- 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
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.