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- Title
Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19.
- Authors
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; Team, for the ACTIV-2/A5401 Study
- 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.
- Subjects
SARS-CoV-2; CORONAVIRUS diseases; COVID-19; CLINICAL trial registries; IMMUNOGLOBULIN G
- Publication
Journal of Infectious Diseases, 2023, Vol 228, Issue 2, p133
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiad013