COVID-19 SARS-CoV-2
Conditions
Interventions
Eligible subjects will be randomized 1:1 (active:placebo) to one of the
following arms:
• 550 mg BEM (2 x 275 mg tablets) BID
• Placebo (2 tablets) BID
BEM 550 mg or matching placebo will be adminis
Sponsors
Atea Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide informed consent. 2. Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) conducted = 20 breaths per minute, heart rate >= 90 beats per minute; with saturation of oxygen (SpO2) > 93% on room air at sea level - No clinical signs indicative of severe or critical illness severity 4. For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of study drug. 5. Females of childbearing potential must have a negative pregnancy test prior to initiation of study drug. 6. Subject must be able to take oral tablet medications. 7. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements. 8. Subject must be high risk, defined below. • Age >=80 years OR • Age >=65 years with one of the following: - Obesity (body mass index [BMI] >=30 kg/m2) - Diabetes mellitus - Cardiovascular disease (including congenital heart disease) or hypertension (with at least one medication recommended or prescribed) - Chronic lung disease requiring routine therapy (e.g., chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) OR • Age >=18 years with one of the following: - Down syndrome, sickle cell disease, dementia, Parkinson*s disease, or care home residents - One of the following immunocompromising conditions or immunosuppressive treatment: o Receiving chemotherapy or other therapies for cancer o Hematologic malignancy (active or in remission) o Being within 2 years from receiving a hematopoietic stem cell or at any time following a solid organ transplant o Human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter (mm3) within the past 6 months o Combined primary immunodeficiency disorder o Taking immunosuppressive medications (e.g., drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions such as anti-tumor necrosis factor (TNF) agents, mycophenolate, or rituximab)
Exclusion criteria
Exclusion criteria: 1. Female subject is pregnant or breastfeeding. 2. Clinical signs or symptoms indicative of severe or critical COVID-19 illness, including any of the following: shortness of breath at rest, respiratory rate >=*30 breaths per minute, heart rate >= 125 beats per minute, SpO2 = 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, mAbs) will be permitted, as long as there are no concerns for DDIs (e.g., remdesivir would not be permitted). 8. Other known active viral or bacterial infection at the time of screening, such as influenza (i.e., as verified by a locally available rapid flu test at screening_ and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met. 9. Receiving dialysis or have known moderate to severe renal impairment [i.e. estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula]. Note: If the investigator suspects the subject may have eGFR <45 mL/min/1.73 m2, a confirmatory test should be performed at screening to confirm eligibility before the first dose of st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the proportion of subjects in the supportive-care-only population who are hospitalized for any cause or died due to any cause through Day 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of subjects in the supportive-care-only population with COVID-19-related hospitalization or who died due to any cause through Day 29 • Proportion of subjects in the overall study population, the supportive care-only population, and the combination antiviral population who died due to any cause through Day 29 and Day 60 • Proportion of subjects in the supportive-care-only population with COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure) • Proportion of subjects in the supportive-care-only population with COVID-19-related 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 through Day 29 and Day 60 • Proportion of subjects with COVID-19 symptom relapse in each population through Day 29 • Proportion of subjects in each population with viral load rebound through Day 29 | — |
Countries
Netherlands
Outcome results
None listed