Impact of systemic corticosteroids on hospitalized patients with COVID-19: January 2021 Meta-analysis of randomized controlled trials
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Abstract
Background
The COVID-19 pandemic has stimulated worldwide investigation into a myriad of potential therapeutic agents, including corticosteroids. The first RCT reporting results on the impact of systemic corticosteroids on COVID-19 in a peer reviewed journal was the RECOVERY trial published in July, 2020. The RECOVERY trial showed a reduced risk of 28-day mortality in patients who received oral or intravenous dexamethasone for 10 days.
This study is a meta-analysis of peer reviewed RCTs aims to estimate the association of systemic corticosteroid therapy compared to the usual care or placebo on all-cause mortality in hospitalized patients with COVID-19. Software based tools to accelerate the analysis process.
Methods
Meta-analysis of peer reviewed RCTs comparing systemic corticosteroids to usual care or placebo.
Results
Five English language RCTs were identified, including data from 7645 hospitalized patients worldwide using systemic dexamethasone, hydrocortisone and methylprednisolone in COVID-19 positive patients. Three RCTs were discontinued when preliminary results from the RECOVERY trial became available.
Meta-analysis of all identified RCTs showed no difference in survival in patients who received systemic corticosteroid therapy compared to usual care or placebo (Odds ratio 0.82, 95% CI 0.64-1.05, p = 0.09). Subgroup analysis from the 1967 critically ill patients in the identified RCTs showed improved survival in patients who received systemic corticosteroid therapy (Odds ratio 0.67, 95% CI 0.51-0.87, p = 0.01).
Conclusions
This meta-analysis of randomized controlled trials published in peer-reviewed literature by January 1, 2021 showed reduced mortality in critically ill patients but not all hospitalized patients with COVID-19 who received systemic corticosteroids. The early termination of three of the included RCTs because of the preliminary results of the RECOVERY trial is likely to have dramatically influenced the results of this meta-analysis. Further research is needed to clarify the role of systemic corticosteroid therapy in the management of COVID-19.
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SciScore for 10.1101/2021.02.03.21251065: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization The results of these searches were exported and filtered via the RobotSearch tool by Vortext Systems to identify randomized controlled trials12. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Identification of trials: Trials were identified by searching MEDLINE using the search terms COVID-19, corticosteroids, and steroids. MEDLINEsuggested: (MEDLINE, RRID:SCR_002185)The filtered results were reviewed for inclusion criteria and evaluated for bias via the RobotReviewer tool that applies the Cochrane Risk of Bias (RoB) tool to the full … SciScore for 10.1101/2021.02.03.21251065: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization The results of these searches were exported and filtered via the RobotSearch tool by Vortext Systems to identify randomized controlled trials12. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Identification of trials: Trials were identified by searching MEDLINE using the search terms COVID-19, corticosteroids, and steroids. MEDLINEsuggested: (MEDLINE, RRID:SCR_002185)The filtered results were reviewed for inclusion criteria and evaluated for bias via the RobotReviewer tool that applies the Cochrane Risk of Bias (RoB) tool to the full text of articles13. Cochrane Risk of Biassuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:This study has several important limitations. The focus on English language publications in peer reviewed literature by January 1, 2021 can cause a significant bias by under-representing the full spectrum of research in this rapidly evolving field. Remarkably, these 5 trials were conducted and published within 9 months of the World Health Organization declaration of the COVID-19 pandemic on March 11, 2020. The results of additional RCTs evaluating the use of systemic corticosteroids in COVID-19 have been published on pre-print servers and it is reasonable to expect these and other studies to be published in peer-reviewed literature. Because of this rapid pace of research and the promising potential impact of systemic corticosteroids on outcomes in COVID-19 infection, this meta-analysis will be updated on a regular basis. Treatment for COVID-19 has evolved considerably since the initiation of these studies. This can be clearly seen in the prevalence of other COVID-19 therapies outlined in table 2. The literature search and assessment methods used for this study were computer assisted, which differs from traditional meta-analysis techniques that are time and effort consuming. This strategy has the potential to introduce bias in the identification of RCTs. However, this methodology identified the same trials and did produce similar results (no statistically significant impact on survival) to a prospective meta-analysis conducted by the REACT Working Group and the van Paassen et ...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT02517489 Recruiting Community-Acquired Pneumonia : Evaluation of Corticosteroids NCT04327401 Terminated COVID-19-associated ARDS Treated With Dexamethasone: Allianc… NCT043881936 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT02735707 Recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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