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Obeldesivir for COVID-19 (BIRCH Trial)
Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 5
Awards & highlights
Summary
This trial is testing a drug called obeldesivir to see if it can safely and effectively treat COVID-19 in people who are at higher risk of severe illness. The drug aims to stop the virus from multiplying, which could help patients get better more quickly.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and day 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 5
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
PK Parameter: Cmax of GS-441524
PK Parameter: Ctau of GS-441524
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524
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: PlaceboPlacebo Group1 Intervention
Participants will receive placebo twice daily for 5 days.
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Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,098 Previous Clinical Trials
860,001 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
351 Previous Clinical Trials
188,892 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You started showing symptoms of COVID-19 no more than 5 days ago.You are not currently in the hospital or in need of hospitalization.You understand the study and agree to sign a form saying you want to participate.You have been confirmed to have COVID-19 within the 5 days before the randomization.You are eligible to participate if you have at least one risk factor for getting very sick from the disease, or two risk factors if you are vaccinated. If you are vaccinated, you must wait at least 4 months since your last dose, including boosters.
Research Study Groups:
This trial has the following groups:- Group 1: Obeldesivir
- Group 2: 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.
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