Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19.

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, ACTIV-2/A5401 Study Team
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 228 Issue 2 Pg. 133-142 (Jul 14 2023) ISSN: 1537-6613 [Electronic] United States
• PMID: 36661240 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• SAB-185
• Antiviral Agents
• RNA, Viral
• Immunoglobulin G

Topics

• Adult
• Humans
• COVID-19
• SARS-CoV-2
• Antiviral Agents (adverse effects)
• RNA, Viral
• Immunoglobulin G
• Double-Blind Method