Hydrocortisone for COVID-19 and Severe Hypoxia

• Status: Completed
• Trial end date: 2021-09-08
• Target enrollment: 0
• Participant gender: All

Summary

We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.

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

Details

• Lead Sponsor: Scandinavian Critical Care Trials Group
• Collaborators: Aarhus University Hospital; Copenhagen Trial Unit, Center for Clinical Intervention Research; Rigshospitalet, Denmark; University of Copenhagen
• Treatments: Hydrocortisone; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

All the following criteria 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 any other indication than COVID-19

• Invasive mechanical ventilation for more than 48 hours

• Invasive fungal infection

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

• Known hypersensitivity to hydrocortisone

• A patient for whom the clinical team has decided not to use invasive mechanical ventilation

• Previously randomised into the COVID STEROID trial

• Informed consent not obtainable