Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04348305
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04348305
Study Brief:
Protocol Section:
NCT04348305