Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.

Petersen, Marie Warrer; Meyhoff, Tine Sylvest; Helleberg, Marie; Kjær, Maj-Brit Nørregaard; Granholm, Anders; Hjortsø, Carl Johan Steensen; Jensen, Thomas Steen; Møller, Morten Hylander; Hjortrup, Peter Buhl; Wetterslev, Mik; Vesterlund, Gitte Kingo; Russell, Lene; Jørgensen, Vibeke Lind; Tjelle, Klaus; Benfield, Thomas; Ulrik, Charlotte Suppli; Andreasen, Anne Sofie; Mohr, Thomas; Bestle, Morten H; Poulsen, Lone Musaeus; ... (2020). Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan. Acta anaesthesiologica Scandinavica, 64(9), pp. 1365-1375. Wiley-Blackwell 10.1111/aas.13673

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Jakob, Stephan and Cioccari, Luca

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0001-5172

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Jsabelle Arni

Date Deposited:

14 Aug 2020 11:14

Last Modified:

07 Dec 2020 01:31

Publisher DOI:

10.1111/aas.13673

PubMed ID:

32779728

BORIS DOI:

10.7892/boris.145953

URI:

https://boris.unibe.ch/id/eprint/145953

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