Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials

Autor: Jonathan A. C. Sterne, Janet Diaz, Jesús Villar, Srinivas Murthy, Arthur S. Slutsky, Anders Perner, Peter Jüni, Derek C. Angus, Djillali Annane, Luciano Cesar Pontes Azevedo, Bin Du, Pierre-Francois Dequin, Anthony C. Gordon, Cameron Green, Julian P. T. Higgins, Peter Horby, Martin J. Landray, Giuseppe Lapadula, Amelie Le Gouge, Marie Leclerc, Jelena Savović, Bruno Tomazini, Balasubramanian Venkatesh, Steve Webb, John C. Marshall, for the WHO COVID-19 Clinical Management and Characterization Working Group
Přispěvatelé: Population Health Sciences [Bristol, Royaume-Uni], University of Bristol [Bristol], World Health Organization [Geneva], Hospital Universitario Doctor Negrín [Las Palmas de Gran Canaria, Spain], Ciber Enfermedades Respiratorias (Ciberes), Instituto de Salud Carlos III [Madrid] (ISC), University of British Columbia (UBC), University of Toronto, Rigshospitalet [Copenhagen], Copenhagen University Hospital, University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE), Infection et inflammation (2I), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospital Sírio-Libanês [São Paulo, Brazil], Peking Union Medical College Hospital [Beijing] (PUMCH), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Imperial College London, School of Public Health and Preventive Medicine [Monash University-Melbourne], Monash University [Melbourne], University of Oxford [Oxford], Oxford NIHR Biomedical Research Centre, San Gerardo Hospital, University of New South Wales [Sydney] (UNSW), Sterne, J, Diaz, J, Villar, J, Murthy, S, Slutsky, A, Perner, A, Juni, P, Angus, D, Annane, D, Azevedo, L, Du, B, Dequin, P, Gordon, A, Green, C, Higgins, J, Horby, P, Landray, M, Lapadula, G, Le Gouge, A, Leclerc, M, Savovic, J, Tomazini, B, Venkatesh, B, Webb, S, Marshall, J, National Institute for Health Research, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Glucocorticoids/therapeutic use
Letter
Hydrocortisone
Medicine (miscellaneous)
Research & Experimental Medicine
Adrenal Cortex Hormone
WHO COVID-19 Clinical Management and Characterization Working Group
Dexamethasone
law.invention
0302 clinical medicine
Glucocorticoid
Randomized controlled trial
Adrenal Cortex Hormones
law
Medicine
Corticosteroid
Pharmacology (medical)
Prospective Studies
030212 general & internal medicine
Prospective cohort study
1102 Cardiorespiratory Medicine and Haematology
Randomized Controlled Trials as Topic
Randomised controlled trial
lcsh:R5-920
3. Good health
Medicine
Research & Experimental
Meta-analysis
Critical Illne
lcsh:Medicine (General)
Coronavirus Infections
Life Sciences & Biomedicine
Human
medicine.medical_specialty
Randomization
Critical Illness
Pneumonia
Viral
Adrenal Cortex Hormones/therapeutic use
Placebo
Methylprednisolone
Betacoronavirus
03 medical and health sciences
General & Internal Medicine
Internal medicine
Humans
Meta-analysi
Methylprednisolone/therapeutic use
Mortality
Adverse effect
Glucocorticoids
Pandemics
Hydrocortisone/therapeutic use
Science & Technology
Betacoronaviru
Pandemic
business.industry
Coronavirus Infection
SARS-CoV-2
COVID-19
1103 Clinical Sciences
Coronavirus Infections/drug therapy
Odds ratio
Pneumonia
Viral/drug therapy
Dexamethasone/therapeutic use
COVID-19 Drug Treatment
Clinical trial
Prospective Studie
Cardiovascular System & Hematology
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Systematic Review
business
030217 neurology & neurosurgery
Zdroj: Trials
Trials, BioMed Central, 2020, 21 (1), ⟨10.1186/s13063-020-04641-3⟩
Sterne, J A C, Diaz, J, Villar, J, Murthy, S, Slutsky, A S, Perner, A, Jüni, P, Angus, D C, Annane, D, Azevedo, L C P, Du, B, Dequin, P-F, Gordon, A C, Green, C, Higgins, J P T, Horby, P, Landray, M J, Lapadula, G, Le Gouge, A, Leclerc, M, Savović, J, Tomazini, B, Venkatesh, B, Webb, S, Marshall, J C & WHO COVID-19 Clinical Management and Characterization Working Group 2020, ' Corticosteroid therapy for critically ill patients with COVID-19 : A structured summary of a study protocol for a prospective meta-analysis of randomized trials ', Trials, vol. 21, 734 . https://doi.org/10.1186/s13063-020-04641-3
Trials, Vol 21, Iss 1, Pp 1-3 (2020)
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04641-3⟩
Popis: Objectives Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. Study design Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. Participants Hospitalised, critically ill patients with suspected or confirmed COVID-19. Intervention and comparator Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. Main outcome All-cause mortality up to 28 days after randomization. Search methods Systematic searching of clinicaltrials.gov, EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials. Risk of bias assessments These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. Summary of findings We will use GRADE to assess the certainty of the evidence. Statistical analyses Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms). PROSPERO registration number CRD42020197242 Full protocol The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.
Databáze: OpenAIRE
Externí odkaz: