SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bemnifosbuvir (BEM)
|
Drug: Bemnifosbuvir (BEM)
BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects hospitalized for any cause or died due to any cause [Day 1 through Day 29]
Secondary Outcome Measures
- Proportion of subjects hospitalized due to COVID-19 or died due to any cause [Day 1 through Day 29]
- Proportion of subjects who died due to any cause [Day 1 through Day 29; Day 1 through Day 60]
- Proportion of subjects with COVID-19-related complications [Day 1 through Day 29]
- Proportion of subjects with COVID-19-medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit) or who died due to any cause [Day 1 through Day 29; Day 1 through Day 60]
- Proportion of subjects with COVID-19 symptom relapse [Day 1 through Day 29]
- Proportion of subjects with viral load rebound [Day 1 through Day 29]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Positive SARS-CoV-2 test conducted ≤ 5 days prior to randomization
-
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
-
Subject must be high risk, defined below:
-
Age ≥80 years OR
-
Age ≥65 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 ≥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 treatment: receiving chemotherapy or other therapies for cancer, hematologic malignancy, being within 2 years from receiving a hematopoietic stem cell or at any time following a solid organ transplant, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter within the past 6 months, combined primary immunodeficiency disorder, taking immunosuppressive medications
- Use of adequate contraception for females of childbearing potential
Exclusion Criteria:
-
Severe or critical COVID-19 illness
-
Admitted to a hospital within 90 days prior to randomization due to COVID-19
-
Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study
-
Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection
-
Requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to Paxlovid, molnupiravir, favipiravir, monoclonal antibodies) will be permitted, as long as there are no concerns for drug interactions.
-
Other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis C virus (HCV) or HIV providing other eligibility criteria are met.
-
Receiving dialysis or have known moderate to severe renal impairment
-
History of severe hepatic impairment (Child-Pugh Class C)
-
Known allergy or hypersensitivity to components of study drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atea Study Site | Los Angeles | California | United States | 90017 |
Sponsors and Collaborators
- Atea Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AT-03A-017