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


ABSTRACT:

Objectives

To evaluate the study design and feasibility of drug administration and safety in a randomized clinical trial of recombinant human annexin A5 (SY-005), a constitutively expressed protein with anti-inflammatory, antiapoptotic, and anticoagulant properties, in patients with severe coronavirus disease 2019 (COVID-19).

Design

Double-blind, randomized clinical trial.

Setting

Two ICUs at an academic medical center.

Patients/subjects

Adults admitted to the ICU with a confirmed diagnosis of COVID-19 and requiring ventilatory or vasopressor support.

Interventions

SY-005, a recombinant human annexin A5, at 50 or 100 µg/kg IV every 12 hours for 7 days.

Measurements and main results

We enrolled 18 of the 55 eligible patients (33%) between April 21, 2021, and February 3, 2022. We administered 82% (196/238) of the anticipated doses of study medication and 86% (169/196) were given within 1 hour of the scheduled time. There were no drug-related serious adverse events. We captured 100% of the data that would be required for measuring clinical outcomes in a phase 2 or 3 trial.

Limitations

The small sample size was a result of decreasing admissions of patients with COVID-19, which triggered a stopping rule for the trial.

Conclusions

Although enrollment was low, administration of SY-005 to critically ill patients with COVID-19 every 12 hours for up to 7 days was feasible and safe. Further clinical trials of annexin A5 for the treatment of COVID-19 are warranted. Given reduction of severe COVID-19 disease, future studies should explore the safety and effectiveness of SY-005 use in non-COVID-related sepsis.

SUBMITTER: Martin CM 

PROVIDER: S-EPMC10558223 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Martin Claudio M CM   Slessarev Marat M   Campbell Eileen E   Basmaji John J   Ball Ian I   Fraser Douglas D DD   Leligdowicz Aleksandra A   Mele Tina T   Priestap Fran F   Tschirhart Brent J BJ   Bentall Tracey T   Lu Xiangru X   Feng Qingping Q  

Critical care explorations 20231005 10


<h4>Objectives</h4>To evaluate the study design and feasibility of drug administration and safety in a randomized clinical trial of recombinant human annexin A5 (SY-005), a constitutively expressed protein with anti-inflammatory, antiapoptotic, and anticoagulant properties, in patients with severe coronavirus disease 2019 (COVID-19).<h4>Design</h4>Double-blind, randomized clinical trial.<h4>Setting</h4>Two ICUs at an academic medical center.<h4>Patients/subjects</h4>Adults admitted to the ICU wi  ...[more]

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