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Annexin A5 in Patients With Severe COVID-19 Disease: A Single-Center, Randomized, Double-Blind, Placebo-Controlled

Claudio M Martin1,2, Marat Slessarev1,2, Eileen Campbell2

  • 1Division of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

Critical Care Explorations
|October 9, 2023
PubMed
Abstract

Insights

Recombinant human annexin A5 (SY-005) administration was feasible and safe in critically ill COVID-19 patients. Further trials are warranted for annexin A5 in COVID-19 and sepsis.

Area of Science:

  • Critical care medicine
  • Pharmacology
  • Immunology

Background:

  • Severe coronavirus disease 2019 (COVID-19) presents significant challenges in critical care.
  • Recombinant human annexin A5 (SY-005) exhibits anti-inflammatory, antiapoptotic, and anticoagulant properties.
  • Investigating novel therapeutic agents for severe COVID-19 is crucial.

Purpose of the Study:

  • To assess the study design and feasibility of administering recombinant human annexin A5 (SY-005).
  • To evaluate the safety of SY-005 in patients with severe COVID-19.
  • To determine the drug administration and safety profile in a randomized clinical trial setting.

Main Methods:

  • A double-blind, randomized clinical trial was conducted in two intensive care units (ICUs).
  • Adult patients with confirmed COVID-19 requiring ventilatory or vasopressor support were enrolled.
  • SY-005 was administered intravenously at 50 or 100 µg/kg every 12 hours for 7 days.

Main Results:

  • Enrollment included 18 of 55 eligible patients (33%) due to decreasing COVID-19 admissions.
  • 82% of planned SY-005 doses were administered, with 86% given within the scheduled hour.
  • No drug-related serious adverse events were reported, and 100% of outcome data were captured.

Conclusions:

  • Despite low enrollment, SY-005 administration every 12 hours for up to 7 days was feasible and safe in critically ill COVID-19 patients.
  • Further clinical trials of annexin A5 for COVID-19 treatment are recommended.
  • Future studies should explore SY-005 safety and effectiveness in non-COVID-19 sepsis.
Keywords:
SY-005annexin A5feasibilitysafetysepsissevere coronavirus disease 2019

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