1. Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19
- Author
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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, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Coombs, Robert, Degli-Angeli, Emily, Goecker, Erin, Daza, Glenda, Harb, Socorro, Dragavon, Joan, Aldrovandi, Grace, Murtaugh, William, Cooper, Marlene, Gutzman, Howard, Knowles, Kevin, Erhardt, Bill, Waring, Lorraine, Hessinger, Diane, Meintjes, Graeme A, Murray, Barbara E, Ray, Stuart Campbell, Rolla, Valeria Cavalcanti, Saloojee, Haroon, Tsiatis, Anastasios A, Volberding, Paul A, Kimmelman, Jonathan, Glidden, David, and Hunsberger, Sally
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Coronaviruses ,Clinical Research ,Infectious Diseases ,Emerging Infectious Diseases ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adult ,Humans ,COVID-19 ,SARS-CoV-2 ,Antiviral Agents ,RNA ,Viral ,Immunoglobulin G ,Double-Blind Method ,SAB-185 ,antibody ,polyclonal ,transchromosomic ,treatment ,ACTIV-2/A5401 Study Team ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Biological sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundSAB-185, a novel fully human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for nonhospitalized adults with mild-moderate coronavirus disease 2019 (COVID-19).MethodsParticipants 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.ResultsTwo-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.ConclusionsSAB-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.
- Published
- 2023