Safety, Tolerability, and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) in Healthy Adults: a Randomized, Controlled, Double-Blinded, Phase 1 Study.

ABSTRACT: Anti-SARS-CoV-2 immunoglobulin (human) investigational product (COVID-HIGIV) is a purified immunoglobulin preparation containing SARS-CoV-2 polyclonal antibodies. This single-center clinical trial aimed to characterize the safety and pharmacokinetics of COVID-HIGIV in healthy, adult volunteers. Participants were enrolled to receive one of three doses of COVID-HIGIV (100, 200, 400 mg/kg) or placebo in a 2:2:2:1 randomization scheme. Between 24 December 2020 and 27 July 2021, 28 participants met eligibility and were randomized with 27 of these 28 (96.4%) being administered either COVID-HIGIV (n = 23) or placebo (n = 4). Only one SAE was observed, and it occurred in the placebo group. A total of 18 out of 27 participants (66.7%) reported 50 adverse events (AEs) overall. All COVI

SUBMITTER: Liu STH 

PROVIDER: S-EPMC10019156 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature