ABSTRACT
C.H.
The authors declare a conflict of interest. Emergent is receiving funding from the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Health Agency, under Other Transaction number W911QY-20-9-0013, for the development of COVID-HIGIV, a countermeasure to SARS-CoV-2. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government. J.A.A. serves on advisory boards for GSK/ViiV and Merck. J.A.A. is on a data safety monitoring board for Kintor Pharmaceuticals. D.M.A., C.H., G.L., and M.M. were employees of Emergent BioSolutions during the conduct of this study. D.M.A., C.H., and M.M. own shares of Emergent BioSolutions. C.H. holds a pending patent: '63/403,074 Hyperimmune Globulins for Treatment and Prevention of COVID-19'. S.T.H.L. has received consulting fees from Synairgen.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 (