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Obeldesivir for COVID-19 (OAKTREE Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Answer yes if you are not at risk for developing serious disease
Have you had COVID-19 symptoms for 3 days or less?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date up to day 5 plus 30 days
Awards & highlights
OAKTREE Trial Summary
This trial will test a drug to see if it's safe and effective to treat COVID-19 in people at standard risk of severe illness. It will also measure how it's absorbed/eliminated in the body.
Who is the study for?
This trial is for non-hospitalized individuals with COVID-19 who have symptoms like cough, fatigue, body aches, shortness of breath, headache or sore throat for no more than 3 days. Participants must have tested positive for COVID-19 recently and should not be at high risk of severe disease.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Obeldesivir in treating COVID-19. It will compare how people respond to Obeldesivir versus a placebo (a substance with no active drug). The study also looks at how the body processes the drug.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include reactions where the medication is administered, flu-like symptoms, gastrointestinal issues or allergic responses. Each person's reaction to the medication can vary.
OAKTREE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had COVID-19 symptoms for no more than 3 days.
Select...
I experience headaches.
OAKTREE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose date up to day 5 plus 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date up to day 5 plus 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Experiencing Laboratory Abnormalities
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
+1 moreSecondary outcome measures
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
PK Parameter: Cmax of GS-441524
PK Parameter: Ctau of GS-441524
+9 moreOAKTREE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ObeldesivirExperimental Treatment1 Intervention
Participants will receive obeldesivir 350 mg twice daily for 5 days.
Group II: Obeldesivir PlaceboPlacebo Group1 Intervention
Participants will receive obeldesivir placebo twice daily for 5 days.
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
841,579 Total Patients Enrolled
21 Trials studying COVID-19
17,074 Patients Enrolled for COVID-19
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
184,793 Total Patients Enrolled
9 Trials studying COVID-19
7,523 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience muscle or body aches.I have a cough.I experience shortness of breath.I experience headaches.I have a sore throat.Have you tested positive for COVID-19 in the last 3 days?Answer YES if you are NOT currently hospitalized?I have had COVID-19 symptoms for no more than 3 days.I often feel very tired or have low energy.Answer yes if you are not at risk for developing serious disease
Research Study Groups:
This trial has the following groups:- Group 1: Obeldesivir
- Group 2: Obeldesivir Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
COVID-19 Patient Testimony for trial: Trial Name: NCT05715528 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment accepting senior citizens as participants?
"This research is open to individuals who are at least 12 years old and have not surpassed their 64th birthday."
Answered by AI
Is my health profile compatible with this experiment?
"To participate in this coronavirus research, prospective participants should have been diagnosed with Covid-19 and be aged between 12 to 64. At the moment, around 1900 people are being accepted into the trial."
Answered by AI
Is there any capacity for new participants in this clinical research?
"Current reports from clinicaltrials.gov show that this medical trial is still searching for participants, which began on February 8th 2023 and had its most recent update at the end of the month."
Answered by AI
Has the FDA given their seal of approval for GS-5245?
"We at Power have assigned GS-5245 a score of 3, reflecting the clinical data in Phase 3 trials that supports its safety and efficacy."
Answered by AI
What are the venues where this experiment can be accessed?
"This trial has 12 facilities which are administering the treatment, including Palm Harbor Dermatology d/b/a TrueBlue Clinical Research in Brandon, Midway Immunology and Research Center in Fort Pierce, and Innovative Health in Hollywood. There are other 9 participating sites as well."
Answered by AI
How many individuals are enrolled in this experiment?
"The research trial, spearheaded by Gilead Sciences, necessitates 1,900 participants to meet their inclusion criteria. Clinical sites approved for the study include Palm Harbor Dermatology d/b/a TrueBlue Clinical Research in Brandon, Florida and Midway Immunology and Research Center in Fort Pierce, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Arizona
Texas
Other
What site did they apply to?
Emvenio - Phoenix
Emvenio - Oklahoma City
Emvenio - Fort Worth
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
1
0
Why did patients apply to this trial?
I live near it. To be in the study. I like to help people. Want to make a difference.
PatientReceived 2+ prior treatments
I want to help with Covid.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How is the trial conducted? How long do the screening take? What are the requirements for this trial?
PatientReceived no prior treatments
Is their any compensation from this trail? How long is it and how much is a compensation?
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Tulane University School of Medicine: < 24 hours
- Emvenio - Phoenix: < 24 hours
- Emvenio - Orlando: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
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