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The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review
Background: Standard of Care (SoC) has been used with different significance across Randomized Clinical Trials (RCTs) on the treatment of Covid-19. In the context of a living systematic review on pharmacological interventions for COVID-19, we assessed the characteristics of the SoC adopted in the pu...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558371/ https://www.ncbi.nlm.nih.gov/pubmed/34733161 http://dx.doi.org/10.3389/fphar.2021.749514 |
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author | Addis, Antonio Amato, Laura Cruciani, Fabio Saulle, Rosella De Crescenzo, Franco Mitrova, Zuzana Vecchi, Simona Perrone, Francesco Davoli, Marina |
author_facet | Addis, Antonio Amato, Laura Cruciani, Fabio Saulle, Rosella De Crescenzo, Franco Mitrova, Zuzana Vecchi, Simona Perrone, Francesco Davoli, Marina |
author_sort | Addis, Antonio |
collection | PubMed |
description | Background: Standard of Care (SoC) has been used with different significance across Randomized Clinical Trials (RCTs) on the treatment of Covid-19. In the context of a living systematic review on pharmacological interventions for COVID-19, we assessed the characteristics of the SoC adopted in the published RCTs. Methods: We performed a systematic review searching Medline, Pubmed, Embase, Cochrane Covid-19 register, international trial registers, medRxiv, bioRxiv, and arXiv up to April 10, 2021. We included all RCTs comparing any pharmacological intervention for Covid-19 against any drugs, placebo, or SoC. All trials selected have been classified as studies with SoC including treatments under investigation for COVID-19 (SoC+); studies with SoC without specifications regarding the potential therapies allowed (SoC-); studies including as control groups Placebo (P) or active controls (A+). Results: We included in our analysis 144 RCTs, comprising 78,319 patients. Most of these trials included SoC (108; 75.0%); some in all arms of the study (69.7%) or just as independent comparators (30.3%). Treatments under investigation for COVID-19 in other trials were included in the SoC (SoC+) in 67 cases (62.0%), Thirty-one different therapeutic agents (alone or in combination) were counted within the studies with SoC+: mostly hydroxychloroquine or chloroquine (28), lopinavir/ritonavir (20) or azithromycin (16). No specification was given regarding treatment allowed in the control groups (SoC-) in 41 studies (38.0%). Conclusion: Our analysis shows that the findings emerging from several clinical trials regarding the efficacy and safety of pharmacological intervention for COVID-19 might be jeopardized by the quality of control arms. |
format | Online Article Text |
id | pubmed-8558371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85583712021-11-02 The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review Addis, Antonio Amato, Laura Cruciani, Fabio Saulle, Rosella De Crescenzo, Franco Mitrova, Zuzana Vecchi, Simona Perrone, Francesco Davoli, Marina Front Pharmacol Pharmacology Background: Standard of Care (SoC) has been used with different significance across Randomized Clinical Trials (RCTs) on the treatment of Covid-19. In the context of a living systematic review on pharmacological interventions for COVID-19, we assessed the characteristics of the SoC adopted in the published RCTs. Methods: We performed a systematic review searching Medline, Pubmed, Embase, Cochrane Covid-19 register, international trial registers, medRxiv, bioRxiv, and arXiv up to April 10, 2021. We included all RCTs comparing any pharmacological intervention for Covid-19 against any drugs, placebo, or SoC. All trials selected have been classified as studies with SoC including treatments under investigation for COVID-19 (SoC+); studies with SoC without specifications regarding the potential therapies allowed (SoC-); studies including as control groups Placebo (P) or active controls (A+). Results: We included in our analysis 144 RCTs, comprising 78,319 patients. Most of these trials included SoC (108; 75.0%); some in all arms of the study (69.7%) or just as independent comparators (30.3%). Treatments under investigation for COVID-19 in other trials were included in the SoC (SoC+) in 67 cases (62.0%), Thirty-one different therapeutic agents (alone or in combination) were counted within the studies with SoC+: mostly hydroxychloroquine or chloroquine (28), lopinavir/ritonavir (20) or azithromycin (16). No specification was given regarding treatment allowed in the control groups (SoC-) in 41 studies (38.0%). Conclusion: Our analysis shows that the findings emerging from several clinical trials regarding the efficacy and safety of pharmacological intervention for COVID-19 might be jeopardized by the quality of control arms. Frontiers Media S.A. 2021-10-18 /pmc/articles/PMC8558371/ /pubmed/34733161 http://dx.doi.org/10.3389/fphar.2021.749514 Text en Copyright © 2021 Addis, Amato, Cruciani, Saulle, De Crescenzo, Mitrova, Vecchi, Perrone and Davoli. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Addis, Antonio Amato, Laura Cruciani, Fabio Saulle, Rosella De Crescenzo, Franco Mitrova, Zuzana Vecchi, Simona Perrone, Francesco Davoli, Marina The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title | The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title_full | The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title_fullStr | The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title_full_unstemmed | The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title_short | The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review |
title_sort | standard of care definitions on covid-19 pharmacological clinical trials: a systematic review |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558371/ https://www.ncbi.nlm.nih.gov/pubmed/34733161 http://dx.doi.org/10.3389/fphar.2021.749514 |
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