Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.
- Petersen MW Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Meyhoff TS Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Helleberg M Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.
- Kjaer MN Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Granholm A Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Hjortsø CJS Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Jensen TS Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Møller MH Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Hjortrup PB Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Wetterslev M Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Vesterlund GK Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Russell L Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- Jørgensen VL Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.
- Tjelle K Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
- Benfield T Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
- Ulrik CS Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
- Andreasen AS Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
- Mohr T Department of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
- Bestle MH Department of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University of Copenhagen, Copenhagen, Denmark.
- Poulsen LM Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.
- Hitz MF Internal Medicine Department, Endocrinology, Zealand University Hospital, Køge, Denmark.
- Hildebrandt T Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.
- Knudsen LS Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.
- Møller A Department of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
- Sølling CG Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.
- Brøchner AC Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.
- Rasmussen BS Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
- Nielsen H Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
- Christensen S Department of Anaesthesia and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
- Strøm T Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.
- Cronhjort M Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
- Wahlin RR Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
- Jakob S Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Cioccari L Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Venkatesh B The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
- Hammond N The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
- Jha V The George Institute for Global Health, University of New South Wales, New Delhi, India.
- Myatra SN Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
- Gluud C Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
- Lange T Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
- Perner A Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.
- 2020-08-12
Published in:
- Acta anaesthesiologica Scandinavica. - 2020
English
INTRODUCTION
Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS
The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION
The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.
Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS
The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION
The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.
- Language
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- English
- Open access status
- bronze
- Identifiers
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- DOI 10.1111/aas.13673
- PMID 32779728
- Persistent URL
- https://sonar.ch/global/documents/67184
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