Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)

Summary

The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.

Timeline

Start

2020-05-28

Primary completion

2021-09-01

Completion

2021-12-13

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper efficacy could not be evaluated in this study. PMID 36965173 ↗

Publications

• Jacquot C, Gordon O, Noland D, Donowitz JR, Levy E, Jain S, Willis Z, Rimland C, Loi M, Arrieta A, Annen K, Drapeau N, Osborne S, Ardura MI, Arora S, Zivick E, Delaney M. Multi-institutional experience with COVID-19 convalescent plasma in children. Transfusion. 2023 May;63(5):918-924. doi: 10.1111/trf.17318. Epub 2023 Mar 30.
• Gordon O, Brosnan MK, Yoon S, Jung D, Littlefield K, Ganesan A, Caputo CA, Li M, Morgenlander WR, Henson SN, Ordonez AA, De Jesus P, Tucker EW, Peart Akindele N, Ma Z, Wilson J, Ruiz-Bedoya CA, Younger MEM, Bloch EM, Shoham S, Sullivan D, Tobian AA, Cooke KR, Larman B, Gobburu JV, Casadevall A, Pekosz A, Lederman HM, Klein SL, Jain SK. Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children. JCI Insight. 2022 Jan 25;7(2):e151518. doi: 10.1172/jci.insight.151518.

Drugs

Indications