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,

SUBMITTER: Martin CM 

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

REPOSITORIES: biostudies-literature