days.
What happens during the study?
The study lasts up to about 90 days with at least 6 in-person visits for tests and health checks. An additional 3 visits will take place virtually (video call) or over the telephone.
Permission
The study doctor will first review with you the Informed Consent Form, which contains all the details of the study. Think it over and ask any questions you have. If you agree to join, you will give your permission by signing the form. Participation is voluntary. If you decide to join the study, you can choose to stop participating at any time.
Screening
Next, to see if you qualify for the study, the study doctor will ask questions about your health and medical history and run some tests.
Study Treatment
You will be placed by chance into a group to take either the study drug GS-5245 or placebo for 5 days. Your first study visit and study treatment dose may occur on the same day as your screening visit.
GS-5245
Placebo
Follow-Up
After you finish your study treatment, you’ll have additional visits to check on your health.
WHAT TYPES OF TESTS WILL I HAVE AT STUDY VISITS?
At in-person visits, you will have tests to check your health. You will not have all of these tests at every visit.
Blood Pressure
Body Temperature
Breathing Rate
Heart Rate
Oxygen Level
Physical Exam
Weight and Height
Blood Test
COVID-19 Test (nasal swab)
Pregnancy test (if applicable)
You’ll also be asked to complete a questionnaire about your COVID-19 symptoms every day from Day 1 to Day 29, and then again on Day 60 and Day 90. Completion of these questionnaires during your participation is essential.
FIND A STUDY SITE
1700 Towne Avenue, Claremont, CA, 91711
1600 Glasgow Road, Fort Worth, TX, 76134
2220 Percy Machin Drive North, Little Rock, AR, 72114
2430 Centre Avenue, SE Albuquerque, NM, 87106
413 N Alafaya Trail, Orlando, FL, 32828
16215 N Tatum Boulevard, Phoenix, AZ, 85032
410 1st Street Southwest, Alabaster, AL, 35007
1301 N Portland Avenue, Oklahoma City, OK, 73107
2023 West Ogden Avenue, Chicago, IL, 60612
1600 Pryor Road, SW Atlanta, GA, 30315
Where can I go for more
information?
To learn more about the OakTree Study, contact +1 833-625-0921 and enter
study PIN 51055.