Phase 2 safety and antiviral activity of SAB-185, a novel polyclonal antibody therapy for non-hospitalized adults with COVID-19

Public Deposited
Analytics

Downloadable Content

Download PDF
Request Version for Screen Reader
Creator
  • Taiwo, Babafemi O
    • Other Affiliation: Northwestern University
  • Chew, Kara W
    • Other Affiliation: University of California, Los Angeles
  • Moser, Carlee
    • Other Affiliation: Harvard T.H. Chan School of Public Health
  • Wohl, David Alain
    • Affiliation: School of Medicine, Department of Medicine
  • Daar, Eric S
    • Other Affiliation: Harbor-UCLA Medical Center
  • Li, Jonathan Z
    • Other Affiliation: Harvard Medical School
  • Greninger, Alexander L
    • Other Affiliation: University of Washington Medical Center
  • Bausch, Christoph
    • Other Affiliation: SAB Biotherapeutics, Inc.
  • Luke, Thomas
    • Other Affiliation: SAB Biotherapeutics, Inc.
  • Hoover, Keila
    • Other Affiliation: Miami Clinical Research
  • Neytman, Gene
    • Other Affiliation: Quantum Clinical Trials
  • Giganti, Mark J
    • Other Affiliation: Harvard T.H. Chan School of Public Health
  • Olefsky, Maxine
    • Other Affiliation: Harvard T.H. Chan School of Public Health
  • Javan, Arzhang Cyrus
    • Other Affiliation: National Institutes of Health
  • Fletcher, Courtney V
    • Other Affiliation: University of Nebraska Medical Center
  • Eron, Joseph J
    • Affiliation: School of Medicine, Department of Medicine
  • Currier, Judith S
    • Other Affiliation: University of California, Los Angeles
  • Hughes, Michael D
    • Other Affiliation: Harvard T.H. Chan School of Public Health
  • Smith, Davey M
    • Other Affiliation: University of California, San Diego
  • ACTIV-2/A5401 Study Team
Abstract
  • SAB-185, a novel fully-human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for non-hospitalized adults with mild-moderate COVID-19.Participants received intravenous SAB-185 3,840 units/kg (low-dose) or placebo, or 10,240 units/kg (high-dose) or placebo. Primary outcome measures were nasopharyngeal 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.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 versus placebo only, relative risk (95% CI) 1.23 (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 log10copies/mL (p=0.08) and -0.71 log10copies/mL (p=0.10), respectively. No difference was observed in time to symptom improvement: median 11/10 days (p=0.24) for low-dose SAB-185/placebo and 8/10 days (p=0.50) 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.SAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk non-hospitalized adults with COVID-19.
Date of publication
DOI
Identifier
Resource type
  • Article
Journal title
  • The Journal of Infectious Diseases
Page start
  • jiad013
Language
  • English
Version
  • Postprint
ISSN
  • 0022-1899
Publisher
  • Oxford University Press

Relations

Parents:

This work has no parents.

In Collection:

Items

Thumbnail Title Date Uploaded Visibility Actions
file details jiad013.pdf 2023-02-02 Public Download