Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19
Year: 2023
Type: article
Abstract: 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.
Authors: Babafemi O Taiwo, Kara W Chew, Carlee Moser, David Alain Wohl, Eric S Daar, Jonathan Z Li, Alexander L Greninger, Christoph Bausch, Thomas Luke, Keila Hoover, Gene Neytman, Mark J Giganti, Maxine Olefsky, Arzhang Cyrus Javan, Courtney V Fletcher, Joseph J Eron, Judith S Currier, Michael D Hughes, Davey M Smith, for the ACTIV-2/A5401 Study Team, Lara Hosey, Jhoanna Roa, Nilam Patel, Robert Coombs, Emily Degli-Angeli, Erin Goecker, Glenda Daza, Socorro Harb, Joan Dragavon, Grace Aldrovandi, William Murtaugh, Marlene Cooper, Howard Gutzman, Kevin Knowles, Bill Erhardt, Lorraine Waring, Diane Hessinger, Graeme A Meintjes, Barbara E Murray, Stuart Campbell Ray, Valeria Cavalcanti Rolla, Haroon Saloojee, Anastasios A Tsiatis, Paul A Volberding, Jonathan Kimmelman, David Glidden, Sally Hunsberger
Institutions: Northwestern University, University of California, Los Angeles, Harvard University, University of North Carolina at Chapel Hill, The Lundquist Institute, Los Angeles Medical Center, Harbor–UCLA Medical Center, University of Washington, University of Washington Medical Center, Sab Biotherapeutics (United States), Anaheim Clinical Trials, National Institutes of Health, University of Nebraska Medical Center, University of California San Diego
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1050281965, G1386795942, G2501702145, G2737559749, UCLA Clinical and Translational Science Institute, G343705321, G4553935269, G650174051, G681742546, G857487509, G9000047228, G9000182931, AIDS Clinical Trial Group Laboratory Center, UCLA Clinical and Translational Science Institute, G961682679
OpenAlex ID: W4317568271