What side effects are associated with this type of intervention?

Common treatments for COVID-19, particularly antiviral agents like remdesivir, which inhibit viral replication, have several known side effects. Remdesivir is generally well-tolerated but can cause side effects such as nausea, elevated liver enzymes, and potential liver toxicity. Other antiviral agents may have similar side effects, including gastrointestinal symptoms (e.g., diarrhea), headaches, and potential kidney or liver function alterations. It is important to monitor patients for these adverse effects during treatment.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of COVID-19, focusing on inhibiting viral replication. Notably, remdesivir (Veklury) was one of the first antivirals to receive FDA approval for treating COVID-19. Additionally, nirmatrelvir combined with ritonavir (Paxlovid) has been authorized for emergency use to reduce severe outcomes in high-risk patients. These treatments aim to inhibit the replication of the SARS-CoV-2 virus, similar to the mechanism being studied for Obeldesivir.

What other types of research exist?

Promising novel alternatives to Obeldesivir for COVID-19 treatment include Tenofovir Disoproxil Fumarate plus Emtricitabine, which has shown to accelerate the clearance of SARS-CoV-2 viral burden in outpatients, and Remdesivir, which has demonstrated effectiveness in reducing the risk of hospitalizations and emergency department visits in high-risk COVID-19 outpatients. Additionally, HIV protease inhibitors and nucleos(t)ide RNA polymerase inhibitors are being appraised as potential candidates for antiviral treatment of SARS-CoV-2.

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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

Pivotal Trial

Summary

This trial is testing obeldesivir to see if it is safe and effective for treating COVID-19 in people who are not at high risk of severe illness. Researchers will also study how much of the drug enters the blood and how long it stays 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had COVID-19 symptoms for no more than 3 days.

Select...

I experience headaches.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to day 5 plus 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiviral treatments for COVID-19, such as Obeldesivir, work by inhibiting the replication of the SARS-CoV-2 virus. These drugs target specific viral enzymes, such as RNA-dependent RNA polymerase, which are essential for viral replication. By blocking these enzymes, antivirals prevent the virus from multiplying within the host cells, thereby reducing the viral load and helping the immune system to control the infection. This mechanism is crucial for COVID-19 patients as it can potentially shorten the duration of the illness, reduce the severity of symptoms, and lower the risk of complications, especially in high-risk populations.

COVID-19 Drug Treatment in China.Key summary of German national treatment guidance for hospitalized COVID-19 patients : Key pharmacologic recommendations from a national German living guideline using an Evidence to Decision Framework (last updated 17.05.2021).The Pipeline of Therapeutics Testing During the Emergency Phase of the COVID-19 Outbreak.