| Autor: |
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 |
| Předmět: |
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| Zdroj: |
Journal of Infectious Diseases; 7/15/2023, Vol. 228 Issue 2, p133-142, 10p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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