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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
Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date up to day 5 plus 30 days
Awards & highlights

BIRCH Trial Summary

This trial will test a drug to see if it's safe & effective for treating COVID-19, and measure how it moves through the body.

Eligible Conditions
  • COVID-19
  • Coronavirus

BIRCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You started showing symptoms of COVID-19 no more than 5 days ago.

BIRCH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COVID-19 Testing
Secondary 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
+10 more

BIRCH 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.

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
836,482 Total Patients Enrolled
21 Trials studying COVID-19
18,555 Patients Enrolled for COVID-19
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,362 Total Patients Enrolled
9 Trials studying COVID-19
9,004 Patients Enrolled for COVID-19

Media Library

GS-5245 Clinical Trial Eligibility Overview. Trial Name: NCT05603143 — Phase 3
COVID-19 Research Study Groups: Obeldesivir, Placebo
COVID-19 Clinical Trial 2023: GS-5245 Highlights & Side Effects. Trial Name: NCT05603143 — Phase 3
GS-5245 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603143 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment currently have any open slots for new participants?

"Yes, this study is still looking for enrollees. The trial was first announced on November 1st, 2022 and has since been updated October 31st, 2022. Up to 2300 patients can be recruited from a single location."

Answered by AI

How many test subjects are required for this clinical trial?

"That is correct. The clinical trial is currently active and recruiting patients. The listing was first posted on November 1st, 2020 and has since been updated on October 31st, 2020. They are looking for 2300 patients across 1 location."

Answered by AI

When might GS-5245 receive federal approval for use?

"Based on our team's expertise and analysis, we have determined that the GS-5245 medication is safe to use. This is due to the fact that it is a Phase 3 trial, which implies that there is data backing up its efficacy as well as its safety from multiple rounds of testing."

Answered by AI
~201 spots leftby Mar 2025