Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

JRCT ID: jRCT2071240070

Registered date:16/10/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: SARS CoV 2 Infection/COVID-19
• Date of first enrollment: 25/11/2022
• Target sample size: 2510
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Canada,Japan,Germany,Japan,India,Japan,Latvia,Japan,Mexico,Japan,Netherlands,Japan,Pakistan,Japan,Philippines,Japan,Romania,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Tunisia,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

- Drug: Bemnifosbuvir (BEM)
- BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
- Other Names:
- AT-527
- Drug: Placebo
- Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days

Outcome(s)

• Primary Outcome: Proportion of subjects hospitalized for any cause or died due to any cause [Time Frame: Day 1 through Day 29]

Secondary Outcome

1. Proportion of subjects hospitalized due to COVID-19 or died due to any cause [Time Frame: Day 1 through Day 29]
2. Proportion of subjects who died due to any cause [Time Frame: Day 1 through Day 29; Day 1 through Day 60]
3. Proportion of subjects with COVID-19-related complications [Time Frame: Day 1 through Day 29]
4. 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 [Time Frame: Day 1 through Day 29; Day 1 through Day 60]
5. Proportion of subjects with COVID-19 symptom relapse [Time Frame: Day 1 through Day 29]
6. Proportion of subjects with viral load rebound [Time Frame: Day 1 through Day 29]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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:
1. Age 70 yea>=rs OR
2. 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
3. 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
4. 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
- Use of adequate contraception for females of childbearing potential

Exclude 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 nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted.
- 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 severe renal impairment
- History of severe hepatic impairment (Child-Pugh Class C)
- Known allergy or hypersensitivity to components of study drug

Related Information

• Primary Sponsor: Hamada Ryusuke
• Secondary ID(s): NCT05629962