Trial reportThe Journal of infectious diseases2024
Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.
Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04518410 (Adaptive Platform Treatment Trial for Outpatients With COVID-19), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Who cites it
2 citing papers in PubMed.
- Article
- Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial.Contemporary clinical trials · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
backgroundWe evaluated the fully human polyclonal antibody product SAB-185 in a phase 3 trial for COVID-19.
methodsNonhospitalized high-risk adults within 7 days of symptom onset were randomized 1:1 to open-label SAB-185 3840 units/kg or casirivimab/imdevimab 1200 mg. Noninferiority comparison was undertaken for pre-Omicron population (casirivimab/imdevimab expected to be fully active) and superiority comparison for the Omicron population (casirivimab/imdevimab not expected to be active). Primary outcomes were the composite of all-cause hospitalizations/deaths and grade ≥3 treatment-emergent adverse events (TEAEs) through day 28. A secondary outcome was time to sustained symptom resolution.
resultsEnrollment ended early due to low hospitalization/death rates upon Omicron emergence; 255 adults were in pre-Omicron and 392 in Omicron populations. Hospitalizations/deaths occurred in 6 (5.0%) and 3 (2.2%) of pre-Omicron SAB-185 and casirivimab/imdevimab arms (absolute difference 2.7%; 95% confidence interval [CI], -2.3%-8.6%); and 5 (2.5%) versus 3 (1.5%) (absolute difference 1.0%; 95% CI, -2.3%-4.5%) for Omicron. All risk ratios for grade ≥3 TEAEs were not significant. Time to symptom resolution was significantly shorter for SAB-185 for Omicron only: 18 versus >25 days; P =.006.
conclusionsSAB-185 had an acceptable safety profile with faster symptom resolution in the Omicron population. CLINICAL TRIALS REGISTRATION: NCT04518410.
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