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Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19.
Taiwo, Babafemi O; Chew, Kara W; Moser, Carlee; Wohl, David Alain; Daar, Eric S; Li, Jonathan Z; Greninger, Alexander L; Bausch, Christoph; Luke, Thomas; Hoover, Keila; Neytman, Gene; Giganti, Mark J; Olefsky, Maxine; Javan, Arzhang Cyrus; Fletcher, Courtney V; Eron, Joseph J; Currier, Judith S; Hughes, Michael D; Smith, Davey M.
Afiliación
  • Taiwo BO; Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
  • Chew KW; Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
  • Moser C; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Wohl DA; Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
  • Daar ES; Lundquist Institute, Harbor-University of California Los Angeles Medical Center, Torrance, California, USA.
  • Li JZ; Department of Medicine, Harvard Medical School, Cambridge, Massachusetts, USA.
  • Greninger AL; Department of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle, Washington, USA.
  • Bausch C; SAB Biotherapeutics, Inc, Sioux Falls, South Dakota, USA.
  • Luke T; Miami Clinical Research, Miami, Florida, USA.
  • Hoover K; Miami Clinical Research, Miami, Florida, USA.
  • Neytman G; Quantum Clinical Trials, Miami, Florida, USA.
  • Giganti MJ; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Olefsky M; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Javan AC; Division of Acquired Immune Deficiency Syndrome, National Institutes of Health, Bethesda, Maryland, USA.
  • Fletcher CV; Center for Drug Discovery, University of Nebraska Medical Center, Omaha, Nebraska, USA.
  • Eron JJ; Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
  • Currier JS; Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
  • Hughes MD; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Smith DM; Department of Medicine, University of California San Diego, La Jolla, California, USA.
J Infect Dis ; 228(2): 133-142, 2023 07 14.
Article en En | MEDLINE | ID: mdl-36661240
BACKGROUND: SAB-185, a novel fully human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for nonhospitalized adults with mild-moderate coronavirus disease 2019 (COVID-19). METHODS: Participants received intravenous SAB-185 3840 units/kg (low-dose) or placebo, or 10 240 units/kg (high-dose) or placebo. Primary outcome measures were nasopharyngeal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA < lower limit of quantification (LLOQ) at study days 3, 7, and 14, time to symptomatic improvement, and safety through day 28. RESULTS: Two-hundred thirteen participants received low-dose SAB-185/placebo (n = 107/106) and 215 high-dose SAB-185/placebo (n = 110/105). The proportions with SARS-CoV-2 RNA < LLOQ were higher for SAB-185 versus placebo at days 3 and 7 and similar at day 14, and significantly higher at day 7 for high-dose SAB-185 versus placebo only, relative risk 1.23 (95% confidence interval, 1.01-1.49). At day 3, SARS-CoV-2 RNA levels were lower with low-dose and high-dose SAB-185 versus placebo: differences in medians of -0.78 log10 copies/mL (P = .08) and -0.71 log10 copies/mL (P = .10), respectively. No difference was observed in time to symptom improvement: median 11/10 days (P = .24) for low-dose SAB-185/placebo and 8/10 days (P = .50) for high-dose SAB-185/placebo. Grade ≥3 adverse events occurred in 5%/13% of low-dose SAB-185/placebo and 9%/12% of high-dose SAB-185/placebo. CONCLUSIONS: SAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk nonhospitalized adults with COVID-19. Clinical Trials Registration. NCT04518410.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adult / Humans Idioma: En Revista: J Infect Dis Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adult / Humans Idioma: En Revista: J Infect Dis Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos