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Antiviral
Bemnifosbuvir for COVID-19
Phase 3
Waitlist Available
Research Sponsored by Atea Pharmaceuticals, Inc.
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 through day 29; day 1 through day 60
Awards & highlights
Study Summary
This trial will test if a drug, BEM, is safe & effective for adults who have COVID-19 & are at risk for severe disease. Participants will get BEM or a placebo & may also get standard of care for 60 days.
Who is the study for?
Adults with COVID-19 who are not hospitalized but at high risk for severe disease can join this trial. This includes older adults, those with certain chronic conditions or immunocompromising states, and residents of care homes. Participants must have a recent positive SARS-CoV-2 test and be experiencing symptoms.Check my eligibility
What is being tested?
The SUNRISE-3 trial is testing the effectiveness and safety of Bemnifosbuvir (BEM) compared to a placebo in preventing the progression of COVID-19 in high-risk outpatients. Patients will take BEM or placebo orally for 5 days alongside standard treatments.See study design
What are the potential side effects?
While specific side effects of Bemnifosbuvir are not detailed here, common antiviral side effects may include nausea, diarrhea, headache, dizziness, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 29; day 1 through day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 29; day 1 through day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects hospitalized for any cause or died due to any cause
Secondary outcome measures
Proportion of subjects hospitalized due to COVID-19 or died due to any cause
Proportion of subjects who died due to any cause
Proportion of subjects with COVID-19 symptom relapse
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bemnifosbuvir (BEM)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemnifosbuvir (BEM)
2023
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Atea Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
1,522 Total Patients Enrolled
4 Trials studying COVID-19
475 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken hydroxychloroquine or amiodarone in the last 3 months.You are 70 years or older, or 55 years or older with certain health conditions, or 50-54 years with specific health conditions, or 18 years or older with certain medical conditions or receiving certain treatments that weaken the immune system.I was hospitalized for COVID-19 within the last 90 days.I do not have any active infections like the flu or RSV.I am on dialysis or have severe kidney problems.I have severe or critical COVID-19.I have severe liver problems.You tested positive for COVID-19 within the last 5 days before joining the study.I am starting or planning to start remdesivir for my current COVID-19 infection.I have mild or moderate COVID-19, started showing symptoms within the last 5 days, and still have at least one symptom.
Research Study Groups:
This trial has the following groups:- Group 1: Bemnifosbuvir (BEM)
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Bemnifosbuvir (BEM) received clearance from the FDA?
"Bemnifosbuvir (BEM)'s safety is highly regarded with a score of 3, since it has gone through rigorous trials and been verified to have efficacy."
Answered by AI
What is the cumulative figure of individuals involved in this exploration?
"Indeed. According to clinicaltrials.gov, this research project is actively recruiting patients, with the original post appearing on November 25th 2022 and the most recent update occurring one day later. This experiment aims to admit 1500 people at a single location."
Answered by AI
Is there an open enrollment period for this clinical research?
"Affirmative. Clinicaltrials.gov lists this clinical trial as actively recruiting participants, with the first posting on November 25th 2022 and a recent update being made on the 26th of that same month. 1500 people must be recruited from one medical centre for completion."
Answered by AI
Who else is applying?
What site did they apply to?
Atea Study Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I'm more susceptible to getting sick after getting covid four times.
PatientReceived no prior treatments
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