Oral bemnifosbuvir (AT-527) vs placebo in patients with mild-to-moderate COVID-19 in an outpatient setting (MORNINGSKY)

Horga A., Saenz R., YILMAZ G., Simón-Campos A., Pietropaolo K., Stubbings W. J., ...Daha Fazla

Future Virology, cilt.18, sa.13, ss.839-853, 2023 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 18 Sayı: 13
  • Basım Tarihi: 2023
  • Doi Numarası: 10.2217/fvl-2023-0115
  • Dergi Adı: Future Virology
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, CAB Abstracts, Chemical Abstracts Core, EMBASE
  • Sayfa Sayıları: ss.839-853
  • Anahtar Kelimeler: AT-527, bemnifosbuvir, COVID-19, oral, outpatient, SARS-CoV-2
  • Karadeniz Teknik Üniversitesi Adresli: Evet

Özet

Aim: This phase III study assessed the efficacy/safety/antiviral activity/pharmacokinetics of bemnifosbuvir, a novel, oral nucleotide analog to treat COVID-19. Patients & methods: Outpatient adults/adolescents with mild-to-moderate COVID-19 were randomized 2:1 to bemnifosbuvir/placebo. Time to symptom alleviation/improvement (primary outcome), risk of hospitalization/death, viral load and safety were evaluated. Results: Although the study was discontinued prematurely and did not meet its primary end point, bemnifosbuvir treatment resulted in fewer hospitalizations (71% relative risk reduction), COVID-19-related medically attended hospital visits, and COVID-19-related complications compared with placebo. No reduction in viral load was observed. The proportion of patients with adverse events was similar; no deaths occurred. Conclusion: Bemnifosbuvir showed hospitalization reduction in patients with variable disease progression risk and was well tolerated. Clinical Trial Registration: NCT04889040 (ClinicalTrials.gov). Tweetable abstract #Bemnifosbuvir is a novel, oral, nonmutagenic, nonteratogenic nucleotide analog with low potential for drug-drug interactions or resistance. Bemnifosbuvir showed a 71% reduction in hospitalization for #COVID-19 despite no symptom alleviation/viral load reduction differences. @ateapharm.