Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19
© 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: journals.permissionsoup.com..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:228 |
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| Enthalten in: |
The Journal of infectious diseases - 228(2023), 2 vom: 14. Juli, Seite 133-142 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Taiwo, Babafemi O [VerfasserIn] |
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| Links: |
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| Themen: |
Antibody |
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| Anmerkungen: |
Date Completed 17.07.2023 Date Revised 06.02.2024 published: Print ClinicalTrials.gov: NCT04518410 Citation Status MEDLINE |
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| doi: |
10.1093/infdis/jiad013 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Taiwo, Babafemi O |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19 |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 17.07.2023 | ||
| 500 | |a Date Revised 06.02.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT04518410 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 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: journals.permissionsoup.com. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SAB-185 | |
| 650 | 4 | |a antibody | |
| 650 | 4 | |a polyclonal | |
| 650 | 4 | |a transchromosomic | |
| 650 | 4 | |a treatment | |
| 650 | 7 | |a SAB-185 |2 NLM | |
| 650 | 7 | |a GZH7FFK82R |2 NLM | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 700 | 1 | |a Chew, Kara W |e verfasserin |4 aut | |
| 700 | 1 | |a Moser, Carlee |e verfasserin |4 aut | |
| 700 | 1 | |a Wohl, David Alain |e verfasserin |4 aut | |
| 700 | 1 | |a Daar, Eric S |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jonathan Z |e verfasserin |4 aut | |
| 700 | 1 | |a Greninger, Alexander L |e verfasserin |4 aut | |
| 700 | 1 | |a Bausch, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Luke, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Hoover, Keila |e verfasserin |4 aut | |
| 700 | 1 | |a Neytman, Gene |e verfasserin |4 aut | |
| 700 | 1 | |a Giganti, Mark J |e verfasserin |4 aut | |
| 700 | 1 | |a Olefsky, Maxine |e verfasserin |4 aut | |
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| 700 | 1 | |a Fletcher, Courtney V |e verfasserin |4 aut | |
| 700 | 1 | |a Eron, Joseph J |e verfasserin |4 aut | |
| 700 | 1 | |a Currier, Judith S |e verfasserin |4 aut | |
| 700 | 1 | |a Hughes, Michael D |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Davey M |e verfasserin |4 aut | |
| 700 | 0 | |a ACTIV-2/A5401 Study Team |e verfasserin |4 aut | |
| 700 | 1 | |a Hosey, Lara |e investigator |4 oth | |
| 700 | 1 | |a Roa, Jhoanna |e investigator |4 oth | |
| 700 | 1 | |a Patel, Nilam |e investigator |4 oth | |
| 700 | 1 | |a Coombs, Robert |e investigator |4 oth | |
| 700 | 1 | |a Degli-Angeli, Emily |e investigator |4 oth | |
| 700 | 1 | |a Goecker, Erin |e investigator |4 oth | |
| 700 | 1 | |a Daza, Glenda |e investigator |4 oth | |
| 700 | 1 | |a Harb, Socorro |e investigator |4 oth | |
| 700 | 1 | |a Dragavon, Joan |e investigator |4 oth | |
| 700 | 1 | |a Aldrovandi, Grace |e investigator |4 oth | |
| 700 | 1 | |a Murtaugh, William |e investigator |4 oth | |
| 700 | 1 | |a Cooper, Marlene |e investigator |4 oth | |
| 700 | 1 | |a Gutzman, Howard |e investigator |4 oth | |
| 700 | 1 | |a Knowles, Kevin |e investigator |4 oth | |
| 700 | 1 | |a Erhardt, Bill |e investigator |4 oth | |
| 700 | 1 | |a Waring, Lorraine |e investigator |4 oth | |
| 700 | 1 | |a Hessinger, Diane |e investigator |4 oth | |
| 700 | 1 | |a Meintjes, Graeme A |e investigator |4 oth | |
| 700 | 1 | |a Murray, Barbara E |e investigator |4 oth | |
| 700 | 1 | |a Ray, Stuart Campbell |e investigator |4 oth | |
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| 700 | 1 | |a Saloojee, Haroon |e investigator |4 oth | |
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| 700 | 1 | |a Hunsberger, Sally |e investigator |4 oth | |
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