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Antiviral

Obeldesivir for COVID-19

Phase 2 & 3

Waitlist Available

Research Sponsored by Gilead Sciences

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1 and 2: day 3 and 5 for reporting.

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 more

Secondary 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 more

Trial 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.

0 / 1Eligibility criteria met

Find a Location

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

Recent research and studies

clinicaltrials.govStudy

Study of Obeldesivir in Children and Adolescents With COVID-19

2023. "Study of Obeldesivir in Children and Adolescents With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996744.

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