ow dose hydrocortisone in patients with COVID-19 and severe oxygen deficiency – the COVID STEROID trial

Phase 1

• Conditions: Adult patients with COVID-19 and severe hypoxia.; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; MedDRA version: 21.1Level: PTClassification code 10021143Term: HypoxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001395-15-DK
• Lead Sponsor: Deparment of Intensive Care, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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) OR
•Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

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
- Consent not obtainable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified