Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
E-pub ahead of print

Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: protocol and statistical analysis plan

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Long-term IV access in paediatrics - why, what, where, who and how

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  2. Preferences for the measurement and supplementation of magnesium, phosphate and zinc in ICUs: The international WhyTrace survey

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Continuous peripheral perfusion index in patients admitted to hospital wards - An observational study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Preferences for the measurement and supplementation of magnesium, phosphate and zinc in ICUs: The international WhyTrace survey

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. A causal relationship between rheumatoid arthritis and bronchiectasis? A systematic review and meta-analysis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear.

METHODS: The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol.

DISCUSSION: The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
ISSN0001-5172
DOI
StatusE-pub ahead of print - 14 feb. 2021

Bibliografisk note

This article is protected by copyright. All rights reserved.

ID: 62309673