학술논문
Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19
Document Type
article
Author
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; Hunsberger, Sally
Source
The Journal of Infectious Diseases. 228(2)
Subject
Language
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.