Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.

ABSTRACT:

Background

We evaluated the fully human polyclonal antibody product SAB-185 in a phase 3 trial for COVID-19.

Methods

Nonhospitalized 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.

Results

Enrollment ended early due to low hospitalization/death rates upon O

SUBMITTER: Chew KW 

PROVIDER: S-EPMC11566225 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature