Study: Bemnifosbuvir for COVID-19

The Institute’s Global Clinical Trials Unit is enrolling participants in a trial of an investigational oral COVID-19 treatment called Bemnifosbuvir. While Paxlovid is currently available for treatment for COVID-19, drug interactions preclude its use in many patients.

This Phase III trial is a double blind, placebo-controlled multicenter study to assess the efficacy and safety of Bemnifosbuvir in high-risk outpatients with acute COVID-19. Bemnifosbuvir is an oral antiviral that does not have significant interactions with other medications.

The primary study objective is to evaluate the efficacy of Bemnifosbuvir compared with placebo in reducing all-cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care. Participants are permitted to be treated with other COVID-19 medications including Paxlovid.

To learn more or refer a patient, contact Miriam Chicurel-Bayard, RN, at 919-843-9922 or chicurel@med.unc.edu.

Patients may qualify for the trial if they:

• Have a positive SARS-CoV-2 diagnostic test conducted ≤ 5 days prior to randomization
• Mild or moderate COVID-19 with symptom onset ≤ 5 days prior to randomization and at least one COVID-19 related symptom present at time of screening
• Are at high risk for disease progression defined as:
  • Age ≥70 years

Or

• Age ≥55 years with one of the following risk factors:
  • 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 50 to 54 with two of the following risk factors:
• 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 home care residents
    • Or one of the following immunocompromising conditions or immunosuppressive treatments:
      • On immunosuppressive regimens including chemotherapy for the treatment of cancer
      • Hematologic malignancy associated with poor response to COVID-19 vaccines (eg, CLL, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
      • Being within 2 years of 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 (mm³)
      • Moderate or severe primary immunodeficiency disorder
      • Active treatment with an immunosuppressive medication regimen (e.g., high-dose corticosteroids [ie, 20 mg of prednisone daily or equivalent for ≥2 weeks], alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents that are severely immunosuppressive, tumor necrosis factor [TNF] blockers, biologics that are immunosuppressive)

All enrolled participants will be randomized 1:1 to receive either a 5-day course of Bemnifosbuvir or placebo in addition to standard treatment.

Learn more:

Please contact Miriam Chicurel-Bayard, RN, at 919-843-9922 or chicurel@med.unc.edu to learn more or refer a patient.