Status:
COMPLETED
Hydrocortisone for COVID-19 and Severe Hypoxia
Lead Sponsor:
Scandinavian Critical Care Trials Group
Collaborating Sponsors:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Covid-19
Hypoxia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.
Detailed Description
Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a pandemic of coronavirus disease (COVID-19) with many patients developing severe hypoxic respiratory failure. Many ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04348305
Start Date
April 17 2020
End Date
September 8 2021
Last Update
September 21 2021
Active Locations (14)
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1
Aarhus University Hospital - Dept of Intensive care
Aarhus, Denmark
2
Rigshospitalet
Copenhagen, Denmark, DK-2100
3
Dept of Infectious diseases, Rigshospitalet
Copenhagen, Denmark
4
Herlev Hospital - Dept. of Intensive Care
Herlev, Denmark