Compassionate Use of GC5131 (Hyperimmunoglobulin) Therapy in Critically Ill Patients Diagnosed with COVID-19: A Case Series and Review of Literature

Viruses. 2021 Sep 14;13(9):1826. doi: 10.3390/v13091826.

Abstract

Presently, the use of convalescent plasma and hyperimmunoglobulin obtained from individuals who have recovered from coronavirus disease 2019 (COVID-19) has proved to potentially provide passive antibody-based immunity, thereby leading to several clinical trials to develop an immune-based COVID-19 treatment. However, the therapeutic efficacy of hyperimmunoglobulin in critically ill patients with COVID-19 remains unknown. On 23 October 2020, we first administered GC5131 in a compassionate-use program to critically ill patients at the Kyungpook National University, Chilgok Hospital, Korea. Since then, five more critically ill patients were treated with GC5131 in this compassionate-use program in our hospital up until 17 December 2020. We retrospectively reviewed the clinical responses of six critically ill patients diagnosed with COVID-19 who received the hyperimmunoglobulin concentrate, GC5131, which was produced by the Green Cross Corporation. After the administration of GC5131, five patients died due to an exacerbation of COVID-19 pneumonia. GC5131 was ineffective when administered to critically ill patients with COVID-19. Nevertheless, we propose that to expect a therapeutic effect from GC5131, it should be administered as early as possible to avoid the excessive inflammatory response phase in patients with severe and advanced COVID-19 infection. This step was difficult to achieve in the real world due to the time required for decision making and the process of the compassionate-use program.

Keywords: COVID-19; clinical effectiveness; convalescence; immunoglobulin; plasma.

Publication types

  • Case Reports
  • Review

MeSH terms

  • Aged
  • COVID-19 / diagnosis
  • COVID-19 / therapy*
  • COVID-19 / virology*
  • COVID-19 Drug Treatment*
  • COVID-19 Serotherapy
  • Compassionate Use Trials
  • Critical Illness*
  • Female
  • Humans
  • Immunization, Passive
  • Immunoglobulins / therapeutic use*
  • Male
  • Republic of Korea
  • SARS-CoV-2 / drug effects*
  • Treatment Outcome

Substances

  • Immunoglobulins