Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia

• Status: Active, not recruiting
• Trial end date: 2021-11-17
• Target enrollment: 0
• Participant gender: All

Summary

We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scandinavian Critical Care Trials Group
• Collaborators: Aalborg University Hospital; Aarhus University Hospital; Centre for Research in Intensive Care (CRIC); Copenhagen Trial Unit, Center for Clinical Intervention Research; Rigshospitalet, Denmark; The George Institute for Global Health, Australia
• Treatments: Dexamethasone

Criteria

Inclusion Criteria: All of the following must be fulfilled

• Aged 18 years or above AND

• Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND

• Use of one of the following:

• Invasive mechanical ventilation OR

• Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR

• Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system

Exclusion Criteria: We will exclude patients who fulfil any of the following criteria:

• Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents

• Use of systemic corticosteroids for COVID-19 for 5 days consecutive days or more

• Invasive fungal infection

• Active tuberculosis

• Fertile woman (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG

• Known hypersensitivity to dexamethasone

• Previously randomised into the COVID STEROID 2 trial

• Informed consent not obtainable