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Antiviral

Bemnifosbuvir for COVID-19

Phase 3
Recruiting
Research Sponsored by Atea Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥70 years OR Age ≥55 years with one of the following: i) obesity (body mass index [BMI] ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR Age 50 to 54 years with two of the following: i) obesity (BMI ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR Age ≥18 years with one of the following: i) Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents ii) One of the following immunocompromising conditions or immunosuppressive treatments: receiving chemotherapy for cancer, hematologic malignancy, being within 2 years of a hematopoietic stem cell transplant, receipt of a solid organ transplant and on immunosuppressive therapy, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter, moderate/severe primary immunodeficiency, taking immunosuppressive medications
Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
I have mild or moderate COVID-19, started showing symptoms within the last 5 days, and still have at least one symptom.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 29; day 1 through day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 29; day 1 through day 60 for reporting.

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 more

Trial 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
26 Previous Clinical Trials
1,494 Total Patients Enrolled
4 Trials studying COVID-19
475 Patients Enrolled for COVID-19

Media Library

Bemnifosbuvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05629962 — Phase 3
COVID-19 Research Study Groups: Bemnifosbuvir (BEM), Placebo
COVID-19 Clinical Trial 2023: Bemnifosbuvir Highlights & Side Effects. Trial Name: NCT05629962 — Phase 3
Bemnifosbuvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629962 — Phase 3

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
~1076 spots leftby Mar 2025