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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohorts 1 and 2: day 3 and 5
Awards & highlights
Study Summary
This trial will investigate the safety and effectiveness of an antiviral drug (ODV) in children and adolescents with COVID-19.
Who is the study for?
This trial is for children and adolescents with COVID-19 who started showing symptoms within the last 5 days. They must have at least one symptom like fever or cough, be at risk of severe illness, meet specific weight and age criteria, and have a confirmed SARS-CoV-2 infection. Those previously treated for COVID-19 or vaccinated less than 4 months ago cannot participate.Check my eligibility
What is being tested?
The study tests Obeldesivir (ODV) to see how safe it is for kids with COVID-19 and how their bodies handle the drug. It looks at side effects and measures the levels of ODV in their blood over time.See study design
What are the potential side effects?
While not explicitly listed in your provided information, potential side effects may include reactions similar to other antiviral drugs such as nausea, diarrhea, headache, dizziness, or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I started showing COVID-19 symptoms like fever or cough less than 5 days ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohorts 1 and 2: day 3 and 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohorts 1 and 2: day 3 and 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK Parameter: Cmax of ODV Metabolite, GS-441524
PK Parameter: Ctrough of ODV Metabolite, GS-441524
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
+2 moreSecondary outcome measures
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores
Proportion of Participants Who Require Supplemental Oxygen Support by Day 35
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Obeldesivir (ODV)Experimental Treatment1 Intervention
Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows:
Cohort 1: ODV, tablets, 350 mg twice daily (BID)
Cohort 2: ODV, tablets, 175 mg BID
Cohorts 3-7: ODV doses will be determined based on available PK data.
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Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,259 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,690 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities for participation in this research project?
"Affirmative. Clinicaltrials.gov confirms that this medical experiment, which was first posted on October 1st 2023, is actively enlisting individuals for participation. Around 52 patients need to be recruited across 2 distinct clinical locations."
Answered by AI
What is the total number of participants involved in this clinical experiment?
"Affirmative. Clinicaltrials.gov has information that demonstrates this medical study, which was initially advertised on October 1st 2023, is presently seeking participants. Approximately 52 patients need to be enrolled from two separate healthcare facilities."
Answered by AI
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