Evidence map›Paper›PMID 37811130›Full record

ArticleCritical care explorations2023

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

Claudio M Martin, Marat Slessarev, Eileen Campbell, John Basmaji, Ian Ball, Douglas D Fraser, Aleksandra Leligdowicz, Tina Mele, Fran Priestap, Brent J Tschirhart and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Critical care explorations, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 5 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Claudio M MartinDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Marat SlessarevDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Eileen CampbellLawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
John BasmajiDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Ian BallDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Douglas D FraserLawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
Aleksandra LeligdowiczDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Tina MeleDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Fran PriestapDivision of Critical Care Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Brent J TschirhartLawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
Tracey BentallLawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
Xiangru LuDepartment of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Qingping FengLawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
London Health Sciences Centre · CALawson Health Research Institute · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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).

designDouble-blind, randomized clinical trial.

settingTwo 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.

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

resultsWe 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.

conclusionsAlthough 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.

Indexed as

annexin A5feasibilitysafetysepsissevere coronavirus disease 2019SY-005

Identifiers

PMID37811130
PMCPMC10558223
OpenAlexW4387378679

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.