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Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review

The purpose of this systematic review was to describe the characteristics of clinical trials that focused on COVID-19 patients with cytokine release syndrome (CRS) and the variability in CRS definitions. Two authors independently searched three clinical trial registries and included interventional c...

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Autores principales: Eljaaly, Khalid, Malibary, Husam, Alsulami, Shaimaa, Albanji, Muradi, Badawi, Mazen, Al-Tawfiq, Jaffar A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8229812/
https://www.ncbi.nlm.nih.gov/pubmed/34199506
http://dx.doi.org/10.3390/pathogens10060692
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author Eljaaly, Khalid
Malibary, Husam
Alsulami, Shaimaa
Albanji, Muradi
Badawi, Mazen
Al-Tawfiq, Jaffar A.
author_facet Eljaaly, Khalid
Malibary, Husam
Alsulami, Shaimaa
Albanji, Muradi
Badawi, Mazen
Al-Tawfiq, Jaffar A.
author_sort Eljaaly, Khalid
collection PubMed
description The purpose of this systematic review was to describe the characteristics of clinical trials that focused on COVID-19 patients with cytokine release syndrome (CRS) and the variability in CRS definitions. Two authors independently searched three clinical trial registries and included interventional clinical trials on COVID-19 hospitalized patients that required at least one elevated inflammatory biomarker. Relevant data, including the type and cutoff of the measured biomarker, oxygen/respiratory criteria, fever, radiologic criteria, and medications, were summarized. A total of 47 clinical trials were included. The included studies considered the following criteria: oxygen/respiratory criteria in 42 trials (89%), radiologic criteria in 29 trials (62%), and fever in 6 trials (18%). Serum ferritin was measured in 35 trials (74%), CRP in 34 trials (72%), D-dimer in 26 trials (55%), LDH in 24 trials (51%), lymphocyte count in 14 trials (30%), and IL-6 in 8 trials (17%). The cutoff values were variable for the included biomarkers. The most commonly used medications were tocilizumab, in 15 trials (32%), and anakinra in 10 trials (24.4%). This systematic review found high variability in CRS definitions and associated biomarker cutoff values in COVID-19 clinical trials. We call for a standardized definition of CRS, especially in COVID-19 patients.
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spelling pubmed-82298122021-06-26 Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review Eljaaly, Khalid Malibary, Husam Alsulami, Shaimaa Albanji, Muradi Badawi, Mazen Al-Tawfiq, Jaffar A. Pathogens Systematic Review The purpose of this systematic review was to describe the characteristics of clinical trials that focused on COVID-19 patients with cytokine release syndrome (CRS) and the variability in CRS definitions. Two authors independently searched three clinical trial registries and included interventional clinical trials on COVID-19 hospitalized patients that required at least one elevated inflammatory biomarker. Relevant data, including the type and cutoff of the measured biomarker, oxygen/respiratory criteria, fever, radiologic criteria, and medications, were summarized. A total of 47 clinical trials were included. The included studies considered the following criteria: oxygen/respiratory criteria in 42 trials (89%), radiologic criteria in 29 trials (62%), and fever in 6 trials (18%). Serum ferritin was measured in 35 trials (74%), CRP in 34 trials (72%), D-dimer in 26 trials (55%), LDH in 24 trials (51%), lymphocyte count in 14 trials (30%), and IL-6 in 8 trials (17%). The cutoff values were variable for the included biomarkers. The most commonly used medications were tocilizumab, in 15 trials (32%), and anakinra in 10 trials (24.4%). This systematic review found high variability in CRS definitions and associated biomarker cutoff values in COVID-19 clinical trials. We call for a standardized definition of CRS, especially in COVID-19 patients. MDPI 2021-06-02 /pmc/articles/PMC8229812/ /pubmed/34199506 http://dx.doi.org/10.3390/pathogens10060692 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Systematic Review
Eljaaly, Khalid
Malibary, Husam
Alsulami, Shaimaa
Albanji, Muradi
Badawi, Mazen
Al-Tawfiq, Jaffar A.
Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title_full Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title_fullStr Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title_full_unstemmed Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title_short Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review
title_sort description and analysis of cytokine storm in registered covid-19 clinical trials: a systematic review
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8229812/
https://www.ncbi.nlm.nih.gov/pubmed/34199506
http://dx.doi.org/10.3390/pathogens10060692
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